Explore the complete list of our presses below (Page 1 of 1):
Chronic disease drugs fueling Indian pharma boom! Industry to see double-digit growth with new product launches.
A study reveals nearly 2 million people in England and Scotland suffer from long COVID, impacting daily activities and workforce participation.
AbbVie & Gilgamesh join forces to develop neuroplasticity-based treatments for mood & anxiety disorders.
Infinity Labs doubles down on quality! ISO certification ensures excellence in chemical & microbiological testing.
India's Bharat Biotech & Bilthoven team up to ensure reliable supply of Oral Polio Vaccine (OPV) worldwide.
Breakthrough in liver disease treatment! New collaboration focuses on regenerative therapies for chronic liver disease.
The FDA warned Cardinal Health for distributing unapproved Chinese syringes under the Monoject brand, citing risks to medical device safety and compliance.
Catalent plans to lay off 130 employees in Bloomington, Indiana, as part of its restructuring, despite a $16.5B acquisition offer from Novo Holdings.
Zydus Lifesciences secures US FDA approval for Dapsone Gel 7.5%. An effective acne treatment, it targets bacterial growth and inflammation.
Charles River demonstrates its commitment to environmental responsibility through investments and partnerships.
Cresset establishes its new India headquarters in Bangalore to serve the expanding market for computational drug discovery solutions in Asia Pacific.
NHS patients with PAH to benefit from cutting-edge digital technology - personalized care for a life-threatening condition.
DP007 - a new hope for respiratory patients and the planet! Lowers global warming potential compared to current inhalers.
FDA approves Roche's Lp(a) test - a game-changer for identifying patients who can benefit from innovative cholesterol-lowering treatment.
A child in Ontario has died of measles, marking the first such death in a decade. The child was unvaccinated, highlighting concerns about vaccine hesitancy.
Funding boost for Grey Wolf Therapeutics' innovative approach to fighting cancer and autoimmune diseases.
GSK's depekomab targets eosinophilic asthma, offering new hope for millions struggling with severe asthma.
AstraZeneca admits rare thrombosis with thrombocytopenia syndrome (TTS) risk in its COVID-19 vaccine. Legal acknowledgment may lead to settlements.
Eli Lilly expands Indiana plant with a $9 billion investment, creating hundreds of new jobs and boosting production of key diabetes and obesity drugs.
New technology slashes cell therapy production costs by automating the process, paving the way for wider access.
Nestle introduces Vital Pursuit, a $5 line of frozen pizzas and protein pasta for people on weight-loss drugs Wegovy and Ozempic, packed with nutrients.
NIBRT launched a new advanced therapies facility in Dublin, expanding research and training for innovative biomedicines like gene therapies and vaccines.
Novartis invests $256M in Singapore to expand antibody drug manufacturing, boost efficiency with digital tech, and create 100 skilled jobs.
The global pharmaceutical chemicals market is projected to grow at a CAGR of 4.9%, reaching $278.76 billion by 2029, driven by demand for novel medicines and contract manufacturing.
India’s pharmaceutical sector sees Rs 28,328 crore investment under PLI scheme, with significant growth in bulk drugs and medical devices.
Don't miss Pharma Now's latest offerings! Explore innovations & resources at the PharmaLabChem Expo.
Recce Pharmaceuticals ramps up production of new synthetic antibiotic to combat global health threat.
Promising results from Zerion Pharma's Dispersome® technology suggest it could improve existing cystic fibrosis treatments.
Sartorius and TheWell Bioscience join forces to develop innovative 3D cell models, potentially revolutionizing drug testing.
Schreiner MediPharm's innovative service tailors RFID labels on demand, reducing costs and boosting pharmaceutical supply chain efficiency.
Shweta Munjal becomes Chief Communication & CSR Officer at Glenmark Pharmaceuticals, bringing 20+ years of leadership in communications, marketing, and CSR.
South Korea faces a worsening doctor shortage in small cities, amplified by a 3-month trainee doctor strike against policies to boost medical school admissions.
Strides Pharma’s subsidiary gets USFDA approval for generic Sucralfate Oral Suspension, 1gm/10ml, for treating ulcers and GERD, with a market size of USD 124M.
Sun Pharma acquires the remaining 21.52% of Taro Pharmaceuticals for ₹2,891.76 crore, completing the merger, and Taro's shares will be delisted from NYSE.
Sygnature Discovery earns EcoVadis Bronze rating, placing in the top 35% globally for environmental, social, and ethical performance in the life sciences sector.
Learn about TekniPlex Healthcare's participation in The Pharma Days event, where they will showcase their range of sustainable blister packaging solutions.
The U.S. proposes reclassifying marijuana to Schedule 3 to promote research, easing restrictions for cannabis companies, and enabling stock exchange listings.
Thermo Fisher is to lay off 74 employees at its Carlsbad plasmid DNA facility by May 31, 2024, citing demand fluctuations, per a WARN Act report.
Torbay Pharma appoints new COO and CPO to boost growth in North America, addressing supply chain challenges and rising demand for essential medicines.
TriLink BioTechnologies teams up with Johns Hopkins University to accelerate RNA therapeutics research with CleanScript.
Bayer concludes its joint venture with Zydus Lifesciences, acquiring full ownership of Bayer Zydus Pharma Private Ltd.
UPS Healthcare opens a new logistics facility in Dublin, providing end-to-end solutions and creating 30 new jobs.
New FDA regulations enforce stringent oversight of Laboratory Developed Tests to ensure their safety and effectiveness.
New clinical trial reveals promising outcomes for a personalised liver cancer vaccine, showing significant tumour regression.
Register for the “Sterility Testing in Pharmaceuticals” webinar by MicroVerse on June 9, 2024, featuring expert insights and networking.
British pharmacies cut prices on weight-loss treatments Wegovy and Mounjaro amid high demand and competitive market dynamics.
The World Bank Group commits to extending affordable healthcare access to 1.5 billion individuals by 2030 through innovative strategies and partnerships.
Novo Nordisk's weight-loss drug Wegovy shows promise for obese individuals with specific genetic profiles, aiding targeted weight loss.
Torrent Pharma tackles heartburn! Launches Kabvie, a new drug for GERD in India. Expected to be a game-changer for millions.
Confused about Biosimilars? Get the facts on how they offer same benefits as biologics at a fraction of the cost.
Orano Med's new lab to produce 100,000 lead-212 doses annually, offering a powerful new weapon against cancer.
FDA inspection finds major issues at Hengrui's China facility. Contamination control, cleaning & documentation flagged.
Vetter is expanding its U.S. and Germany operations, moving its facility to Des Plaines, and investing in Saarlouis, creating 2,000 jobs by 2030.
Big news in gut health! Nestlé acquires VOWST, a promising therapy to prevent C. Diff recurrence, expanding its reach in microbiome treatment.
The Pharma Packaging market is on fire! A new report predicts a surge to over $15 billion by 2032, driven by sustainability & automation.
GSK's Blenrep, combined with pomalidomide and dexamethasone, significantly reduces multiple myeloma progression risk by 50%
Wockhardt UK steps up! Secures £20 million funding to modernize facilities & expand vaccine production. Read more about their plans here.
Healthcare logistics on the rise! Market expected to surge by $121 billion by 2028, driven by pharma sales & cold chain advancements.
how BioXcel Therapeutics' AI platform accelerates drug development and promotes sustainability through efficient drug repurposing.
Schneider Electric takes center stage at ACHEMA 2024! EcoStruxure for Life Sciences promises to revolutionize sustainable pharma manufacturing.
Syntegon ups its game! Global leader acquires Telstar, boosting liquid pharma processing & freeze-drying solutions. Read the full story here.
FDA approves trials for Lomonitinib - a promising new drug for FLT3-mutated AML. Learn more about this potential breakthrough.
Cash Offer Alert! Cycle Pharmaceuticals steps up with an $8 per share bid to acquire Vanda. See how this could impact the rare disease market.
Syntegon's new Settle Plate Changer at Achema 2024 revolutionizes aseptic processing with enhanced automation and compliance.
Discover Antares Vision Group's HR600 PHC at ACHEMA 2024, showcasing milligram-level precision and autonomous error detection for ultimate quality control.
TurboFil Packaging Machines and Amneal Pharmaceuticals are partnering to create an automated naloxone vial assembly and filling machine.
Discover survodutide, a dual GLP-1 and glucagon agonist, showing promise in treating fibrosis and obesity with positive trial results.
NRx Pharmaceuticals advances next-gen ketamine therapy for severe depression, offering rapid, safe relief for treatment-resistant mental health disorders.
Explore the $1.6 billion partnership formed between Ipsen and Marengo in 2022 to advance precision immuno-oncology candidates from Marengo’s STAR platform.
Discover the groundbreaking partnership between Incepta Pharmaceuticals and MCRI to combat rotavirus infections in children.
BioXcel Therapeutics uses AI to accelerate drug development, focusing on sustainability and cost-effective drug repurposing.
Recce Pharmaceuticals completes dosing in Phase I/II UTI/Urosepsis trial of RECCE® 327, with data review by an Independent Safety Committee pending.
Lupin partners with OLIC Limited to distribute Nextstellis oral contraceptives in Vietnam and the Philippines, enhancing Lupin's women's health portfolio.
IPA's 9th Global Pharmaceutical Quality Summit in Mumbai on June 27-28 will focus on 'Advances in Manufacturing and Quality – Patient Centricity.'
Biocon appoints Mukesh Kamath as Interim CFO starting June 11, 2024. Kamath brings extensive finance experience from his 20-year tenure at Biocon.
ACG partners with EY-Parthenon to achieve net zero emissions and comply with the EU's CBAM, focusing on sustainability and carbon footprint reduction.
The YpsoMate 1.0 autoinjector simplifies methotrexate injections with a two-step process, safety features, and an ergonomic design for easy, secure use.
94% of pharma execs adapt revenue management for regulatory changes. CMS delays rule on aggregating discounts, seen as positive by Model N's Mendelsohn.
Evotec advances in neuroscience with Bristol Myers Squibb, earning $20M. Pre-clinical progress boosts neurodegenerative disease pipeline.
Delhi-based pharmaceutical firm in talks with PE firms for joint bid on BSV. Mankind Pharma plans fundraising for acquisitions and growth.
Dr. Reddy's secures exclusive US rights for Cyclophosphamide injection from Ingenus Pharmaceuticals, sharing 50% of profits.
Torrent Pharma's Indrad plant faces compliance scrutiny with a Form 483 from USFDA, citing five observations post-inspection.
Krista McKerracher, new Chairperson at Genialis, drives RNA-based biomarkers for personalized medicine, focusing on global patient outcomes in biopharma.
Stefan Doboczky, new Borealis CEO, focuses on advancing innovation, sustainability, and market leadership in the global chemicals sector.
EU Antitrust regulators charged Alchem International with price-fixing in a cartel for SNBB, risking fines up to 10% of global turnover.
BioCina secures exclusive rights to CelluTx's RBPS tech for efficient mcDNA production, enhancing gene therapies and biologics manufacturing.
ABIONYX Pharma completes pre-IND meeting with FDA, plans IND filing for apoA-I-based drug, advancing treatments for sepsis and critical care.
AbbVie and FutureGen collaborate on FG-M701, a promising TL1A antibody for IBD, with a $1.56 billion potential milestone and royalties deal.
The BreAK-CRC study tests STC-1010 cancer vaccine in advanced colorectal cancer across 9 EU/US centers, aiming for improved outcomes in cold tumors.
Suven Pharma to acquire 67.5% of Sapala Organics for Rs 229.5 crore, boosting nucleic acid therapy and ADC technology capabilities.
Takeda and Ascentage partner for global rights (ex-China/Russia/Taiwan/Macau/HK) to olverembatinib, a CML TKI, with $100M option payment and milestones.
Mankind Pharma's #RippleOfChange campaign promotes life-saving blood donations in India on World Blood Donor Day.
Sun Pharma and Moebius Medical's MM-II offers durable knee OA pain relief, paving the way for Phase 3 trials and EU approval.
Lupin's Nagpur facility passes USFDA inspection with no observations, ensuring high-quality standards upheld globally.
Wacker's new mRNA centre in Halle boosts vaccine production capacity, enhancing pandemic preparedness globally
Takeda plans potential $1.3B acquisition of Ascentage Pharma's innovative CML treatment olverembatinib
Enveda Biosciences raises $55M, totaling $119M in Series B funding, to advance AI-driven drug discovery and clinical trials for novel therapies by 2025.
Jagsonpal Pharmaceuticals has revealed that it has acquired businesses of Yash Pharma in India and Bhutan. Read the full news here!
DHL Enhances Pharma Logistics In France, Which Will Ultimately Result In Driving Innovation in Healthcare Supply Chain.
Discover the latest findings on RADICAVA® for ALS presented by Mitsubishi Tanabe Pharma at ENCALS 2024. Learn about new insights and study results.
Johnson & Johnson faces a $150M verdict over allegations of breaching marketing practices for HIV medications, intensifying legal battles.
Elion receives $81M funding to advance antifungal therapy, accelerating development and innovation in treatments.
Fosun Pharma to divest a 5% stake in Gland Pharma, raising $172 million in the transaction. This move is part of Fosun Pharma's strategic portfolio adjustment.
ALPLA Group expands its pharma packaging prowess with the acquisition of Heinlein Plastik-Technik GmbH, improving innovation in pharma packaging solutions.
Alembic Pharma achieves significant milestone as U.S. FDA approves Dabigatran Etexilate Capsules, signalling a breakthrough in pharmaceutical innovation.
Ascidian Therapeutics and Roche partner to advance medical research, aiming for breakthroughs in future treatments, shaping the future of medicine together.
Discover MilliporeSigma's €62M state-of-the-art quality control facility in Germany, setting new standards in life sciences innovation and efficiency.
Indian pharma giant Cipla invests EUR 3 million in German biotech firm Ethris, boosting innovative research and development in mRNA-based therapies.
Thermo Fisher's new clinical research hub in Wisconsin, advancing innovation and healthcare solutions. Read the whole news here!
Alvotech partners with Advanz Pharma to distribute AVT06 and AVT29, biosimilars of Eylea, enhancing access to eye disease treatments across Europe.
Belharra Therapeutic’s strategic alliance with Sanofi, aimed at advancing small molecule treatments for immunological disorders.
FDA approves Pryos Pharmaceuticals' Vigafyde, a new vigabatrin oral solution for infantile spasms in children, marking first new formulation in 15 years.
PCI Pharma Services signs a 25-year lease for an 82,000 sq ft facility in Stamullen, enhancing production and sustainability by Q1 2025.
Corealis Pharma expanded $10M facilities in Laval, boosting R&D and production capabilities, aiming to become a global leader in oral solid dosage formulations.
Zydus Lifesciences defends Biotax 1gm amid Nepal's quality concerns, asserting compliance with standards. Details on Business Standard.
AstraZeneca's Truqap, combined with paclitaxel, failed to meet primary endpoints in a trial for metastatic triple-negative breast cancer.
FDA issues warning letter citing violations in cGMP regulations at Sun Pharma's Dadra unit, impacting stock.
Kotak Alt invests Rs. 1,445 crore in Matrix Pharma’s API business, making it the 2nd largest ARV API player in India, expanding global collaborations.
Sun Pharma partners with Takeda to launch Voltapraz (Vonoprazan) in India, offering innovative treatment for reflux esophagitis and acid-related disorders.
Bora Pharmaceuticals expands its capabilities with the acquisition of Emergent BioSolutions’ sterile manufacturing plant in Baltimore-Camden, Maryland.
Discover Zealand Pharma's Phase 1b trial results on petrelintide for weight management. Learn more about this innovative biotechnology advancement today.
Pharma leader wins major international tenders for vital antibiotics and oncology drugs, enhancing global healthcare and boosting India's export influence.
The European Commission approves Takeda's FRUZAQLA for metastatic colorectal cancer, offering a new, effective treatment option for advanced-stage patients.
Abzena and Argonaut team up to enhance biopharmaceutical development, offering integrated solutions for faster, efficient therapy delivery
Sanofi and Biovac announce a collaboration to localize inactivated polio vaccine (IPV) production in Africa for 40+ countries, bolstering vaccine access and regional capacity.
GL0034, Sun Pharma's latest drug for obesity treatment, demonstrates significant weight loss and improved metabolic health in Phase 1 trials.
Lupin’s New Jersey facility earns a positive FDA report, enhancing its compliance reputation in the pharmaceutical industry.
Phio Pharmaceuticals secures a South Korean patent for RXI-185, targeting UV-induced aging and enhancing its skin care and cancer treatment portfolio.
FDA initiates surprise inspection at Sun Pharma's Mohali plant after finding manufacturing violations at Halol site.
Biocon Biologics gets EMA nod to produce Bevacizumab in Bengaluru, renews GMP certifications for facilities in India & Malaysia, ensuring top-quality standards.
Teva Pharmaceuticals to acquire Labrys Biologics for over $800M, expanding its migraine treatment lineup with promising drug LBR-101.
KDDF funds CHA Biotech's CBT101 R&D for two years, advancing NK cell therapy for recurrent glioblastoma to phase 2 trials and aiming for IND approval.
Lupin and Aurobindo Pharma recall products from the US market due to FDA alerts on manufacturing issues.
Biocon's API facility in Visakhapatnam, Andhra Pradesh, receives four observations from US FDA following inspection. Read more on the regulatory update.
Bharat Biotech includes ICMR as co-owner of Covid-19 vaccine patent, affirming commitment to collaboration and timely vaccine development.
Discover GSK's latest milestone, Omjjara (momelotinib) approved by Japan's MHLW for myelofibrosis treatment, offering hope to patients worldwide.
GSK's application to expand Jemperli with chemotherapy for all advanced or recurrent endometrial cancer patients is accepted by EMA.
Novo Nordisk announces a $4.1 billion investment in Clayton, NC, doubling production capacity for injectable treatments, creating 1,000 jobs.
Xellia's latest layoffs follow the sale of its assets to Hikma, impacting roles at its Bedford facility in the U.S.
ANI acquires Alimera, advancing their Rare Disease portfolio in ophthalmology. Expect enhanced patient care and strategic synergies.
Wacker and CordenPharma enter pandemic-ready state, poised to produce 80 million vaccine doses annually in response to future outbreaks. Learn more.
Silence Therapeutics receives a $2M milestone payment from Hansoh Pharma, advancing their mRNAi GOLD platform to tackle genetic diseases.
ProBio Inc. launches a new 128,000 sq ft facility in Hopewell, NJ, boosting plasmid DNA and viral vector production for cell and gene therapy in North America.
Parse Biosciences partners with Gencell Pharma to expand single-cell sequencing solutions in South America, enhancing research capabilities.
Glenmark Pharmaceuticals recalls 114 batches of 750mg potassium chloride capsules due to dissolution issues, posing hyperkalemia risks.
CSPC Pharmaceutical Group advances with China's approval for mRNA-based cancer cell therapy trial, setting new standards in medical innovation.
CatSci Ltd acquires Reach Separations, enhancing chromatography services from discovery to manufacturing with support from Keensight Capital.
Discover Thermo Fisher's IntelliStack Incubator & CO2 Incubator Shakers—revolutionizing growth environments with precision and reliability for life sciences.
Haelium pioneers pharmaceutical innovation with high-purity solutions and advanced drug delivery products, ensuring global health advancements.
Haleon divests Nicotinell business to Dr. Reddy's, enhancing strategic focus while expanding consumer healthcare capabilities globally.
FDA approves Verona Pharma's Ohtuvayre for COPD. First non-steroidal inhaled treatment, boosting lung function.
Bora Pharmaceuticals acquires Emergent BioSolutions' Camden facility, boosting U.S. presence and sterile manufacturing capabilities.
Nxera Pharma hits a $10M milestone in neurological disease R&D with AbbVie, advancing novel GPCR targets. Potential $1.2B in milestones ahead!
Read how Rhenopharma Group enhances its global pharmaceutical services with the acquisition of Konapharma AG, a leading Swiss contract manufacturer.
Veranova invests $30M to expand its Devens facility, enhancing capabilities in ADC and potent compound development to meet growing US demand.
Jagsonpal acquires Yash Pharma, expanding into dermatology and pediatrics, enhancing market position.
Stay updated on CDSCO's risk-based inspections and new initiatives to enhance drug quality in India's pharmaceutical industry.
Aurobindo Pharma announces US inspection results, partnership with Merck Sharp & Dohme, and strong Q4 FY24 financial performance.
Rocket Pharmaceuticals' shares drop 12% as FDA delays approval of their gene therapy for a rare pediatric disorder, seeking more process information.
Lupin Ltd acquires Gavis Pharmaceuticals LLC and Novel Laboratories Inc. for $880 million, enhancing US market presence with expanded generics pipeline.
Alembic Pharmaceuticals' latest FDA-approved Doxycycline Capsules, 40 mg, for treating rosacea, propel stock surge and market growth.
A milestone in Wockhardt’s clinical trials as Zaynich, an investigational drug, effectively treated a young cancer patient with compromised immunity in the US.
Discover Alembic Pharmaceuticals' latest achievement as their Gujarat oncology facility secures US FDA's Establishment Inspection Report (EIR).
Discover Eisai's new dementia treatment targeting tau protein, aiming for U.S. launch by 2030. Leqembi also set for China debut.
A judge dismissed cancer victims' bid to block Johnson & Johnson's $6.48B talc settlement, stating potential harm was hypothetical. Voting deadline is July 26.
Biogen secures Tecfidera patents after U.S. board rules in its favor, ending royalty dispute with Forward Pharma, impacting stock prices.
President Bola Ahmed Tinubu signs Executive Order to reduce drug prices in Nigeria, eliminating tariffs and VAT on healthcare equipment and raw materials.
ARS Pharma's needle-free nasal spray, EURneffy, gets EMA's nod. Awaiting FDA approval by October 2. Positive results and advocacy groups' support add momentum.
Regeneron Pharma receives CHMP's positive opinion for odronextamab, targeting relapsed/refractory follicular & diffuse large B-cell lymphomas in Europe.
Alembic Pharmaceuticals receives USFDA tentative approval for Bosutinib Tablets, used to treat chronic myelogenous leukemia. Market size estimated at US$ 275M.
Kanvas Biosciences, a full-stack spatial biology company, has raised $12.5 million in additional funding. This brings Kanvas's total funding to $29.5 million.
AstraZeneca has announced that the EU drug regulator has accepted a market authorisation app for Sipavibart, under an accelerated assessment.
With the Union Budget 2024 approaching, the pharma industry is hoping to get better incentives for R&D and grow market size to $120-$130 billion.
Cassava Sciences, a Texas-based pharmaceutical company, will form a committee to evaluate new probes by U.S. regulators and investigate two senior employees.
TauRx Pharma has applied to the UK Medicines and Healthcare Products Regulatory Agency for approval of hydromethylthionine mesylate to treat Alzheimer's disease
Alcon acquires BELKIN Vision for $81M, enhancing glaucoma treatment with DSLT technology, aiming for US market entry.
MBK Partners to acquire Japan's Alinamin Pharmaceutical for 350B yen, boosting its presence in the Asian pharma market.
Media partnership announcement between Pharma Now and the Indian Pharmaceutical Congress for the IPC Expo in Hyderabad.
Pharma Now announces its media partnership with the 14th National Exhibition, Asia Labex 2024 in Gandhinagar.
Semnur Pharma to go public via $2B merger with SPAC, focusing on non-opioid pain treatment SP-102 for sciatica.
Samsung Biologics inks $1.06B deal with unnamed U.S. pharma, boosting manufacturing amid BIOSECURE Act concerns.
Eli Lilly partners with Radionetics Oncology for $140M, with a $1B acquisition option to advance radiopharmaceuticals.
Codexis sells investigational compounds for Fabry and Pompe diseases to Crosswalk Therapeutics, securing milestone payments.
Legal battle over Covid-19 vaccine patents: Moderna wins partial victory against Pfizer and BioNTech in UK court.
GSK leads on new mRNA flu and COVID vaccines with CureVac, gaining full control; CureVac receives €400M upfront plus milestones.
Pharma Now partners with the Digital Transformation in Life Science R&D Conference. Don't miss this pivotal event!
Radionetics Oncology partners with Eli Lilly to develop GPCR-targeted radiopharmaceuticals for treating solid tumors.
Mankind Pharma aims to acquire Bharat Vaccines and Serums for $1.7-$2B, enhancing its market presence in critical healthcare.
Sun Pharma acquires 85.1% of JSC Biosintez for $24M to boost its Russian market presence with local manufacturing.
"SIRTURO® achieves FDA and EC full approvals for MDR-TB, marking a pivotal advancement in TB treatment."
Aurigene partners with Edity Therapeutics to provide discovery services for cell therapy, boosting clinical development in oncology, gene therapy, and more.
Herantis Pharma tests HER-096 for safety in Parkinson’s, aiming to protect and restore dopamine-producing brain cells.
Philogen and Sun Pharma's Nidlegy™ MAA validated by EMA, aims to treat locally advanced, resectable melanoma.
Viatris sold its OTC business to Cooper Consumer Health, finalizing a $3.37B divestiture plan to refocus and reinvest.
AstraZeneca to invest Rs 250 crore in Chennai, creating 1,300 jobs and expanding its Global Innovation and Technology Centre.
Torque Pharma wins "Best Healthcare Brand of 2024" by ET Edge, launches 'Better Together' rebranding for global expansion.
Aluflexpack launches 4∞ Form, a fully recyclable aluminium blister pack for the pharmaceutical industry, reducing waste.
Direct Pharma Logistics expands into Bulgaria with Medex, plans Moldova entry, aiming for 50M euros turnover, says Forbes.ro.
AstraZeneca's Tagrisso, approved by the EU, combines with chemotherapy for first-line NSCLC treatment in adults with EGFR mutations, improving survival rates.
Federal judge dismisses Boehringer Ingelheim's challenge to Medicare drug price negotiation, dealing a blow to pharma's legal stance.
Emcure Pharmaceutical's IPO raises Rs 1,952 crore, subscribed 67.87 times. Backed by Bain Capital, priced Rs 960-1,008 per share for Rs 19,060 crore valuation.
Pulsus Group, led by CEO Dr. Srinubabu Gedela, announces a Rs 300 crore AI-driven pharma healthcare IT hub in Ameenpur, Telangana.
GSK plc and Medicines for Malaria Venture introduce a groundbreaking single-dose medication, tafenoquine, to prevent Plasmodium vivax malaria recurrence.
Recce Pharmaceuticals' R327 shows promising results, achieving over 99.99999% reduction in superbug Acinetobacter baumannii, outperforming ciprofloxacin.
Yuhan Corp. and ProGen announce R&D collaboration to develop innovative drugs for obesity and diabetes using bispecific antibody platform.
Ascentage Pharma's olverembatinib approved in Macau for treating resistant CML, expanding regional reach and collaborations.
Valeant ups Salix bid to $10.96B, outbidding Endo in major cash deal, marking its largest acquisition with financial and strategic implications.
Myricx Bio, a UK-based biotech firm, secured £90M to expand its NMT inhibitor ADC platform, backed by Novo Holdings, Abingworth, and other key investors.
Novartis, Pfizer, Otsuka, and Novo Nordisk reprimanded by PMCPA for ABPI code breaches. Novo Nordisk faces public reprimand over £7.8M.
Lotte Biologics breaks ground on its first plant in Incheon, marking a 4.6 trillion won investment and a significant step in Korea's biotech industry.
Aptamer Group plc collaborates with AstraZeneca to enhance siRNA delivery using Optimer binders, targeting fibrotic liver cells for innovative gene therapies.
Biostar Pharma's Utidelone Injection gets FDA approval for a Phase 2 study targeting HER2- breast cancer brain metastasis.
Körber partners with Anrate Biopharmaceutical to enhance operations with advanced manufacturing solutions for a smart factory in China's biopharma sector.
MedPharm merges with Tergus Pharma to form a CDMO, enhancing drug development and manufacturing services globally. Majority owned by Ampersand Capital Partners.
IASO Bio acquires global rights to FUCASO® from Innovent Biologics, expanding its cell therapy portfolio for treating multiple myeloma and autoimmune diseases.
Roche announces the re-release of Susvimo® for intravitreal use in the US, offering a new ocular implant for neovascular AMD treatment, following FDA approval.
ORLADEYO® approved by DIGEMID in Peru for preventing hereditary angioedema attacks in adults and children aged 12+, a milestone in treatment options.
Emergent BioSolutions to receive $50M from Johnson & Johnson to settle COVID-19 vaccine production dispute, ending a problematic collaboration.
Discover YARAL Pharma, supplying exclusive gel-cap levothyroxine sodium for hypothyroidism treatment in the U.S., made for absorption & allergen-free benefits.
Discover Shilpa Pharma Lifesciences, Raichur, Karnataka. Awarded ANVISA GMP Certification for oncology and non-oncology APIs, ensuring global quality standards.
Alembic Pharmaceuticals secures USFDA approval for its generic Bromfenac Ophthalmic Solution, boosting its ANDA approvals to 207 with a market size of $168M.
Reviva Pharmaceuticals secures European Patent for brilaroxazine to treat pulmonary hypertension, expanding their CNS and cardiometabolic treatment portfolio.
XyloCor Therapeutics teams with SmartWise to advance gene therapy for refractory angina using the innovative Extroducer® Catheter System®.
OKYO Pharma pioneers therapies for dry eye disease and neuropathic corneal pain, unveiling Phase 2 trial insights on key symptom endpoints.
Elevar Therapeutics announces intention to resubmit NDA for rivoceranib and camrelizumab, advancing treatment for Unresectable Hepatocellular Carcinoma.
Thermo Fisher Scientific finalizes $3.1B acquisition of Olink Holding AB, enhancing its proteomics solutions and expanding capabilities in life sciences.
Evotec SE and Pfizer announce a multi-year research collaboration targeting metabolic and infectious diseases.
Novo Nordisk and Bio Farma partner to enhance insulin packaging in Indonesia, combining Novo's diabetes care expertise with Bio Farma's local infrastructure.
Pfizer selects preferred once-daily formulation for danuglipron, advancing in obesity treatment. Study shows promising pharmacokinetics and safety profile.
MedPharm, Ltd. and Tergus Pharma merge to form a leading CDMO specializing in topical and transepithelial products, led by CEO Michael Kane.
Novo Nordisk receives FDA Complete Response Letter for once-weekly basal insulin icodec, addressing manufacturing and type 1 diabetes indication concerns.
Sichuan Biokin Pharmaceutical Co. aims to raise $500M through a Hong Kong IPO, with Goldman Sachs, JPMorgan, and Citic as joint sponsors
Algernon Pharmaceuticals announces a non-brokered private placement to raise $250,000 via units priced at $0.12 each, closing July 20, 2024.
Merz Therapeutics boosts its neurology portfolio by acquiring INBRIJA® and AMPYRA®, enhancing treatments for Parkinson's disease and entering the MS market.
FDA raids in Vasai reveal illegal drug manufacturing by Gaharwar Pharma, seizing items worth Rs. 1.41 crore; investigation ongoing.
AbbVie submits applications to FDA and EMA for upadacitinib approval to treat adult patients with giant cell arteritis.
Merck acquires EyeBio, enhancing its pipeline with Restoret™ for retinal diseases, entering pivotal trials in 2024.
Alembic receives USFDA tentative approval for Selexipag Injection, 1,800 mcg/vial, treating PAH to delay disease progression.
Federal court dismisses Boehringer Ingelheim's challenge to Medicare Drug Price Negotiation, upholding Biden administration's policy.
Senate passes Affordable Prescriptions for Patients Act to limit patent barriers, boosting biosimilars and generics.
USFDA inspection clears Piramal Pharma's Ahmedabad site, boosting FDA-approved clinical and commercial batch services.
Curi RMB and Oasis challenge Taisho Pharma buyout in court, arguing the tender offer undervalues the shares.
Moderna and Mitsubishi Tanabe partner to co-promote mRNA respiratory vaccines, including Spikevax, in Japan till 2029.
Daewoong Pharmaceutical's Nabota, now approved in Argentina as Clodew, is the first Korean BTX product to enter the market, set for Q4 launch.
Recce Pharmaceuticals Ltd received a $2M grant from the U.S. Dept. of Defense to develop RECCE 327 Gel for treating military burn wound infections.
Medicus Pharma updates FDA with non-invasive basal cell carcinoma treatment using doxorubicin micro-needle arrays in Phase 2 protocol submission.
MIRA Pharmaceuticals, Inc. reports preclinical results for MIRA-55, an innovative oral marijuana analog, showing potential to treat anxiety & cognitive decline.
GC Cell and Checkpoint Therapeutics unite to synergize cosibelimab and Immuncell-LC in groundbreaking cancer therapies.
Heron Therapeutics celebrates CMS's 2025 Non-Opioid Policy inclusion of ZYNRELEF® for post-surgery pain relief, aiming to reduce opioid use.
Lupin sells US women's health business to Evofem Biosciences, focusing on respiratory and neurological diseases.
India tightens Schedule G drug ad rules to curb misleading promotions. Public feedback invited on draft changes to the Drugs and Cosmetics Rules, 1945.
Silo Pharma acquires exclusive global license for SPC-14, targeting Alzheimer's, leveraging FDA's 505(b)(2) pathway.
Legend Biotech, known for its CAR-T therapy, evaluates takeover bid; J&J speculated as potential acquirer.
Emmaus Life Sciences achieves FDA compliance success, ensuring drug safety and quality with top inspection results.
Supreme Court supports NPPA's recovery of Rs 4.65 crore from Sun Pharma for violating DPCO pricing on Roscilox.
Sumitomo Pharma's DSP-5336, targeting AML with KMT2A rearrangement or NPM1 mutation, earns FDA Fast Track with strong clinical results.
FDA rejection of Hengrui's camrelizumab cites facility issues; resubmission planned, reinspection needed for approval.
SPI Pharma and Inimmune team up to create and commercialize innovative adjuvant systems, enhancing vaccine efficacy.
OMERS acquires Aclaris's future royalty payments from Lilly's OLUMIANT sales for alopecia areata, paying $26.5M.
Johnson & Johnson to pay $505M to settle disputes with talc suppliers, resolving ongoing conflicts amid talc cancer lawsuits.
Genomics plc and Vertex Pharmaceuticals renew collaboration for three more years, leveraging human genetics and AI to advance precise healthcare solutions.
Kindeva Drug Delivery's Woodbury, MN facility achieves FDA VAI status, ensuring top-tier analytical services for pharmaceuticals and medical devices.
Sionna Therapeutics acquires global rights from AbbVie to develop cystic fibrosis treatments galicaftor, navocaftor, and ABBV-2851, advancing CF care.
Upperton Pharma Solutions secures MHRA approval for a new 50,000 sq ft GMP facility in Nottingham, enhancing oral, nasal, and pulmonary drug production.
The FDA warns Cadila Pharmaceuticals Ltd for CGMP lapses at its Ankleshwar plant, risking US export license. Urgent corrective measures required within 15 days.
ICER warns Verona Pharma's $2,950/month COPD drug Ohtuvayre may face access barriers due to high cost.
Corden Pharma invests €900M to enhance peptide production capacity, addressing diabetic drug shortages.
Glenmark gains FDA approval for Topiramate Capsules, enhancing its US portfolio with Janssen's Topamax® equivalents.
Seers' mobiCARE, a 19g device, offers 9-day ECG monitoring, improving early heart disease detection using AI.
Zensar Technologies acquires BridgeView Lifesciences for $25M, boosting healthcare and life sciences offerings.
Sanofi plans €400M investment in Hyderabad, India, increasing its global capacity centre workforce to 2,600.
GC Biopharma sells Hong Kong subsidiary to CR Pharmaceutical for 350B won, boosting financial stability and exports.
Kintor pivots to cosmetic market with KX-826 hair loss treatment after clinical trial failures to boost revenue.
Endo USA recalls clonazepam tablets due to labeling error. Cartons incorrectly state 0.125mg instead of 0.25mg, though blister packs are correct.
Acurx Pharmaceuticals secures a new patent for ibezapolstat, targeting C. difficile infection, enhancing gut health, with Phase 3 trials upcoming.
Dermata Therapeutics reaches halfway in Phase 3 trial for DMT310, a once-weekly acne treatment. Topline data expected Q1 2025.
Scorpius Holdings Inc. completes initial cGMP microbial batches at San Antonio, marking a pivotal step in clinical manufacturing with strong client interest.
Phathom’s VOQUEZNA gains FDA approval for Non-Erosive GERD, offering novel 24-hour heartburn relief.
Med journal publishes LILAC studies showing DAYBUE improves Rett syndrome symptoms with a consistent safety profile.
Silo Pharma and Resyca BV partner on nasal spray tech for SPC-15, enhancing brain delivery for PTSD treatment.
Zuellig Pharma & Institut AllergoSan Forge Decade-Long Partnership to Boost Probiotic Brand OMNi-BiOTiC® in Asia's Growing Market.
Teva’s Phase 3 SPACE study shows AJOVY (fremanezumab) effectively prevents migraines in kids and teens, with a safe profile and no new concerns.
GSK's Blenrep MAA for relapsed/refractory multiple myeloma, combined with BorDex or PomDex, is accepted by EMA. CHMP review underway for potential approval.
Jonjo O'Neill Racing has secured a sponsorship deal with Wasdell Group, Europe's largest independent contract packer and a rising star in pharma manufacturing.
Daewoong Bio banned from China's VBP due to manufacturing errors; cefodizime sodium supply affected.
60 Degrees Pharmaceuticals Begins Clinical Trials for Tafenoquine to Treat Babesiosis in Partnership with Top Medical Centers.
Capra Biosciences wins $7.5M project to scale U.S. biomanufacturing of APIs, enhancing domestic production and addressing supply chain issues.
SemaPhore™ nanoparticles deliver SOD2 mRNA to treat AAA, lowering aortic dilation, rupture risk, and boosting survival.
Shuttle Pharma's HDAC inhibitor SP-1-303 shows potential in inhibiting estrogen receptor positive breast cancer growth.
EMA validates Opdivo + Yervoy as first-line treatment for advanced HCC, with significant OS improvement in CheckMate -9DW trial.
Athenahealth completes UDS+ synthetic testing, enhancing FQHC support with streamlined data submission and improved patient outcomes via advanced technology.
LEO Pharma’s delgocitinib cream trial results featured in The Lancet, marking a milestone for new treatments in chronic hand eczema.
Boehringer Ingelheim launches a Humira biosimilar at 92% off, priced at $550 via GoodRx, aiming to boost access and market share.
EMA accepts Ono Pharma's MAA for vimseltinib to treat TGCT, following $2.4B Deciphera acquisition, eyeing $1B sales.
Medicamen Organics partners with Depot Pharmacy Yego, investing $75K to launch operations in Rwanda, leveraging Kigali's strategic location and tax benefits.
Ayesha T. Haq calls for policy reforms to address regulatory and economic barriers for pharma MNCs in Pakistan.
Lupin's U.S. partner, ForDoz Pharma, secures FDA approval for generic Doxorubicin Hydrochloride Liposome Injection, targeting ovarian cancer and more.
TME Pharma Unveils Strategy to Outsource and Capitalize on NOX-E36 for Ophthalmic Diseases, Citing Strong Clinical Potential and Market Opportunity.
Addex Therapeutics confirms Janssen halts ADX71149 epilepsy development after Phase 2 results but will continue data analysis and collaboration efforts.
Meitheal Pharmaceuticals acquires North American rights to CONTEPO for drug-resistant UTIs, with FDA decision expected in 2024.
Traws Pharma appoints KPMG LLP as its new independent accounting firm, effective December 2024, after no disputes with previous auditor Ernst & Young.
STADA and Alvotech launch Uzpruvo® in Europe, the first Stelara® biosimilar, enhancing access for Crohn's disease and psoriasis patients.
Tobinco’s Lufart wins Best Pharmaceutical Product at Ghana International Products Event, showcasing local innovation in healthcare.
RADIAN to fund HIV initiatives in EECA, extending aid to Ukrainian refugees, improving access to vital services.
Chugai transfers MONILAC Syrup rights to Maruishi, including manufacturing and marketing permissions, to optimize the product's value.
MIRA's Ketamir-2, a novel oral ketamine analogue, shows potential for treating neurological conditions with enhanced absorption.
Aligos and Amoytop partner on a Phase 1b trial to evaluate ALG-000184 and PEGBING® for chronic hepatitis B treatment.
SynaptixBio extends collaboration with Evotec to develop new ASO drug candidates for TUBB4A leukodystrophy treatment.
Agilent Technologies to acquire BIOVECTRA for $925M, expanding capabilities in biologics and accelerating drug development. Deal expected to close before 2025.
Kobayashi Pharmaceutical’s chairman and president resign amid scrutiny over red yeast rice supplement linked to health issues and disclosure delays.
Hikma expands acetaminophen injection recall to include consumers due to possible dexmedetomidine mix-up, posing serious health risks.
aTyr Pharma completes Phase 3 EFZO-FIT™ trial enrollment for efzofitimod in pulmonary sarcoidosis. Results expected in Q3 2025, marking a key milestone.
Cytoki Pharma's CK-0045 demonstrates positive Phase 1 results in reducing obesity and type 2 diabetes markers.
MidEuropa will acquire a majority stake in Famar, a pharmaceutical CDMO, to support its growth and expansion, with the deal expected to close in late 2024.
Mayne Pharma sues Sun Pharma over patent infringement on menopause treatment IMVEXXY, triggering a 30-month FDA stay.
Autobahn Labs and Charles River collaborate to advance early-stage therapeutics, with Charles River joining as an investor.
Scorpius to launch its first cGMP mammalian manufacturing campaign at San Antonio facility in Q3 2024, expanding biopharma.
Alcami expands Garner facility, enhancing storage for vaccines and biopharmaceuticals, and creating new jobs.
Tonix receives $34M from DoD for developing a broad-spectrum antiviral targeting CD45 protein over five years.
FDA expands BioMarin's BRINEURA approval to treat all ages with CLN2 disease, based on new clinical trial data.
FDA doubts AstraZeneca's Imfinzi efficacy and safety for lung cancer, with pivotal trial results and overtreatment risks.
Carbogen Amcis triumphs in FDA inspections, with spotless reports for Neuland and Aarau facilities, reinforcing excellence.
Novo Nordisk is building a $4.1B aseptic production plant in Clayton, NC, adding 1,000 jobs and boosting output by 2029.
Mankind Pharma is in advanced talks to acquire Bharat Serums for $1.5B; deal could be finalized soon.
SPI Pharma's ValensTM brand launches, uniting products for vaccines, biologics, and parenteral dosage forms.
Gland Pharma's Hyderabad site gets 2 procedural observations in surprise US FDA inspection, plans remedies.
Sun Pharma's LEQSELVI gets FDA nod for treating severe alopecia areata in adults, offering new hope.
Cue Biopharma refocuses on autoimmune programs, cutting costs and staff to extend cash runway to mid-2025.
Catalyst partners with Kye Pharmaceuticals to bring AGAMREE, a novel DMD treatment, to the Canadian market.
Summit Therapeutics and MD Anderson join forces for a five-year partnership to develop ivonescimab for cancer.
Windtree updates on istaroxime's clinical progress, with Phase 2 results expected soon and new studies planned.
Biopharma Q2 2024 earnings strong; drug price negotiations under the Inflation Reduction Act progressing with limited impact.
EU rejects Eisai and Biogen's Alzheimer's drug Leqembi due to serious brain swelling risks and limited trial benefits.
Biopharma company delists from OTCQB due to low volume, continues trading on London Stock Exchange's AIM Market.
SFV drum pump provides efficient fluid transmission for various needs, with material choices, connections, and motor options.
FDA authorizes LIVMARLI label expansion for cholestatic pruritus in PFIC patients aged 12 months and older.
JSR Life Sciences' KBI Biopharma extends a $250M manufacturing deal with a global pharma partner, committing to produce two therapeutic products through 2029.
Checkpoint Therapeutics' cosibelimab BLA for cSCC accepted by FDA for review, with a PDUFA goal date of Dec 28, 2024, after resubmission resolves prior concerns
QuVa Pharma acquires LogicStream, integrating predictive analytics to tackle drug shortages and improve pharmacy operations.
Kobayashi Pharmaceutical didn't report certain items to the health ministry; instructed to submit a report by Wednesday.
FDA grants Orphan Drug and Rare Pediatric Disease status to Cellectis' UCART22 for treating Acute Lymphoblastic Leukemia.
Abbott ordered to pay $495M after jury finds specialized formula caused NEC in preterm infants, leading to lawsuit.
A dengue prevention initiative by Takeda and USAID, educating communities in Maharashtra, Odisha, and Uttar Pradesh on disease prevention.
New $20M pharmaceutical plant opens in Kabul, adhering to WHO standards, promoting local manufacturing and reducing imports.
Daewoong's Versiporosin safe in Phase 2 IPF trials; IDMC final review in 2025 for unique collagen inhibitor.
Schrödinger launches a new initiative to enhance its platform for assessing toxicology risks in early drug discovery, backed by a $10M Gates Foundation grant.
Pharmaceutical Society of Kenya opposes a bill to exclude miraa's psychoactive elements from regulation, warning of health risks & international law violations.
Mauritius' antitrust office investigates potential price-fixing by pharmaceutical importers and wholesalers, affecting drug prices.
Novalead Pharma launches Esmolol-based DFU gel post-Indian approval, aims for global market with further trials.
Paratek's Nuzyra, Phase III study for CABP shows safety, efficacy, and non-inferiority to moxifloxacin, paving the way for broader applications.
Fiocruz partners with University of Coimbra to develop radiopharmaceuticals and register medicines in Brazil and Portugal, enhancing tech transfer and public health access.
HLS Therapeutics and Alberta Health finalize PLA for Vascepa reimbursement in cardiovascular disease treatment.
Cyclo Therapeutics receives European patent for Alzheimer's treatment method, effective August 21, 2024, enhancing their patent estate.
Boehringer Ingelheim acquires Nerio Therapeutics up to $1.3B, enhancing its immuno-oncology portfolio with innovative PTPN1/2 inhibitors for cancer treatment.
Eli Lilly launches a powerful Olympic campaign with Team USA, urging everyone to fight for their health and embrace the uniqueness of their bodies.
Calliditas Therapeutics Secures Full EU Marketing Authorization for Kinpeygo, Expanding Treatment Access for IgAN Patients.
Roche acquires LumiraDx's point-of-care tech, enhancing decentralized diagnostics, global healthcare access, and molecular testing.
GSK partners with Flagship Pioneering to develop transformative drugs and vaccines in immunology and respiratory treatments.
Amneal Pharmaceuticals gains FDA approval for potassium phosphates IV bags, simplifying hypophosphatemia treatment ready-to-use, preservative-free injections.
Celldex Therapeutics announces positive topline results from its Phase 2 trial of barzolvolimab, a promising treatment for chronic inducible urticaria.
GSK and Ronald Kimbrow settle lawsuit with GSK denying guilt. Scientific studies find no cancer risk from ranitidine.
Cytiva's Supor Prime filters enhance high-concentration biologic production, lowering blockages and minimizing product loss.
Icure signs with UITC to export Ketoprofen Plaster for joint pain relief. Expands global reach with contracts in Latin America, the U.K., and the UAE.
Waters Corp. launches TA Instruments RS-DSC, a high-throughput DSC for precise thermal stability testing of high-concentration biologic formulations.
Genzyme sues Sarepta for infringing viral vector patents, seeks damages and a jury trial over Elevidys production.
Vertex's suzetrigine NDA accepted by FDA, potentially the first new acute pain treatment in 20 years. Priority review, PDUFA date set for Jan 30, 2025.
CinFina Pharma launches Phase 1 MAD trial for CIN-110, a promising PYY3-36 analog, to assess its safety, tolerability, and effectiveness in treating obesity.
Eli Lilly pledges $5,000 per Team USA record/medal to health equality groups, could donate over $1M during Olympics.
CNS Pharmaceuticals announces an exclusive licensing deal for TPI 287 to advance treatments for brain cancer. Join the webcast on July 30 for insights.
NeuroBo Pharmaceuticals has signed an exclusive license with MThera Pharma for NB-01, aimed at treating painful diabetic neuropathy in clinical trials.
Jacobs secures a contract to upgrade Onondaga County's sewer system using innovative management and Digital OneWater solutions.
Botanix's SofdraTM approved by FDA for axillary hyperhidrosis; $70M secured, launch starts Q3 2024 with digital release in Q4.
Telix's TLX250-CDx BLA faces FDA sterility issue; resubmission in 90 days, no change to 2024 forecast.
Celltrion Inc. gains Health Canada approval for its biosimilar Steqeyma, targeting autoimmune diseases, marking its entry into the North American market.
Chugai secures exclusive rights for inavolisib, a PI3K alpha inhibitor for advanced HR-positive, HER2-negative breast cancer, in a deal with Roche.
Adial Pharmaceuticals files a new patent for AD04, aiming to protect its lead treatment for AUD until 2044.
The FDA grants RPDD to Theriva Biologics' VCN-01 for retinoblastoma, enhancing treatment development for this rare cancer.
Tonix Pharmaceuticals highlights NASEM's Long COVID definition linking fibromyalgia to SARS-CoV-2, expanding the market potential for its drug Tonmya.
Contineum Therapeutics' PIPE-307, an M1 receptor antagonist for RRMS, shows positive preclinical data and enters Phase 2 trials.
AbCellera and Lilly expand partnership to develop therapeutic antibodies for immunology, neurology, and cardiovascular diseases.
Sound Pharmaceuticals completes Phase 3 trial for SPI-1005, a groundbreaking treatment for Meniere’s Disease, improving hearing loss and tinnitus.
Johnson & Johnson's DARZALEX FASPRO® gains FDA approval for a new quadruplet therapy, expanding treatment options for newly diagnosed multiple myeloma patients.
CHMP Recommends Approval for Amivantamab with Chemotherapy for Advanced NSCLC, Reduces Disease Progression by 52%.
Medicilon and Hengrui Pharma partner to advance preclinical drug assessments, boosting innovation in China's pharmaceutical sector.
MedPharm and Tergus Pharma merge to enhance CDMO capabilities in topical pharmaceuticals, boosting scientific expertise and production efficiency.
Otsuka Pharmaceutical plans to acquire Jnana Therapeutics for over $1 billion, aiming to enhance its drug pipeline and research capabilities in Boston.
CereMark Pharma and Hall of Fame Health partner for Phase 3 study of Alzheimer's and CTE diagnostic agent.
Jagat Pharma introduces Isotine Eye Gummies to support eye health and combat digital strain for all ages.
Halia Therapeutics and Biolexis use AI to identify a promising treatment targeting NLRP3-driven neuroinflammation for Parkinson’s and neurodegenerative diseases
First patient dosed in Phase 3 trial comparing ifinatamab deruxtecan to standard chemotherapy for relapsed SCLC.
Chugai's Alecensa gets Taiwan TFDA approval for adjuvant treatment in ALK-positive NSCLC post-tumor removal.
Vectura Fertin Pharma and Aurora partner to launch new CBD lozenge on Aurora's Canadian medical cannabis platform for patient feedback.
MilliporeSigma acquires Mirus Bio for $600M, bolstering its viral vector production solutions for gene therapies.
BioIVT partners with Germfree to launch a state-of-the-art cleanroom facility in Winchester, VA, enhancing support for cell and gene therapy.
SMS Pharmaceuticals and Sri Avantika Contractors plan a $200M investment in a pharmaceutical park in Vietnam, aiming for $4-5B in additional investments.
Regeneron’s Eylea sales surged to $304M in Q2, revitalizing its franchise despite competition and FDA delays for linvoseltamab.
Merck explores combining Keytruda with RNA-based vaccines alongside Moderna to enhance melanoma treatment options before the drug's patent expiration in 2030.
Sanofi and Vir sign exclusive deal for masked T-cell engagers to target cancer and infectious diseases.
Calls grow for Gilead to reduce lenacapavir price for HIV prevention, highlighting disparity in global drug access.
Alembic Pharma gets US FDA nod for Nelarabine Injection, used for T-cell leukemia/lymphoma, marking its 211th ANDA approval. Market size: $23M.
AMX0035, designated as an orphan drug, improves glycaemic control and vision in Wolfram syndrome patients.
JAMP Pharma recalls digoxin pills for potential misdosing. Patients should consult their pharmacist immediately.
CDSCO and SDCs enforce drug quality laws, inspecting 400 facilities and taking over 300 actions against violations.
FDA grants fast-tracked approval to Tecelra for treating synovial sarcoma, marking a key milestone for Adaptimmune.
Zevra Therapeutics gets FDA GeMDAC's backing (11-5) on arimoclomol for Niemann-Pick disease type C. FDA decision due by September 21, 2024.
SCHOTT Pharma unveils a 160-syringe nest for prefillable syringes, boosting efficiency by 67%, cutting costs, and reducing carbon footprint by 17%.
Freudenberg Medical Expands Biopharma Line with Custom Single-Use Assemblies for Protein Production and Bioprocessing.
Sanofi plans to invest €1.3bn in a new insulin facility in Frankfurt by 2029, supported by German government initiatives to strengthen pharma production.
PA Governor invests $3M in Adare Pharma's $16.8M expansion, creating 115 jobs, relocating HQ to Philly, and boosting the state's life sciences hub.
Vietnam's $7B pharmaceutical market faces infrastructure and financial challenges, yet shows 7.3% annual growth, aiming to be a regional hub by 2030.
Dr. Jaideep Gogtay of Cipla highlights the urgent need for enhanced surveillance and drug discovery to combat Antimicrobial Resistance (AMR) in India.
Court dismisses drug manufacturers' IRA price-setting challenges; Novo Nordisk plans appeal, others continue objections.
UP Manila develops E-Tox POCT kits for detecting poisoning drugs and NPS, filling a critical emergency need.
CordenPharma invests €900M ($981M) to boost GLP-1 peptide manufacturing in Europe and the US, aiming for €1B sales by 2028. Largest investment in 18 years.
Attendees experienced a heartfelt documentary that honoured Dr. KH Sancheti's journey, highlighting his commitment to affordable healthcare and patient care.
Ono Pharmaceutical partners with Monash University to develop new anti-GPCR antibodies, aiming to create treatments for autoimmune and inflammatory diseases.
Eli Lilly and Novo Nordisk race to meet high demand for GLP-1 weight-loss drugs, aiming to supply a market projected to reach $150 billion by the early 2030s.
DKSH partners with Kyowa Kirin to enhance healthcare access across Asia-Pacific, promoting established medicines and driving sustainable growth in the region.
FDA accepts LK's JLK-CTP application. Korean AI firm aggressively pursuing U.S. market for stroke diagnostic solutions.
Formosa Pharma partners with Apotex to market APP13007 in Canada for post-op eye inflammation relief.
Kakao Healthcare's research alliance with top hospitals aims to revolutionize global healthcare through AI and big data.
Destiny Pharma to present data at IPS 2024 showing XF-73 reduces MRSA in burn wounds by 99.99% and prevents sepsis, a breakthrough in infection control.
Biotech startup Ribon Therapeutics ceased operations in 2024, auctioning its assets, including PARP inhibitors.
Rznomics and SK pharmteco sign a multi-year MOU to develop and market RNA-based gene therapy products.
Agenus regains AGEN1777 after Bristol Myers cancels a $1B cancer immunotherapy deal amid strategic realignment.
BioMarin refocuses ROCTAVIAN® on the U.S., Germany, and Italy, cutting costs to $60M by 2025 for severe hemophilia A.
Asymchem opens a new European facility in Kent, U.K., to boost R&D and manufacturing with advanced, sustainable technologies.
The FDA rejects Telix Pharmaceuticals' TLX250-CDx PET imaging agent for kidney cancer due to sterility concerns, though approval is still anticipated.
WCG acquires Array to enhance clinical research training, improving efficiency, safety, and outcomes through innovative engagement and data insights.
Lantern Pharma's AI-driven HARMONIC™ phase 2 trial of LP-300 with chemotherapy shows promising safety and efficacy in NSCLC patients post-TKI treatment.
Yaskawa and Astellas partner to enhance cell therapy production, bridging research to commercialization efficiently.
Quoin Pharmaceuticals starts a New Zealand trial for QRX003, aiming to treat Peeling Skin Syndrome in children.
Lupin's Phase 3 trial of LUBT010, a biosimilar to Lucentis, shows therapeutic equivalency in treating wet AMD.
Celltrion's Zymfentra, a subcutaneous infliximab, joins major US PBM insurance lists after March launch.
CereMark Pharma's Phase III trial will investigate F-18 flornaptitril, targeting proteins in Alzheimer's and CTE.
Henrietta Lacks' family sues Novartis and Viatris for profiting from HeLa cells taken without consent in 1951, seeking justice and restitution.
Cloudbreak Pharma partners with Santen Pharmaceutical to develop CBT-001 in Southeast Asia, while preparing for a Hong Kong listing amid rising losses.
Sangamo and Genentech collaborate on gene therapies for neurological diseases, aiming to tackle conditions like Alzheimer's.
Reviva Pharmaceuticals secures USPTO patent for brilaroxazine, enhancing IP for treating lung diseases including IPF and COPD.
Daiichi Sankyo and Merck expand global partnership to develop MK-6070, a DLL3-targeting therapy for neuroendocrine tumors and SCLC.
Nestlé Health Science acquires Seres' VOWST, funding Seres' pipeline and improving outcomes for fragile patient groups.
NeuroBo Pharmaceuticals, partnering with Dong-A ST and ImmunoForge, is developing a long-acting, once-monthly version of DA-1726, targeting obesity treatment.
Tonix Pharmaceuticals announces a new publication on COVID-19 convalescent sera screening in "Microorganisms," highlighting their advanced imaging technology.
Compass Therapeutics enrolls 150 patients in the COMPANION-002 trial to assess CTX-009 for BTC. New IST approved at MD Anderson for first-line treatment.
Cadrenal Therapeutics is in talks with Abbott for a tecarfarin study in LVAD patients, aiming to enhance anticoagulation and prevent strokes.
Roche, Chugai sign agreement for RG6631, an anti-TL1A antibody for Crohn's and ulcerative colitis treatment in Japan.
WHO alert, Counterfeit Oxymorphone Hydrochloride 40mg tablets found in Finland. Contains dangerous metonitazene, report adverse effects to authorities.
Shanton Pharma has completed enrollment for its Phase 2b trial of SAP-001, targeting refractory gout patients, with topline data expected in Q1 2025.
Aurobindo Pharma Receives USFDA Approval for Estradiol Inserts, Reaches 521 ANDA Approvals, Reports 79.5% Profit Increase in Q4 FY24.
Vertex, NHS England provide gene therapy for beta thalassaemia; CASGEVY approved by UK MHRA and NICE.
FDA approves Purdue Pharma's Zurnai auto-injector for opioid overdose, treating adults and children 12+.
Formosa and Eyenovia team up to develop Clobetasol Propionate for dry eye, leveraging advanced nanoparticle technology.
Pharmacosmos acquires G1 Therapeutics for $405M, enhancing COSELA's reach for lung cancer patients, benefiting stakeholders.
Abbott and Medtronic team up to create an integrated CGM system, enhancing diabetes management with automated insulin delivery.
Adial Pharmaceuticals completes dosing for AD04 study targeting Alcohol Use Disorder, with top-line results expected in Q4 2024.
Agenus Inc. unveils a study on botensilimab, a novel anti-CTLA-4 antibody, showing efficacy in resistant cancers, transforming the tumor microenvironment.
Silo Pharma partners with WuXi AppTec to study SPU-16 peptide for MS treatment, leveraging CNS targeting for enhanced drug delivery and reduced toxicity.
Lonza boosts Bend, Oregon facility for clinical bottling, enhancing early-phase trial efficiency and product delivery.
Mallinckrodt launches the Acthar Gel SelfJect™ Injector, a user-friendly option for patients with chronic inflammatory and autoimmune conditions.
Samsung Biologics becomes the first Korean CDMO to join the PSCI, committing to sustainable practices and enhancing its ESG efforts in global healthcare.
CVC Capital Partners agrees to acquire Mallinckrodt's Therakos division for $925 million, aiming to enhance its global reach in immune-related therapies.
FDA approves CREXONT, a new CD/LD formulation for Parkinson's, offering longer "Good On" time with fewer doses.
Conduit Pharmaceuticals and AstraZeneca partner to advance AZD5904, AZD1656, and AZD5658 for autoimmune diseases and infertility in Phase II trials.
Iris Acquisition Corp is progressing with its merger plans with Liminatus Pharma, filing an amended Form S-4 and securing a Nasdaq listing extension.
Merck terminates Phase 3 KeyVibe-008 trial for small cell lung cancer due to failure to meet survival endpoints and increased adverse events.
Apellis Pharmaceuticals and Sobi reveal promising Phase 3 VALIANT study results, showing pegcetacoplan's potential for C3G and IC-MPGN.
USSF invests $15M to expand its Lehigh Valley biopharma facility, boosting clean room capacity and creating 100+ jobs, enhancing its pharmaceutical services.
Merck acquires CN201 for $700M with up to $600M in milestones, targeting B-cell disorders; closing in Q3 2024.
FDA approves Neffy, the first needle-free epinephrine for severe allergies, improving patient care and outcomes.
Vivint Pharma invests $48M in Hyderabad facility, creating 1,000 jobs to produce injectables for critical care and cancer.
Angiex begins Phase 1 trial dosing for AGX101, an innovative TM4SF1-directed ADC targeting solid tumors.
Novartis' Fabhalta gets FDA approval for IgAN, targeting complement system to reduce proteinuria in kidney disease.
Meiji Seika Pharma Co., Ltd. opens a new Boston office, its venture into life sciences investments to develop innovative therapies for global health needs.
Oncimmune wins $1.5M contract with major pharma, expects FY24 revenue of £3.0M and profitability by FY25.
Granules India secures FDA approval for trazodone tablets, enters $128M U.S. market with expected strong growth.
India's pharma industry highlights HVAC's vital role in ensuring product quality, worker safety, and regulatory compliance.
LTS and GRAMME team up to provide pharma firms with turnkey solutions for biologic drug delivery and market access.
FDA charges BMS with fabricating data on Krazati's effectiveness for KRAS cancer, challenging trial findings.
Recursion buys Exscientia for $688M, expanding AI-based drug development pipeline and forming new pharma alliances.
Merck's Aarogya program, launched in Patalganga, Raigad, offers health screenings, diagnostics, and awareness, impacting 800+ lives with comprehensive care.
Chifu and CTC BIO sign exclusive deal to distribute One-two Tab in Taiwan, with plans for global expansion.
GC MS signs a $2.9M export deal with Hong Kong's Firstlink Healthcare for Gcare Lipid devices, expanding its global reach in diagnostic technology.
Tobinco Pharmaceuticals cleared by Accra High Court, FDA allegations of counterfeit drug importation dismissed. Legal victory announced August 2024.
FDA issues CRL for Lykos Therapeutics' PTSD drug, citing safety concerns; requests more Phase III trials.
Atul Bioscience receives FDA EIR for Ambernath plant, with zero findings after successful May 2024 inspection.
GC Biopharma's GC1130A for Sanfilippo syndrome gets Japan PMDA approval for phase 1 trial, following U.S. and Korea approvals.
Marker Therapeutics receives $2M NIH grant to study MT-601 for relapsed non-Hodgkin's lymphoma post CAR-T therapy.
LENZ Therapeutics files NDA with FDA for LNZ100, showing promise in Phase 3 for presbyopia treatment.
Wave Life Sciences' WVE-N531, targeting Duchenne muscular dystrophy, receives FDA Rare Pediatric Disease designation.
Breas Medical recalls 8,186 Vivo 45 LS ventilators due to potential formaldehyde exposure, impacting units distributed between Feb 2021 and July 2024.
Pneuma Systems' PneumaFlow Controller joins the FDA's Safer Technologies Program, enhancing infusion safety and streamlining patient care.
60 Degrees Pharma grants the University of Kentucky FDA reference rights for ARAKODA®, advancing a Phase IIb study on malaria treatment with SJ733.
Ascendis Pharma's YORVIPATH gains FDA approval for hypoparathyroidism, offering a once-daily treatment option for patients.
Syros Pharmaceuticals halts patient enrollment in SELECT-AML-1 Phase 2 trial after interim results show no superiority of triplet therapy for AML treatment.
Astria Therapeutics Partners with Ypsomed to Develop Autoinjector for STAR-0215, Offering Patients Flexible, Low-Burden Administration Options.
Daiichi Sankyo's ENHERTU® gains conditional approval in China for advanced HER2+ gastric/GEJ adenocarcinoma.
Blue Earth Therapeutics expands its partnership with Seibersdorf Labor to produce 225Ac-based radioligand therapy for clinical trials in the UK, EU, and U.S.
Taiwan Bio Therapeutics and TRACT Therapeutics advance TregCel technology transfer, setting the stage for a global Phase 2 trial in kidney transplant patients.
Celltrion's Yuflyma biosimilar is now available at Costco, offering uninsured members significant discounts on this crucial medication for chronic conditions.
CMS assigns Abeona's pz-cel gene therapy a specific procedure code, enhancing hospital billing and reimbursement for RDEB.
Florida's Grant Cancer Centre first in U.S. to use Accuray Radixact® System with VitalHoldTM, boosting cancer treatment precision.
NeuroBo completes enrollment for Phase 1 trial of DA-1726, a dual agonist for obesity with superior pre-clinical results.
Boudicca Dx and Adial partner to develop a companion diagnostic for AD04, a precision treatment for alcohol use disorder.
Kiromic's KB-GDT-01 (Deltacel) therapy shows promising PFS results in NSCLC patients in the Deltacel-01 trial, with no dose-limiting toxicities observed.
Galderma's Nemluvio receives FDA clearance for prurigo nodularis, aiming to ease severe itching and skin nodules. Blockbuster potential in dermatology.
Baxter shifts strategy by planning to sell Vantive to Carlyle, aiming to enhance shareholder value and focus on growth, marking a pivotal transformation.
Medtronic's brain modulation division reports low double-digit growth, boosted by Percept RC demand and new asleep DBS approval, enhancing its competitive edge.
Rivus' HU6 shows promise in Phase 2a trial for obesity-related heart failure, achieving key weight loss goals.
Kerato partners with the University of Montreal to develop an innovative corneal treatment, aiming to simplify procedures and improve patient outcomes.
Medison Pharma expands its collaboration with Alnylam Pharmaceuticals to enhance access to RNAi therapies across Central and Eastern Europe, Israel, and more.
Alera Pharma, Lobe Sciences’ US subsidiary, focuses on neurology, merging with the Australian branch soon.
AstraZeneca's sBLA for Imfinzi in LS-SCLC has been accepted by the FDA with Priority Review, backed by the ADRIATIC trial's positive survival results.
Nanoform and Takeda partner to develop plasma-derived therapies for rare diseases. Non-GMP nanomaterials will help advance formulations to market by 2025.
Hoth Therapeutics teams with Aronnax to advance HT-KIT, an FDA Orphan Drug for mast cell cancers, refining dosing and trial protocols.
Gilead's Livdelzi (seladelpar) wins FDA accelerated approval for primary biliary cholangitis, showing notable reductions in ALP levels and pruritus.
FDA recalls B. Braun and Baxter sodium chloride batches due to endotoxins, particle leaks, and contamination risks.
Medtronic partners with Abbott to integrate CGM tech into insulin pumps, aiming to revive diabetes care segment.
Cuban-China joint venture prepares China trials for Itolizumab, tech transfer for cancer drugs, and R&D projects.
Abbott's AVEIR DR system enables Canada's first dual chamber leadless pacemaker implants for better heart rhythm care.
Uzbekistan and AstraZeneca explore partnership opportunities for expanding pharmaceutical production and investment.
FDA issues a warning to Aurobindo Pharma's unit after inspection; shares dip amid compliance concerns.
NMPA approves marketing change for Baiyunshan’s Pseudoephedrine and Paracetamol products, boosting its portfolio.
Eli Lilly acquires Morphic Holding to enhance its IBD treatment options with innovative oral integrin therapies.
Bavarian Nordic's Imvanex mpox vaccine seeks EMA approval for teen use, backed by successful Phase II trials.
Sanyou Biopharmaceuticals launches AI-powered oneClick+ platform to accelerate antibody development with advanced design tools and automated analysis.
Novo Nordisk invests 1.5 billion DKK in a Køge facility to boost GLP-1 drug production, marking a key step in their global expansion strategy.
IMBiologics transfers autoimmune tech to Huadong Pharmaceutical in a deal worth up to $375M. Huadong gains rights to develop in Asia, excluding key markets.
NorthStar and Convergent are advancing prostate cancer treatment with CONV01-α, using Ac-225 and a monoclonal antibody.
Nuntius and Taiho partner to boost mRNA cancer therapy with advanced nanocarrier tech. Financials undisclosed.
Hikma Pharmaceuticals extends KLOXXADO® nasal spray’s shelf life to 36 months, doubling naloxone dose per spray.
Inspira Technologies secures AMAR approval for its INSPIRA ART100, advancing extracorporeal membrane oxygenation and cardiopulmonary bypass solutions globally.
SciSparc secures exclusive rights to develop SCI-160 pain therapy, with potential $6M+ in earnings and milestone fees.
Huawei’s Watch D2, now medically certified in China, features advanced blood pressure monitoring. Release and price details are still pending.
Avantor divests clinical services to Audax for $650M to focus on lab and production growth, per CEO Michael Stubblefield.
Dr Reddy’s close to buying Nicotinell from Haleon in a deal worth hundreds of millions, aiming for EU market growth.
Discover advanced cleanroom solutions at CPHI & PMEC India 2024. Explore innovations in modular cleanrooms, HVAC systems, and contamination control.
Control Bionics' NeuroNode gets CMS approval with HCPCS code E2513, securing $4,300 reimbursement and aiding users with severe movement impairments.
Alembic Pharmaceuticals gains USFDA approval for Dabigatran Etexilate Capsules, 110 mg, boosting its ANDA total to 211.
Opaganib reduces HFD-induced weight gain and glucose intolerance, targeting a new pathway for obesity treatment.
EMA review of Breyanzi for relapsed/refractory FL could extend CAR T therapy benefits to high-risk lymphoma patients.
Daewoong's NUCEIVA® Botulinum Toxin Launches in Australia at Aesthetics 2024, Marking Global Expansion and New Opportunities in Aesthetic Treatments.
Tanvex BioPharma USA, Inc. secures FDA approval for NYPOZI™ and BLA acceptance for TX-05, advancing biosimilar innovation for cancer treatment.
FDA lifts partial hold on MediLink's BNT326/YL202 Phase I trial, resuming recruitment with new safety measures and updated protocols.
Visiox Pharmaceuticals merges with Ocuvex Therapeutics to enhance eye care leadership, expanding their product range and market impact.
Oncimmune lands a $1.5M contract to profile IgE autoantibodies, expanding its global pharma partnership. Revenue expected in FY 2025.
Germany faces drug shortages as states halt China inspections due to new espionage laws, risking supply chain disruptions in Europe.
Hyundai Pharm launches Slinda in South Korea through an exclusive deal with ASKA Pharmaceutical, offering a new progestin-only contraceptive option.
Nightingale Health secures additional HSA approval in Singapore for expanded blood tests including fatty acids analysis.
ZOLL® wins bid for Vyaire Medical’s ventilator business, pending court approval, enhancing its respiratory care portfolio.
Regeneron receives CRL for linvoseltamab in R/R MM, awaiting FDA re-inspection after manufacturing concerns.
Marksans Pharma's Goa plant receives EIR from USFDA, inspection classified as Voluntary Action Indicated (VAI).
Granules Pharma’s ANDA for Glycopyrrolate Oral Solution 1mg/5mL, bioequivalent to Cuvposa, accepted by FDA.
Fujifilm Diosynth Biotechnologies expands its facility, tripling production capacity to support specialized treatment for wet age-related macular degeneration.
VGXI Inc. joins the BioMap Consortium, enhancing U.S. biopharmaceutical production with its extensive expertise and leading plasmid DNA capacity.
eXmoor Pharma gains MHRA licence for GMP-grade cell and gene therapies at its new Bristol facility, marking a key milestone in its global expansion
Delhi High Court rules that trademark laws apply to corporate names, overturning Mankind Pharma's case dismissal against Mercykind Pharmaceuticals.
IGC Pharma’s AI suggests IGC-1A may be a GLP-1 agonist, offering growth potential in Alzheimer’s and weight loss markets.
BerGenBio teams with Tempus to advance bemcentinib for NSCLC, leveraging AI for data-driven insights and synthetic controls.
Bora Pharmaceuticals has finalized the acquisition of Emergent BioSolutions' 87,000 sq. ft. sterile manufacturing facility in Camden, Maryland, enhancing its U.S. presence and capabilities in aseptic fill/finish services.
Sigachi Industries launches PureCoat and UltraMod, revolutionary pharmaceutical coatings designed to enhance drug stability, delivery, and bioavailability.
PCI Pharma Services becomes the first CDMO to pass the ICMRA's Collaborative Hybrid Inspection Pilot program at its Bedford, NH site, streamlining global regulatory approvals.
Benuvia to source DEA-approved cannabis and psychedelics from Bright Green for cGMP pharmaceutical APIs.
Touchlight and Nottingham University collaborate on scalable DNA vaccine for Zika, backed by UK Vaccine Network.
Vantedge Medical, backed by Aterian, acquires precision device maker Hobson & Motzer to expand in surgical staplers and enhance manufacturing for top OEMs.
SI-Bone’s TNT Implant earns FDA clearance, offering enhanced fixation and reduced screw backout for pelvic fractures. Designed for sacropelvic anatomy.
Amplitude Vascular Systems partners with Jacobs Institute to test Pulse IVL system for improved coronary and carotid artery treatments and stroke care.
TNF Pharmaceuticals to begin mid-stage trials for MYMD-1, targeting sarcopenia and expanding into autoimmune conditions.
RedHill Biopharma launches Talicia in the UAE to treat H. pylori infections, marking the region’s first low-dose rifabutin therapy.
Tris Pharma initiates Phase 3 trials for cebranopadol, designed to provide opioid-level pain relief with less addiction risk.
ST Pharm signs deal with Gilead, driven by US biosecurity measures, to supply APIs for blockbuster HIV drug Biktarvy.
Troy M. Wagner named VP of Quality Assurance at Tempest Therapeutics, focusing on late-stage oncology candidate amezalpat.
Leo Pharma’s TMB-001 for congenital ichthyosis fails Phase III trial, missing key goals, halting FDA submission plans.
Innocan Pharma’s subsidiary achieves MoCRA compliance, advancing plans for premium cosmetics in the US market.
eXmoor Pharma earns MHRA approval, enabling GMP manufacturing of cell and gene therapies for clinical trials in the UK.
Novartis and Versant launch Borealis Biosciences, advancing kidney disease research with xRNA-based innovations in Canada.
Bridge Biotherapeutics partners with HitGen to fast-track the discovery of novel anticancer drugs, leveraging HitGen's DNA-encoded library technology.
Samjin Pharmaceuticals donates Geworin to underserved communities and disaster zones, boosting global healthcare efforts.
UK approves Leqembi for early-stage Alzheimer’s, but NHS access denied due to high costs and uncertainty over long-term effectiveness.
The FDA is launching a new surveillance system to better track risks of defective medical devices, aiming to prevent injuries and deaths. Launch by Dec 2024.
Alkem MedTech partners with Exactech to manufacture and market joint implants in India, boosting local production and expanding orthopedic access.
PharmaTech Expo 2024 returns in Gujarat, emphasizing pharmaceutical advancements and industry collaboration.
DuPont strengthens medical device capabilities with acquisitions of Donatelle and Spectrum Plastics, enhancing growth.
VION acquires Echelon Biosciences, boosting lipid-based excipients for mRNA therapies and expanding product offerings.
OKYO Pharma’s OK-101 shows promise in Phase 2 trials for dry eye and corneal pain, addressing unmet medical needs.
Altamira expands Bentrio® distribution to Sweden and Denmark via Pharma Nordic, following success in Norway’s market.
Eli Lilly extends partnership with Oblique Therapeutics to discover a second antibody using AbiProt’s epitope technology.
Ingenza and Cellugy team up to advance bacterial cellulose production for bio-based alternatives to petrochemicals.
India’s BioE3 Policy aims to drive biotech growth, innovation, and biomanufacturing jobs through green economy models.
BioIVT acquires ZenBio to enhance biospecimen offerings, expand cell services, and boost support for pharma and cosmetics R&D.
LBT Innovations upgrades APAS® Independence to support 55mm plates, boosting pharmaceutical environmental monitoring capabilities.
Alembic Pharma gets USFDA approval for Betamethasone Valerate Foam, 0.12% for scalp dermatoses. Total 213 ANDAs approved.
Innocan Pharma’s BI Sky Global achieves FDA MoCRA registration, meeting high standards for U.S. cosmetic products.
PPPI aims to partner with PhilHealth to secure medicine supplies for Konsulta and GAMOT programs, with new Botika ng Bayan for distribution.
Orchid Pharma and Cipla launch Cefepime-Enmetazobactam for cUTI, HAP, and VAP, boosting AMR efforts and nationwide distribution in India.
Siemens Healthineers buys Novartis’ AAA diagnostics unit for €200M, enhancing PET scan imaging and market reach.
SurGenTec’s FDA-approved B-MAN Kit enhances bone marrow aspiration with CELLect tech for optimal, contaminant-free results.
The Union Cabinet approves BioE3 policy, boosting India's biomanufacturing with a focus on innovation, sustainability, and net zero emissions by 2070.
Tonix Pharmaceuticals and Bilthoven Biologicals team up to advance TNX-801, a promising mpox vaccine candidate, showing strong preclinical results.
Sana Biotechnology names Dr. Dhaval Patel as EVP & CSO, advancing clinical programs and Type 1 diabetes trials, with a stock target increase.
Regeneron's Ordspono gets EU nod for relapsed or refractory follicular lymphoma and DLBCL, marking its first bispecific.
A new initiative by IFC and The Netherlands aims to strengthen Jordan's pharmaceutical sector, enhancing exports and attracting foreign investments.
FDA approves Moderna and Pfizer mRNA Covid-19 vaccines targeting Omicron KP.2, offering enhanced protection for ages 6 months and up.
Avery Dennison introduces AD Minidose U9XM, a high-memory UHF RFID tag for precise tracking and authentication of small pharmaceutical items.
EyePoint Pharmaceuticals faces new FDA scrutiny over Yutiq manufacturing at its Watertown facility, following a Form 483 and recent warning letter.
OKYO Pharma secures U.S. Patent No. 12,053,501 for OK-101, enhancing dry eye disease treatment and strengthening its IP portfolio.
Sanofi halts flu vaccine distribution in China due to reduced effectiveness concerns. The pause affects Vaxigrip and VaxigripTetra for the 2024-25 season.
Bharat Biotech Launches HILLCHOL Oral Cholera Vaccine to Bridge Global Supply Gap with 200M Dose Production Capacity.
Chinese medical device companies are expanding globally to tackle domestic competition and regulatory hurdles, driving growth.
AIIMS Delhi partners with Osaka University to set up a center in Jhajjar for medical device development under "Make in India.
Pharma Now partners with Indian Vaccine Leaders Conclave 2024, spotlighting vaccine advancements, collaboration, and top achievers.
Explore Cardinal Health's new 8,000-sq-ft Advanced Therapy Innovation Center, offering cutting-edge logistics for cell & gene therapies in Tennessee.
Pharma giants Alkem and Entod seek Delhi HC relief to deplete banned FDC drug stocks, challenging a new government ban on 156 such combinations.
New Mpox variant Clade 1b spreads rapidly from Africa to Europe and Asia, prompting a global health emergency and a $135M funding call by WHO.
GAO audit exposes FDA's challenges in tracking medical device safety, highlighting risks to patient health and well-being
UCSB secures $22M NSF grant to create ExFAB, the first U.S. biofoundry focused on harnessing extreme microbes for innovative biotech solutions.
NSF invests $75M in 5 biofoundries to advance biology, AI, and health, democratizing research access and supporting innovation across diverse fields.
Novartis' Leqvio (inclisiran) shows promise in a Phase III trial, significantly lowering LDL-C levels in ASCVD patients, paving the way for regulatory approval.
Natco Pharma files with the FDA for a generic version of Novartis' Tabrecta, seeking 180 days of exclusivity. Shares drop as Sensex rises.
New PFAS-free method from Amsterdam scientists adds trifluoromethyl groups to drugs, enhancing safety and sustainability.
FDA cites Global Calcium for major production and documentation issues following Tamil Nadu plant inspection.
Pfizer launches PfizerForAll, a direct-to-consumer platform for easier access to treatments like vaccines and migraine therapies.
Irrimax Corporation introduces new kits to extend the use of its IRRISEPT solution, focusing on infection reduction and improved care.
OxiWear's FDA-approved ear-worn pulse oximeter revolutionizes real-time SpO₂ monitoring, enhancing patient care.
AMRA Profiler 4 secures EU MDR certification, paving the way for advanced body composition analysis in Europe.
India's BioE3 policy aims to drive innovation and bio-manufacturing, targeting Rs 25 lakh crore growth by 2030 while promoting a cleaner, greener economy.
FDA clears Cosmo IMD’s GI Genius hardware with ColonPRO AI, enhancing polyp detection and improving colorectal cancer screenings during endoscopy.
Lilly is ramping up GLP-1 production with advanced tech and sustainable practices to meet rising demand and minimize environmental impact.
Torrent Pharma's Indrad facility receives USFDA EIR with VAI classification, ensuring operations and reinforcing its position in regulated markets.
Zydus Lifesciences receives FDA approval for Scopolamine Transdermal System. Production to begin at Matoda facility; product targets nausea and motion sickness.
Sanyou Biopharmaceuticals introduces a new monkeypox product line with 65 items, including antigens, antibodies, and cell lines for diagnostics and research.
WHO urges manufacturers to submit mpox diagnostic tests for emergency use listing as cases rise in Africa, especially in the DRC.
WHO Regional Committee for Africa sets a goal for 55% local production of medicines and vaccines by 2035 to tackle health crises.
Kiyatec’s 3D Predict Glioma test improves survival rates for high-grade glioma patients by predicting chemotherapy response.
DePuy Synthes debuts MatrixSternum chest fixation system, claiming superior strength and reduced procedure time in surgeries.
Tanvex BioPharma secures U.S. FDA approval for Nypozi, a Neupogen biosimilar, and advances its TX-05 BLA for HER2-positive cancer treatment.
Emerging studies suggest semaglutide may offer anti-aging benefits, including reduced mortality and improved metabolic health in overweight individuals with cardiovascular conditions.
Swiss pharma firms, like Novartis, use patent battles to block generics and keep drug prices high, affecting global access and costs.
NXP800 earns FDA Orphan Drug status for ARID1a-deficient ovarian cancers, boosting development and exclusivity.
Servier Korea launches Tibsovo, targeting IDH1 mutation in cholangiocarcinoma and AML, offering new hope for patients with rare cancers.
GSK Boostrix vaccine sales halted due to a packaging defect, affecting two batches with future expiration dates.
Zealand Pharma's DREAM trial reveals dapiglutide reduces weight by up to 4.3% in 12 weeks with good safety and tolerability.
Bayer AG’s Kerendia demonstrates a 16% risk reduction in heart failure complications, boosting growth prospects amid challenges in its pharma division.
FDA warns Eugia Pharma for manufacturing lapses and data issues at its Telangana plant. Corrective actions required.
Biocon Pharma receives USFDA approval for its generic Sacubitril/Valsartan Tablets to treat chronic heart failure.
Cosmo IMD's GI Genius™ boosts polyp detection by 8.3% over standard colonoscopy, as revealed in a new Lancet study, advancing colorectal cancer screening.
GT201, Grit Biotechnology's advanced TIL therapy, secures U.S. FDA IND approval. A breakthrough in solid tumor treatment, powered by proprietary platforms.
Dr. Krishna Ella of Bharat Biotech challenges multinational priorities and media coverage, urging balanced innovation.
Aspivix’s Carevix device receives MHRA approval, advancing gynecology with enhanced patient comfort and care standards in the UK.
FDA authorizes Novavax’s updated COVID-19 vaccine; CDC recommends for individuals 12+ with nationwide distribution soon.
BioPhorum expands with Brookwood Global acquisition, boosting training services in clinical research and life sciences.
Emcure gains court relief from FDC ban, sparking industry debate on the regulation and approval of drug combinations.
Abbott and Medtronic partner to create a diabetes management system, combining FreeStyle Libre CGM with advanced insulin delivery for optimal glucose control.
Johnson & Johnson's nipocalimab aims for FDA approval as a new treatment for generalized myasthenia gravis, showing promising Phase 3 results.
GSK's hepatitis B drug bepirovirsen earns FDA Fast Track status amid a series of promising treatment updates.
Aurobindo Pharma accelerates its specialty portfolio with 14 biosimilars, boosting supply chain efficiency and investing heavily in R&D and biologics.
Explore cutting-edge PNH treatments, including crovalimab and PiaSky, revolutionizing care with new therapies and improving patient outcomes.
The ARC Centre of Excellence in Quantum Biotechnology aims to revolutionize biotechnology and biosciences in Australia.
Entod Pharmaceuticals secures DCGI approval to market PresVu, India's first eye drops for presbyopia treatment
Sareum Holdings obtains US patent for SDC-1801, protecting its innovative autoimmune disease therapy.
Innocan Pharma secures FDA support for expedited approval of its LPT-CBD drug, advancing chronic pain treatment innovation.
Athira Pharma's LIFT-AD study showed fosgonimeton didn't meet primary endpoints but showed promising biomarker and subgroup results.
Zydus Lifesciences receives FDA warning for its Jarod plant after Form 483 citations; plans to address the issues promptly and ensure compliance.
Acepodia teams up with Pfizer Ignite to advance its Nobel-winning cell therapies for cancer and autoimmune diseases, without financial transactions.
Lilly and EVA Pharma partner to locally produce baricitinib, aiming to improve healthcare access in 49 African countries.
Essential Pharma acquires Renaissance Pharma, adding Hu14.18 to its portfolio to address pediatric oncology needs.
Roche's fenebrutinib reveals potential in MS treatment, with positive Phase II extension results presented at ECTRIMS.
Recipharm’s ReciPredict platform applies Quality by Design to accelerate drug development, cut API use by up to 70%, and ensure efficient tech transfers.
Olon plans to acquire HuvePharma Italia Srl and its Garessio facility, boosting production capacity. This expands Olon's presence in Italy and API expertise.
AdvaMed earns ANSI accreditation to set new standards for medical imaging, cybersecurity, and AI, driving innovation in medtech.
MHRA approves Moderna's updated Covid-19 vaccine targeting the JN.1 variant, available via NHS and private purchase for high-risk individuals.
Novartis invests $200M in U.S. radiotherapy with new facilities in California and upgrades in Indiana to boost production and tackle isotope shortages.
EMA's pilot program offers free expert guidance to advance orphan medical devices for rare and pediatric conditions.
The FDA has published a paper on health equity in medical devices, requesting public feedback on key considerations.
Abbott teams up with Beta Bionics to integrate FreeStyle Libre with iLet Bionic Pancreas, streamlining diabetes care.
Paragonix partners with NORA to create a new organ transport service using commercial flights to improve distribution equity.
Astellas opens a new life sciences hub in Massachusetts, featuring a cutting-edge SakuLab to foster biotech innovation and collaboration with 400 employees.
CHECK and RWEAL studies reveal high prevalence of chronic hand eczema in Europe and Canada, stressing the need for better treatments.
Purdue Pharma wins an 18-day extension to continue settlement talks over the Sacklers' role in the opioid crisis, amid criticism and legal scrutiny.
Emcure launches Arth, a range of products focused on easing menopause symptoms and empowering women's health.
Evotec partners with X-Chem to accelerate early drug discovery using DEL technology and advanced data mining tools.
WHO launches guidance to curb antimicrobial resistance by addressing antibiotic pollution from manufacturing waste.
Takeda partners with Sun Pharma and Cipla to commercialize Vonoprazan in India, targeting GERD treatment needs.
Lotus Pharmaceutical acquires Alpha Choay rights from Sanofi in Vietnam & Cambodia, enhancing its anti-inflammatory drug market presence in Southeast Asia.
BlueRock’s OpCT-001 gets FDA IND approval for treating primary photoreceptor diseases. Phase 1/2a trial launching soon.
Novartis CEO Vas Narasimhan announces a $1 billion deal to sell U.S. dermatology and generics divisions to India's Aurobindo Pharma, driving strategic refocus.
NImmune teams up with BioTherapeutics to enhance immunology therapeutics with preclinical and regulatory expertise.
Qiagen and Eli Lilly team up to create an in vitro diagnostic for Alzheimer's detection using APOE genotyping.
Ivonescimab shows significant promise in treating NSCLC, reducing disease progression by 49% over Keytruda.
Firebrick Pharma's Nasodine nasal spray is under review in Europe, with approval anticipated by December 2024.
Sun Pharma and Moebius Medical receive USFDA fast track designation for MM-II, a non-opioid knee osteoarthritis therapy.
Nano4Imaging teams with Arrotek to enhance U.S. production and development of MRI-compatible medical devices.
Suven Pharmaceuticals' share price jumped 3.67% to Rs 1,245 after its Hyderabad facility received a VAI status from the US FDA.
AstraZeneca's new inhalers with a 99.9% eco-friendly propellant mark a major step in cutting greenhouse gas emissions.
Cizzle Biotech partners with Moffitt Cancer Center to test its CIZ1B biomarker for early lung cancer detection.
ProKidney announces strategic updates for rilparencel Phase III trials, targeting faster FDA approval process.
Agilent Technologies launches its Biopharma CDx Services Lab, offering cutting-edge diagnostics and precision medicine solutions for biopharma clinical trials.
Scantox Group acquires UK-based Gentronix, a leader in genetic toxicology, expanding services and global reach in predictive toxicology for drug development.
Newcells Biotech's CiliaBeat software and Lung Ciliary Beat Frequency Assay revolutionize drug testing with precise, predictive insights on ciliary function.
Aptar Pharma partners with PULMOTREE to advance the Kolibri™ Non-Propellant Inhaler, enhancing drug delivery with comprehensive support.
Formosa Pharmaceuticals has shipped its new clobetasol ophthalmic suspension to the US, marking a major step towards its September 2024 launch.
India to locally manufacture Clavulanic Acid and Penicillin G under the PLI scheme, boosting antibiotic production.
GST Council reduces tax on cancer drugs to 5%, enhancing affordability and accessibility for patients across India.
FDA clears Femasys' FemCheck, a diagnostic tool for fallopian tube occlusion, supporting non-surgical birth control.
Abbott rolls out Aveir DR leadless pacemaker in the UK, a dual-chamber system that improves heart rhythm treatment.
Keen Vision Acquisition Corp. and Medera to merge, creating a $622.6M entity focused on gene therapies and Nasdaq listing.
CPHI Milan announces 2024 Pharma Awards finalists, featuring new "Woman of the Year" and "Future Leader" categories celebrating industry innovation.
Roche opens its state-of-the-art pRED Center in Basel, enhancing global R&D collaboration to accelerate innovation and improve patient outcomes.
Novartis is expanding with a new California facility and an Indianapolis upgrade to boost radiopharmaceutical production and meet growing demand.
iCardio.ai partners with SARC MedIQ to integrate AI into ultrasound imaging, improving diagnosis speed and accuracy.
Vasa Therapeutics' lead drug, VS-041, enters clinical trials, aiming to treat heart failure with preserved ejection fraction.
Pharma Now announces media partnership with Pharma Packaging and Labeling Forum 2024, covering innovations and trends.
Nxera Pharma Co. recognizes Centessa's promising Phase 1 results for ORX750, a potential narcolepsy treatment, demonstrating strong safety and efficacy.
Ascendis Pharma's YORVIPATH secures FDA Orphan Drug exclusivity for treating adult hypoparathyroidism, granting seven years of U.S. market exclusivity.
Chicago Rockford International Airport (RFD) launches a GDP-certified pharma trade lane from India, boosting efficiency and cutting CO2 emissions.
BIOCAPTIVA’s new US patent for liquid biopsy tech boosts cfDNA extraction, enhancing disease detection and personalized medicine.
Sanofi and Regeneron's Dupixent shows strong potential in treating bullous pemphigoid, chronic urticaria, and COPD, possibly changing treatment standards.
GSK’s HSV vaccine candidate fails phase II, halting progress. The company continues safety and follow-up analysis.
Novo Nordisk's weight loss pill shows promising early results, with up to 13% body weight loss in 12 weeks.
BGS Beta-Gamma-Service opens its first U.S. sterilization facility, addressing growing demand for E-Beam technology.
Turbine’s AI platform helps Ono identify cancer targets, accelerating drug discovery with in vitro validation.
Tesla BioHealing and Cell Biotechnology partner to revolutionize stem cell therapies with advanced biophoton technology.
Sino Biological and BioGeometry team up to revolutionize protein design and optimization with advanced AI technology.
Pharma M&As drive innovation, expand reach, enhance healthcare solutions, and strengthen market positions worldwide.
DeCODe consortium launches to support paediatric and orphan device development for children with rare diseases in Europe.
C2 PHARMA introduces Naphazoline HCL, a versatile API for red eyes and nasal relief. Awaiting CEP approval, with US-DMF and Brazil filings set for 2024.
Zeto teams up with Firefly Neuroscience to integrate AI with EEG headsets, improving brain health diagnostics.
Nona Biosciences and Umoja Biopharma partner to develop novel CAR-T cell therapies using proprietary antibody platforms.
NS Pharma's NS-050/NCNP-03 for Duchenne receives FDA Rare Pediatric Disease status, bringing new hope with its exon-skipping approach.
Arrowhead Pharmaceuticals’ RNAi treatment, plozasiran, gains FDA breakthrough status, speeding up development for rare genetic condition FCS.
Moderna’s mRNA-4359 vaccine shows promise in early trials for advanced cancer, boosting immune response with minimal side effects.
AdjuTec Pharma begins Phase I trials for APC148, targeting antibiotic resistance, with safety studies starting on Sept 18 in Uppsala, Sweden.
FDA authorises first over-the-counter hearing aid software for AirPods Pro, making hearing support more accessible.
Biocomposites introduces its NanoBone product range in the UK, providing surgeons with cutting-edge bone graft solutions.
Merck's KEYTRUDA improves 5-year overall survival by 34% in high-risk early-stage TNBC, showing a significant benefit.
MOB-015 Phase 3 trial shows fewer clinical cures than expected; Cypher holds Canadian commercialization rights.
Prelude's PRT3789 shows early efficacy in Phase 1 trial, reducing tumors in SMARCA4-mutated cancers with mild to severe effects.
Ascendis Pharma's TransCon IL-2 β/γ shows 29% clinical response in pretreated, platinum-resistant ovarian cancer patients.
Richter Biologics unveils its new P2 production facility, expanding capacity for pDNA, vaccines, nanobodies, and recombinant proteins, with a €95M investment.
Aarti Drugs and IPCA Laboratories face ransomware attacks; sensitive financial and employee data exposed online.
Eli Lilly's eczema drug, Ebglyss, gets FDA approval for adults and children over 12, offering monthly doses for atopic dermatitis. Available soon in the US.
FDA approves Strides Pharma's generic fluoxetine, boosting dosage options and expanding the market for depression treatment.
Piramal Pharma's GHG reduction goals get SBTi approval, aiming for a 42% cut in scope 1 and 2 emissions by FY2030.
J&J MedTech’s Shockwave Medical introduces the E⁸ IVL catheter, tackling complex peripheral artery disease
FDA approves Roche’s Ocrevus Zunovo, the first subcutaneous injection for relapsing and primary progressive MS.
Myeloid Therapeutics debuts Aurora Biosynthetics in Sydney to drive GMP production of RNA therapeutics in Asia-Pacific.
APIIC secures $16.4M to produce crucial APIs for asthma, diabetes, and anxiety, boosting U.S. pharmaceutical manufacturing and supply chain resilience.
Argon Medical launches a Thrombectomy system CLEANER Vac™, that aids blood clot removal, eases technically compound procedures for physicians.
Tonix Pharma's TNX-801 mpox vaccine meets WHO criteria, promising single-dose effectiveness and ambient temperature stability.
Utah will resume its lawsuit against Richard Sackler and Purdue Pharma, seeking justice for deceptive OxyContin marketing after a 60-day pause.
Smith’s Medical Recall Airway tubes, linked to several injuries & one death, received warning letters and frequent quality problems.
Epitomee Medical gains U.S. FDA clearance for its drug-free Epitomee® Capsule, helping adults with BMI 25-40 manage weight through diet and exercise.
Sanofi ships BEYFORTUS, the first RSV prevention antibody for infants, to healthcare providers ahead of RSV season.
Zentalis announces FDA has lifted the hold on azenosertib studies. The company will reveal new data and updates at a corporate event later this year.
nfigratinib by BridgeBio earns FDA Breakthrough Therapy Designation, advancing treatment options for achondroplasia.
Boston Scientific’s INGEVITY™+ Pacing Leads now FDA-approved for expanded use in conduction system pacing and left bundle branch area monitoring.
Liquidia secures a win as United Therapeutics is found liable for $137M in losses over delayed Treprostinil launch.
Capricor Therapeutics and Nippon Shinyaku bind a term sheet for augmentation of sales and development of Deramiocel.
LEO Pharma launches a single-dose auto-injector for Adbry (Tralokinumab) in the U.S., enhancing treatment for moderate-to-severe atopic dermatitis.
Novo Nordisk GBS launches Eco Med Safe to revolutionize medication disposal and safeguard the environment.
GSK partners with Brooke Shields for THRIVE@50+, empowering those over 50 to prioritize health, raise shingles awareness, and embrace aging confidently.
The MHRA launches a strategy to transform safety communications, providing clear, targeted safety updates for the UK.
MIRA Pharmaceuticals aims to demonstrate clinical efficacy of its oral ketamine analog in 2025 with Phase I/II trials.
AstraZeneca’s Fasenra approved by FDA for EGPA, a rare vasculitis. It helps patients reduce dependence on steroids.
Aligos Therapeutics to announce Phase 2a results for MASH treatment ALG-055009 and host webcast on September 19, 2024.
Rocket Pharmaceuticals completes enrollment for pivotal Phase 2 trial of RP-A501, a gene therapy for Danon disease.
Merck’s KEYTRUDA gains FDA approval for first-line use in advanced mesothelioma, improving survival when combined with chemotherapy.
Plus Therapeutics will present its innovative radiotherapeutics for GBM and CNS cancers at the 2024 CNS Annual Meeting in Houston, TX.
BioMarin's ISDS 2024 data shows VOXZOGO® boosts height and quality of life in children with achondroplasia and other genetic disorders.
Pharma Now partners with Evolution Summit 2024 to spotlight clinical trial innovations and insights.
Zydus Lifesciences recently announced its acquisition of Sterling Biotech’s API for cash compensation of Rs 84 crore.
Charles River and CEBINA announce collaboration for novel neuroscience research, fulfilling medical needs globally.
Patients with EGFR-mutated NSCLC who had previously received EGFR-TKI treatment were treated with Patritumab Deruxtecan and achieved vital endpoints.
Genentech's Xofluza reduces influenza transmission in a Phase III trial, showing promise for pandemic preparedness.
Newron Pharmaceuticals reports strong clinical progress with evenamide for schizophrenia, plus H1 2024 financial updates.
Hyphens Pharma launches Ceradan® Advanced Hand Balm with patented pH control, offering targeted relief and protection for hand eczema.
Pharma Now to cover key trends and innovations at the Global Pharma Supply Chain & Logistics Forum, Munich 2024.
GSK's Blenrep, in combination therapies, is under review by Japan's MHLW for relapsed/refractory multiple myeloma.
Astellas Pharma’s DIGITIVA™ earns FDA listing as a Class I SaMD, debuting in the U.S. digital health market with at-home heart failure monitoring.
Takeda to disclose new data on TAK-861 for Narcolepsy at Sleep Europe 2024, September 24-27 in Seville, Spain”
Tonix Pharmaceuticals gets U.S. Patent No. 12,090,139 for Tosymra®'s intranasal migraine treatment, enhancing its market position and IP protection.
Hovione and iBET launch ViSync® in Portugal to enhance drug delivery and stabilization in cell and gene therapy, combining expertise in pharma and biotech.
Abbott India signs an agreement with Takeda to commercialize Vonoprazan, offering better GERD treatment options.
Novartis reports significant Kesimpta outcomes in reducing MS progression, showing promise for first-line treatment.
FUJIFILM Irvine Scientific's Oceo Rover, automated hydration system changing media prep and bioprocessing efficiency.
Achilles Therapeutics halts its TIL-based trials, shifts focus to new cancer treatments, and explores strategic options with BofA Securities.
Glenmark Pharmaceuticals' Aurangabad plant successfully passes U.S. FDA inspection with zero observations.
FDA approves Sarclisa with VRd for newly diagnosed multiple myeloma patients, improving progression-free survival by 40%.
Lupin receives FDA approval for generic Bumetanide Injection, used to treat edema linked to heart, liver, and kidney diseases.
AbbVie’s ELAHERE® receives EMA recommendation for treating platinum-resistant ovarian cancer after prior therapies.
EMA recommends Pfizer-BioNTech's Omicron KP.2-adapted COVID-19 vaccine for individuals 6 months and older in the EU.
Teva's SOLARIS trial shows TEV-749, a monthly injectable, reduces schizophrenia symptoms with no PDSS and a strong safety profile.
Dupixent receives a positive opinion from European regulators for treating eosinophilic esophagitis in young children.
Zeposia shows sustained brain volume loss reduction and maintains safety in long-term study for multiple sclerosis.
Teva presents new data on transitioning schizophrenia patients from Perseris® to UZEDY® at ECNP Congress.
Imexpharm focuses on talent recruitment, R&D, and global expansion to secure a leading position in Vietnam’s pharmaceutical market.
AdjuTec Pharma launches phase 1 trial for APC148, aiming to combat antibiotic resistance and improve public health.
Longboard’s lead candidate, bexicaserin, gains FDA Rare Pediatric Disease and Orphan Drug designations for Dravet syndrome.
HudsonAlpha team employs long-read sequencing to re-analyze genomes, improving diagnostic rates for rare genetic disorders.
Huawei establishes an AI driven system that aids accuracy, diagnosis and intelligent quality control.
Pharma Giant Novo Nordisk to reveal the massive demand for its weight loss drugs, Ozempic and Wegovy.
Capricor Therapeutics will discuss the latest FDA regulatory updates for its Duchenne program during a webcast.
Tonix Pharmaceuticals reveals Phase 3 success for TNX-102 SL in fibromyalgia, aims for 2025 FDA approval.
AstraZeneca’s Fasenra recommended in EU for relapsing eosinophilic granulomatosis with polyangiitis, based on Phase III data.
Innate Pharma receives FDA clearance to begin Phase 1 trial of IPH4502, a Nectin-4-targeting ADC for solid tumors.
LEO Pharma gains EC approval for Anzupgo® cream, offering a new treatment for moderate to severe chronic hand eczema.
Datopotamab deruxtecan shows progression-free survival benefits but fails to meet overall survival in key breast cancer trial.
BioAtla and Context Therapeutics sign a deal for BA3362, a TCE antibody for solid tumours, with Context leading development and commercialization efforts.
Chugai wins approval for Evrysdi to treat pre-symptomatic SMA, enabling early intervention for infants through genetic screening.
Japan approves Veltassa® for hyperkalemia treatment in adults, offering effective potassium control for CKD and HF patients.
India's largest-ever analytica Anacon India, India Lab Expo, and Pharma Pro&Pack Expo to bring global insights to Hyderabad.
atalyst Pharmaceuticals' partner, DyDo Pharma, gets approval to commercialize FIRDAPSE® in Japan for LEMS.
Allergan Aesthetics launches 2024 BOTOX® Cosmetic grants, empowering women entrepreneurs through mentorship, grants, and crowdfunding support.
Acurx Pharmaceuticals unveils exciting ibezapolstat research, spotlighting its potential against C. difficile infections.
Takeda gains approval in Japan to market FRUZAQLA for advanced colorectal cancer, providing new hope for patients.
Dr. R.N. Gupta appointed as National President of IPA for 2024-2026. With 50 years in pharma, he has made significant contributions to the industry.
Preclinical data for the treatment of KRAS mutated cancers to be presented at the 6th Annual RAS-Targeted Drug Development Summit.
Alvotech begins a trial for AVT16, a biosimilar to Entyvio®, to test its effectiveness and safety for Ulcerative Colitis.
Cyclacel Pharmaceuticals completes enrollment of 12 patients in Cohort 8 of its Phase 2 study of fadraciclib for advanced solid tumors and lymphoma.
Merck's KEYTRUDA (pembrolizumab) has gained expanded approval in Japan for non-small cell lung cancer and urothelial carcinoma, offering new treatment options.
Sanner's acquisition of Gilero enhances its global CDMO services and capabilities in drug delivery and medtech.
AbbVie’s analysis shows upadacitinib improves moderate-to-severe atopic dermatitis in the head and neck over 16 weeks.
Pfizer voluntarily recalls all OXBRYTA® lots from global markets, addressing concerns for sickle cell disease treatment.
Analytica Anacon, India Lab Expo & Pharma Pro & Pack Expo 2024, Hyderabad, attracts over 25,000 participants exploring innovations in pharma and packaging.
Acurx’s ibezapolstat enhances microbiome health, reduces CDI recurrence, and shows activity against anthrax in trials.
Enanta Pharmaceuticals reports promising Phase 2a results for EDP-323, showing significant RSV viral load reduction and strong safety.
NI Pharmaceuticals unveils FDA-approved Ketoconazole Shampoo, 2%, a generic to Nizoral®, in a $69.2M market.
Merck unveils new long-term data on tulisokibart for UC and CD at UEG Week 2024, showcasing sustained efficacy and safety from Phase 2 studies.
Vertex reveals Phase 3 data on vanza triple CF therapy at NACFC, showing long-term benefits of TRIKAFTA in children.
Acadia’s Board grants equity awards to new CEO Catherine Owen Adams as part of the 2024 Inducement Plan.
Join the 23rd ISoP Annual Meeting in Montreal from October 1–5, 2024, to explore global perspectives on pharmacovigilance and advanced therapeutics.
Tonix Pharmaceuticals secures a U.S. patent for Zembrace® SymTouch® autoinjector, promoting non-oral treatments for faster migraine relief.
New preclinical data on Ketamir-2 will be presented at the 18th Annual Pain Therapeutics Summit in Boston.
Lupin's unit received a Form 483 with three observations, Alembic got an EIR, while Piramal received no observations and an EIR from USFDA.
Jeil Pharmaceutical launches Jaqbo, a P-CAB for peptic ulcers, marking its first in-house drug in 65 years and entering Korea's $1 billion market.
Bayer submits sNDA for NUBEQA to the FDA, aiming to expand its use in metastatic prostate cancer with ADT.
Eris Lifesciences secures CDSCO approval to manufacture an FDC for type 2 diabetes, with Phase IV trials required post-launch.
AbbVie applies for FDA accelerated approval of telisotuzumab vedotin for previously treated non-small cell lung cancer.
Dupixent, by Sanofi and Regeneron, is now FDA-approved for COPD, marking its sixth indication for this blockbuster drug.
Innate Pharma and the Icahn School of Medicine will co-host a hybrid symposium, "Next Generation Immunotherapy Discoveries," on October 3, 2024.
Daewoong Pet enters the CRO sector to develop specialized veterinary medicines, addressing the growing demand for pet pharmaceuticals and clinical trials.
The FDA granted Priority Review for Enhertu, targeting HER2-low breast cancer patients based on positive DESTINY-Breast06 trial results.
Ascendis Pharma submits sBLA to the FDA for TransCon hGH to treat adults with growth hormone deficiency.
Seres Therapeutics sells VOWST™ rights to Nestlé, refocusing on biotherapeutics for high-risk infections in vulnerable patients.
Scorpius Holdings partners with a clinical-stage immuno-oncology firm, offering bioanalytical services and expanding GMP manufacturing capabilities.
Aligos Therapeutics names David Perry as VP of Business Development to drive partnerships and advance its drug pipeline.
BioAtla to showcase Evalstotug (BA3071), a CAB anti-CTLA-4 antibody, at the 2024 Society for Melanoma Research Congress.
Plus Therapeutics presents encouraging safety and efficacy data from Phase 1/2 trial for recurrent glioblastoma therapy.
Surmodics gains FDA approval for the Pounce XL Thrombectomy System, broadening its platform for treating peripheral arteries.
Addition of CN201’s bispecific antibody, enhances Merck's pipeline, targeting B-cell malignancies and autoimmune diseases.
Amneal and Metsera have partnered to develop and supply new global weight loss medicines for obesity and metabolic diseases.
SAWC Fall offers a platform to educate clinicians on the AC5 Advanced Wound System, showcase case studies, and hold strategic meetings with wound care firms.
Recipharm and Exela Pharma Sciences have partnered to enhance sterile manufacturing in the US, focusing on injectable pharmaceutical production.
Pliant Therapeutics appoints Dr. Gary Palmer as Senior VP of Medical Affairs, bringing 25+ years of medical leadership
Brazil honored by WHO for eliminating lymphatic filariasis, a major public health issue. Through strong measures, it joins 19 countries free from the disease.
Scorpius selected for MCDC membership, advancing medical countermeasures to protect against CBRN threats and safeguard national security.
Processa Pharmaceuticals dosed its first patient in a Phase 2 trial for NGC-Cap, aiming to improve breast cancer chemotherapy.
Recursion announced FDA clearance for its IND application to begin a Phase 1/2 trial of REC-1245, targeting biomarker-enriched solid tumors and lymphoma.
Charles River and Lundbeck have partnered to use AI-powered Logica® to enhance the discovery of novel drugs targeting central nervous system disorders.
In 2024, Globus set forth several new system extensions, including the TENSOR™ Suture Button System, & received FDA clearance for orthopaedic products.
Alembic Pharmaceuticals has secured US FDA final approval for its Lamotrigine Extended-Release Tablets in 200 mg, 250 mg, and 300 mg dosages.
Gilead signs licensing deals with six manufacturers to produce generic lenacapavir for HIV prevention in 120 nations.
Afton Scientific Expands Virginia Facility with $200M Investment, creating 200+ Jobs and Boosting Local Biopharma Innovation and Economic Growth.
Lonza acquires Roche's Vacaville biologics site for $1.2 billion, enhancing U.S. manufacturing capacity for next-gen therapies.
Norgine appoints Janneke van der Kamp as CEO, effective January 1, 2025, to drive growth and innovation.
Lilly invests $4.5B in a new Medicine Foundry to boost drug innovation, optimize production, and create 400 jobs in Indiana's LEAP District.
Nicomac Mangini unveils ANIMA AI at CPHI Milan 2024, optimizing pharmaceutical production with real-time monitoring and digital twin simulation.
Kane Biotech gets $75k in NRC IRAP support for DispersinB® Wound Gel R&D, plus $200k for revyve™ tech advancement.
Legend Biotech announces a new R&D facility in Philadelphia, set to boost its next-gen cell therapies by Q3 2025.
David Meline adds deep financial and industry expertise to Lonza’s Board, while Olivier Verscheure has chosen not to stand for re-election at the 2025 AGM.
analytica Anacon India 2024 highlighted 7,000+ products, attracting 25,000 visitors and fostering global innovation.
Charles River Laboratories will showcase 18 scientific posters at Neuroscience 2024, held from October 5-9 in Chicago, collaborating with clients and experts.
Amira Modi joins Sygnature Discovery as COO and Board Member, bringing extensive life sciences experience to drive growth and innovation.
Discover Cellevate's innovative nanofiber microcarriers at CPHI Milan, enhancing viral vector production with 60x more cell growth area.
Sterling Pharma Solutions partners with Soligenix to manufacture GMP-quality synthetic hypericin for clinical development of HyBryte™ targeting rare diseases
WHO established the Global Strategic Plan to tackle diseases like dengue and Aedes -borne arboviruses.
Theriva Biologics presents positive DSMC review for Phase 1b/2a trial of SYN-004 in allogeneic hematopoietic cell transplant recipients, advancing to Cohort 3.
WHO lists first mpox diagnostic under Emergency Use, expanding testing capacity in countries facing outbreaks.
WHO clears single-dose HPV vaccine Cecolin®, expanding vaccine access and helping prevent cervical cancer in girls worldwide
Recordati strengthens its rare diseases portfolio by acquiring Enjaymo®, the only treatment for cold agglutinin disease.
Halozyme collaborates with argenx, adding four new targets for ENHANZE® technology to enhance subcutaneous drug delivery.
Telix’s Illuccix® gains Health Canada approval for selecting mCRPC patients for PSMA-targeted radionuclide therapy.
With 12 fatalities from Marburg, Rwanda initiates a vaccine trial to combat the outbreak and safeguard citizens' health.
AstraZeneca has licensed CSPC's Lp(a) disruptor, YS2302018, aiming to enhance treatments for dyslipidaemia.
DKSH Korea acquires Kyowa Kirin Korea’s specialty pharma unit, enhancing its hematology and nephrology portfolio with key products like Grasin.
Aspire Pharma expands its dermatology and allergy lines by acquiring Canute Pharma, enhancing its portfolio with innovative patient care products.
OnKure merges with Reneo to form OnKure Therapeutics, trading as ‘OKUR,’ advancing cancer treatment innovation.
Discover the 800% surge in mRNA licensing agreements since 2019, highlighting growing confidence in innovative therapies and vaccines.
Afton Scientific expansion in Albemarle County with a $200M investment, adding 200+ jobs and advancing biotech capabilities.
Airsupra significantly reduces the risk of severe asthma attacks, showing positive results in the BATURA Phase IIIb trial.
MTPA shares insights on RADICAVA ORS® treatment for ALS patients at the 2024 NASP Annual Meeting & Expo.
At CPHI Milan 2024, Thermo Fisher will highlight innovations in drug development and sustainability initiatives in healthcare.
Nobel Prize in Medicine honors two Americans for discovering microRNAs, essential in controlling gene expression.
Vincerx Pharma's Phase 1 trial of VIP943 demonstrates positive results in AML, HR-MDS, and B-ALL with complete responses, no dose-limiting toxicities.
Orchard Therapeutics teams up with Er-Kim to distribute Libmeldy, a gene therapy for early-onset MLD in Turkey & Eurasia.
Celly Nutrition partners with FUSION to expand the reach of unbuzzd™, an alcohol metabolism supplement.
Inozyme Pharma adds Erik Harris to its board, leveraging his expertise to advance rare disease therapy INZ-701.
Nipro Launches D2F™ Vials with Stevanato Group's EZ-fill® Technology for Pharma Industry's RTU Needs.
Boehringer Ingelheim's survodutide receives FDA Breakthrough Therapy status for metabolic dysfunction-associated steatohepatitis, accelerating clinical trials.
Synexa Life Sciences boosts its bioanalysis capabilities with the acquisition of Alderley Analytical, enhancing biomarker services for drug development.
Virios Therapeutics and Wex Pharmaceuticals team up to launch Dogwood Therapeutics, advancing treatments for neuropathic pain, fibromyalgia, and Long-COVID.
Discover innovations in battery production, energy storage, and electric mobility at AMPTECH India Expo 2024, Gujarat.
KEYNOTE-689 trial shows KEYTRUDA’s success in improving event-free survival and pathological response in LA-HNSCC.
Positive results from the Phase 3 ASPEN study highlight brensocatib’s potential in treating bronchiectasis effectively.
India has been commended by WHO for eliminating trachoma as a public health problem through effective sanitation efforts.
RTI Surgical has agreed to acquire Collagen Solutions, aiming to boost its capabilities in collagen-based medical devices.
Intas Pharmaceuticals welcomes Sridharan S as Executive VP of API Operations, bringing 28 years of expertise to the role.
Colorcon partners with LOTTE to expand pharma solutions, offering exclusive access to advanced drug formulation and delivery polymers.
Eppendorf launches the CellXpert CS220, a CO2 incubator shaker with 180˚C sterilisation for superior contamination protection and increased flask capacity.
Kindeva Drug Delivery's Bridgeton facility marks a milestone with its first registration batch, boosting injectable fill-finish services and capacity.
BD and ten23 Health Partner to Innovate Aseptic Manufacturing with RFID Technology for Enhanced Prefillable Syringe Traceability.
Tonix Pharmaceuticals partners with X-Chem to harness AI in developing broad-spectrum antiviral drugs, aiming to boost virus-fighting capabilities worldwide.
Novo Nordisk's new global initiative aims to prevent childhood obesity through tailored interventions in six cities.
Cipher Pharmaceuticals names Dr. Hamed Ghanei as CBO, bringing 15+ years of experience in pharmaceuticals and M&A deals.
Catalyst Pharmaceuticals contributes $100,000 to the American Red Cross to aid families destroyed by Hurricane Helene.
Attend the 6th Annual Pharma Manufacturing and Automation Convention in Hyderabad on October 17-18 for industry insights.
Capricor initiates FDA rolling submission for deramiocel to treat DMD cardiomyopathy and seeks full approval by 2024.
Viatris announces successful Phase 3 trial in Japan, showing EFFEXOR®'s efficacy and safety for treating GAD.
Entrada Therapeutics shares positive clinical and preclinical data on DMD treatments at the World Muscle Congress 2024.
Merck will showcase critical findings from its vaccine and infectious disease portfolio at IDWeek 2024, including RSV and HIV research.
Pharma Now celebrates CPHI Milan's 14 awardees for innovation in pharma, from AI-enabled APIs to sustainability, showcasing industry excellence.
Insitro teams up with Eli Lilly to develop AI-driven therapies targeting metabolic diseases, including MASLD.
Mestag collaborates with MSD to discover novel drug targets for inflammatory diseases using its RAFT platform.
Pharma Now recaps CPHI Milan's first two days, highlighting industry innovations, networking, and culinary delights.
Panthera Biopartners becomes the first UK clinical trial site to join Parexel’s global Site Alliance Vaccine Network.
Foghorn's selective SMARCA2 oncology program is part of a U.S. co-development and commercialisation collaboration with Lilly.
Tempest Therapeutics collaborates with Roche to evaluate amezalpat in a Phase 3 trial for unresectable liver cancer.
Cytovale has secured $100 million in funding to accelerate the commercial expansion of IntelliSep for sepsis detection.
Genentech's Itovebi gains FDA approval for PIK3CA-mutated breast cancer, significantly improving treatment outcomes
Nicomac Mangini showcases AI innovations and seismic-certified cleanrooms for optimal pharma production at CPHI 2024.
Pharma Now partners with PharmaPack 2024, covering innovations in pharmaceutical packaging on October 17-18 in California.
Burning Rock and Dizal receive NMPA approval for their co-developed EGFR exon20ins CDx, a first for lung cancer in China.
Arbele collaborates with BioAI and Chime Biologics to accelerate AI-powered cancer therapies and companion diagnostics.
Lipocine's qEEG study confirms CNS engagement of oral brexanolone, supporting its use in psychiatric and neurological conditions.
At IDWeek 2024, GSK and ViiV Healthcare will showcase data on vaccines and treatments for infectious diseases.
Pharma Now celebrates CPHI 2024's success in Milan, featuring groundbreaking pharma innovations, new award categories, and key startups shaping the future.
PW Skills launches School of Healthcare to address India's shortage of trained medical professionals, offering practical and hands-on vocational training.
The second phase of Gaza's polio vaccination campaign starts, aiming to protect 591,700 children with a second dose.
Explore innovations, trends, and regulatory updates in the pharma and chemical industries at Baddi Expo 2024 from Oct 21-23.
The FDA reconsiders the decision, allowing compounders to keep selling cheaper alternatives to Lilly's weight loss and diabetes drugs.
Evonik reorganizes the Coating & Adhesive Resins and Health Care divisions, focusing on core growth areas and divesting non-core businesses for growth.
Enhertu gets conditional approval in China for treating HER2-mutant NSCLC, pending confirmation of clinical benefits.
New data shows Evrysdi helps children with SMA achieve key mobility milestones, underscoring the benefits of early treatment for improved outcomes.
Jonathan Dickinson joins Innate Pharma as CEO and Chairman, bringing extensive biotech expertise to advance innovative immuno-oncology therapies.
LTR Pharma's SPONTAN® shows 470% faster absorption for ED treatment, promising enhanced spontaneity and safety in pivotal study results.
FDA guides Clarity Pharmaceuticals' Phase III trial for 64Cu-SAR-bisPSMA, enhancing prostate cancer diagnostics.
RedHill Biopharma's opaganib selected by BARDA for Ebola treatment, advancing through FDA's Animal Rule with promising results in survival studies.
Samsung Biologics introduces S-HiConTM, a platform enhancing stability and efficacy in high-ose biopharmaceuticals
Ardena secures Catalent's New Jersey facility to boost oral drug manufacturing and broaden its US services.
Exelixis and Merck collaborate to study zanzalintinib with KEYTRUDA and WELIREG in cancer clinical trials.
Lundbeck announces the acquisition of Longboard Pharmaceuticals, which is advancing neurological therapies.
Noul partners with PT Kirana Jaya Lestari to distribute its AI blood testing solution, miLab BCM, in Indonesia, enhancing healthcare efficiency.
Eli Lilly reports promising one-year histologic outcomes for mirikizumab in Crohn's disease, showing significant improvements over ustekinumab.
Cycle Pharmaceuticals proposes to acquire Vanda Pharmaceuticals, offering an 80% premium amid ongoing refusal to engage.
Suven Pharma names Declan Ryan as Chief Commercial Officer. He has 25 years of experience with companies like WuXi, Johnson & Johnson, and Novartis.
Bayer seeks EMA approval for elinzanetant to treat moderate to severe menopause-related hot flashes.
Indaptus progresses Decoy20 Phase 1 trial, with unrestricted patient enrollment at the lower dose approved.
Jazz Pharma Reports Significant Overall Survival and Progression-free Survival for Zezelca and Atezolizumab in First-Line ES-SCLC Maintenance Therapy
Omega Therapeutics announces that it will share preclinical data on epigenomic mRNA medicines at three key conferences.
Pfizer appoints ex-Vanguard CEO Tim Buckley to its Board, joining the Governance, Sustainability, and Audit Committees.
LGM Pharma expands its testing services with endotoxin and rapid sterility testing, offering faster, cost-effective solutions for drug developers.
Pharma India Expo 2024 showcases the latest in pharma machinery, drug development, and networking with industry leaders.
Commit Biologics appoints Dr. Mikkel Pedersen as CSO to lead R&D and develop its BiCE™ technology for cancer and autoimmune therapies.
Berry Global's ClariPPil™ bottles provide sustainable, recyclable packaging with enhanced product protection and reduced CO₂ emissions.
FDA accepts UroGen's NDA for UGN-102, a potential breakthrough for non-muscle invasive bladder cancer, with a PDUFA date of June 2025.
Lantern Pharma's LP-184 secures FDA Fast Track Status, advancing treatment options for Glioblastoma and offering hope for patients.
Circle Pharma's CID-078 enters Phase 1 trials, offering innovative oral treatment options for advanced solid tumors.
LEO Pharma launches Anzupgo® cream in Germany, offering a new treatment for moderate to severe Chronic Hand Eczema.
Astria's navenibart granted OMPD in Europe for HAE, showing 90-96% attack reduction in early trials.
Theriva's VCN-01 receives EU orphan status for retinoblastoma, marking progress in pediatric cancer therapy.
Perspective Therapeutics ships its first patient doses from a new NJ facility, marking a milestone in producing radiopharmaceuticals for cancer treatment.
Keros Therapeutics announces Dr. Yung H. Chyung as Chief Medical Officer, effective November 1, 2024.
Apellis Pharmaceuticals reveals an oral presentation on pegcetacoplan at ASN Kidney Week and two additional posters.
Medical Affairs Summit 2024 in Boston will spotlight strategic innovations, best practices, and regulatory insights in healthcare.
Univercells debuts scale-X™ nexo bioreactor for efficient, scalable cell culture, reducing costs by up to 60%.
Olivier Falut joins EUROAPI as CFO on October 17, 2024, bringing 30 years of financial expertise to the role.
Uhlmann Pac-Systeme inaugurates its new Pune office, showcasing cultural performances and a commitment to innovation.
Tonix Pharmaceuticals submits NDA for TNX-102 SL, which shows efficacy in fibromyalgia in Phase 3 trials and is now under FDA review.
Health Canada approves Acadia’s DAYBUE™ as Canada’s first treatment for Rett syndrome, offering new hope for patients and families.
Matica Bio partners with Mongoose Bio to advance lentivirus production for TCR-T cell therapy, boosting innovation in Texas's biocluster.
Cellular Origins & Fresenius Kabi partner to scale CGT automation, integrating Cue® with Constellation™ for efficient cell therapy production.
AbbVie's VYALEV receives FDA approval as the first 24-hour levodopa-based subcutaneous infusion for advanced Parkinson's.
Kane Biotech signs a 5-year deal to distribute XSONX's Wound Hygiene System across Canada, Australia, and GCC.
Swissmedic grants marketing approval of FILSPARI® for IgAN treatment based on significant phase-III PROTECT trial results from CSL Vifor and Travere.
Charles River introduces the Retrogenix® Non-Human Protein Library to improve off-target assessments.
Orano inaugurates its first 4.0 plant in Cherbourg, producing the TN Eagle cask for safer, efficient nuclear fuel storage.
Virica and eXmoor collaborate, funded by Canada-UK program, to enhance AAV production and reduce gene therapy costs.
Amylyx's AMX0035 shows promising Phase 2 results, improving pancreatic function in Wolfram syndrome patients.
Poseida selects a new CAR-T candidate with Roche, targeting hematologic cancers to enhance treatment options.
Sanofi and Orano Med partner to advance next-gen targeted alpha therapies for rare cancers, combining biopharma and nuclear expertise for precision treatment.
Merck's Clesrovimab cuts RSV risk in infants by 60% in trials, showing promise in preventing severe cases during their first RSV season.
Novo Nordisk's Alhemo® may soon offer the first once-daily subcutaneous treatment for haemophilia A or B with inhibitors.
World Drug Safety Congress 2024 in Boston highlights AI integration, regulatory updates, and innovations in drug safety.
Eylea 8 mg offers extended dosing intervals up to 20 weeks, reducing treatment burden and enhancing patient outcomes.
Korea BNC partners with Dongkook Pharmaceutical to distribute Bienox, a botulinum toxin that reduces frown lines.
FibroBiologics collaborates with Charles River to manufacture fibroblast-based CYWC628 for diabetic foot ulcer trials.
BOTOX® Cosmetic has gained FDA approval for treating platysma bands, becoming the first product in four aesthetic areas.
Dharmesh Kharwar appointed Independent Director at ENTOD Pharmaceuticals, bringing vast industry expertise.
Gland Pharma names Shyamakant Giri as CEO, effective January 2025, bringing over 25 years of global pharma experience.
Omnipaque is approved in Korea for contrast-enhanced mammography, boosting breast cancer detection and patient outcomes.
FDA approves Astellas' gastric cancer treatment, Vyloy, enhancing survival rates alongside chemotherapy.
Egypt is certified malaria-free by WHO, becoming the third country in its region to achieve this milestone.
Eleven monkeys died from melioidosis infection at Hong Kong Zoo, likely due to contaminated soil brought into enclosures.
VYLOY is the first CLDN18.2-targeted therapy that has gained FDA approval for treating advanced gastric and GEJ cancer.
The investigational once-weekly islatravir and lenacapavir combination shows 94.2% viral suppression in HIV patients after 48 weeks.
Angelini Pharma partners with Cureverse to advance CV-01, a breakthrough brain health treatment, securing global development rights.
CHMP recommends WAINZUA (eplontersen) for EU approval to treat hereditary polyneuropathy, offering a potential self-administered option.
Paris backs a €15 billion sale of Sanofi's paracetamol unit to US fund CD&R, ensuring job security and no impact on essential medicines.
MIRA's KETAMIR-2 shows superior efficacy and safety over current therapies in preclinical pain management studies.
Novo Nordisk’s concizumab receives FDA fast-track status, accelerating development for hemophilia A and B treatment.
Amneal's NDA for Pyridostigmine Bromide Extended-Release tablets gets FDA approval for nerve agent poisoning treatment in military use.
Inventiva to present Phase 2 LEGEND study on lanifibranor & empagliflozin in MASH & T2D at AASLD Liver Meeting 2024, Nov 18, 8 AM-5 PM PST, San Diego.
Acurx announces evaluation of the new Phase 2B trial of Ibezapolstat, presented at the IDWeek meeting.
Recursion partners with Google Cloud to leverage AI and tech for faster, cost-effective drug discovery.
Nucleus expands R&D and manufacturing capacity to address radiopharmaceutical supply chain constraints with two new sites.
Pharma Tech Industries names Darrin Schellin as CEO to drive innovation and growth in contract manufacturing.
ABIONYX Pharma advances CER-001 for LCAT deficiency with EMA support, completing a key step in its EU conditional approval process.
B.Grimm Pharma partners with Inter Mohosot to expand access to essential medicines in Cambodia, improving healthcare for key conditions.
WHO and SNOMED International discuss linking ICD-11 and SNOMED CT to improve global health data interoperability.
Recursion's Phase 2 trial begins with the first patient dosed, testing REC-994 for cerebral cavernous malformation (CCM).
Scorpius Holdings forms a strategic partnership with U.S. biotech, transferring RCB for future biomanufacturing.
Alvotech and Teva's SELARSDI receives FDA approval for a new formulation, launching in the U.S. by early 2025.
Aligos receives FDA approval for Phase 1 study of ALG-000184, targeting Chronic Hepatitis B with potential superior efficacy.
Peli BioThermal introduces the Credo Vault, ensuring safe transport of temperature-sensitive pharmaceuticals globally.
Lonza opens a new facility in Geleen, Netherlands, to boost production of plasmid DNA for gene therapies.
Indaptus and BeiGene will start a 2025 trial combining Decoy20 with PD-1 inhibitor tislelizumab for innovative cancer treatment.
Samsung Biologics inks a $1.24B deal with an Asia pharma giant, expanding global manufacturing through 2037.
Parexel appoints Keri Mattox as Chief Business Officer to drive growth and innovation in a pivotal leadership shift.
Bormioli Pharma and Chiesi launch Carbon Capture PET bottles, reducing CO2 emissions by 21.9% in pharma packaging.
NorthStar Medical Opens A New Facility In Beloit, boosting radiopharmaceutical production for cancer therapies & medical imaging.
Avantor strengthens its partnership with NIBRT, enhancing biopharma manufacturing and training critical industry talent.
Cold Chain Technologies strengthens its product portfolio and global presence by acquiring Tower Cold Chain’s reusable packaging.
Kane Biotech donates revyve™ Antimicrobial Wound Gel to Ukraine, aiding the treatment of war-related injuries.
Agios finishes Phase 3 trial enrolment for Mitapivat, aiming to improve treatment of sickle cell disease.
Alphina Therapeutics names Nick Galli as CEO to lead the development of its promising NAMPT inhibitor for solid tumors.
Schreiner MediPharm and WuXi XDC create an innovative Light-Protect-Label for ADCs, ensuring drug safety in trials.
SwRI's new 21,000-square-foot facility will enhance its R&D for small-batch therapeutics, vaccines, and stem cell therapies.
United Therapeutics and Lung Bioengineering celebrate 500 EVLP lung transplants, advancing transplant access with innovative organ evaluation technologies.
NImmune Biopharma gains exclusive rights to develop and commercialize omilancor for I&I conditions in Asia, advancing Phase 3 trials for ulcerative colitis.
Evotec and Bristol Myers Squibb expand their partnership with a $50M investment to advance drug discovery using molecular glue technologies.
Merck acquires Modifi Biosciences for $30M, aiming to boost cancer therapies targeting DNA repair-deficient tumors, with up to $1.3B in milestones.
Merck’s CAPVAXIVE™ earns CDC ACIP recommendation for pneumococcal vaccination in adults 50+, enhancing protection against pneumonia.
Merck's Keytruda secures its 30th European approval, expanding into treatments for gynecologic cancers.
Rigel Pharmaceuticals issues safety advisory for GAVRETO to providers, stressing vigilance in cancer patient care.
Rhythm Pharmaceuticals partners with Axovia Therapeutics for research to better understand Bardet-Biedl syndrome.
AbbVie partners with Richter to discover and develop neuropsychiatric treatments, building on years of CNS research.
ImmunityBio begins trial in South Africa testing CD19 CAR-NK cell therapy for relapsed non-Hodgkin’s lymphoma.
Matica Biotechnology and KaliVir Immunotherapeutics team up to advance scalable viral vector production for cancer therapies.
Walgreens and Veeva Unite to transform pharma collaboration and enhance patient outcomes through integrated data solutions.
Coronado Research appoints Professor Jennifer Visser-Rogers as Chief Scientific Officer to advance clinical research.
Inozyme Pharma shares promising Phase 1 trial results for INZ-701 in ESKD patients at ASN Kidney Week 2024.
Rentschler Biopharma announces a record investment for a new buffer media station in Laupheim, enhancing production efficiency.
Fabhalta by Novartis demonstrates significant one-year benefits for C3G, showing sustained proteinuria reduction and improved kidney function.
Phathom Pharmaceuticals will present VOQUEZNA findings at the ACG meeting, exploring the efficacy of as-needed treatment for GERD relief.
Astellas pulls EMA application for ACP but remains committed to advancing GA treatment options across Europe.
AstraZeneca's Fasenra (benralizumab) receives EU approval for eosinophilic granulomatosis with polyangiitis, providing new hope for patients.
Recce Pharmaceuticals advances its Phase II ABSSSI trial for R327G, showing promising results for diabetic foot infections.
Lilly’s mirikizumab demonstrates sustained remission in UC and Crohn’s patients, with strong safety and symptom control.
Shuttle Pharma launches Phase 2 trial of Ropidoxuridine, aiming to enhance radiation treatment for glioblastoma patients.
Merck and Moderna launched Phase 3 of the V940 trial with KEYTRUDA, targeting non-small cell lung cancer patients post-surgery.
MIRA’s Ketamir-2 significantly outperforms gabapentin in preclinical chemotherapy-related neuropathic pain relief trials.
Monte Rosa licenses MRT-6160 and VAV1-targeting MGDs to Novartis for global development in immune-mediated diseases.
Chime Biologics partners with MedPacto to enhance biomanufacturing capabilities and advanced cancer therapeutics in South Korea.
Sai Life Sciences achieves FDA approval for Indian sites, reinforcing quality and compliance in global CRDMO operations.
Evoke Pharma, in partnership with EVERSANA, reveals GIMOTI's effectiveness in reducing healthcare visits for DGP patients.
AbbVie will acquire Aliada Therapeutics for $1.4 billion, focusing on innovative therapies for CNS diseases like Alzheimer’s.
CluePoints names Richard Young as Chief Strategy Officer to boost innovation in Risk-Based Quality Management.
First volunteers receive a long-acting injectable in a pivotal trial aimed at enhancing malaria prevention and combating this deadly disease.
Ryvu and nCage unite to create ADCs using TRAP cage tech, enhancing targeted cancer therapy safety and efficacy.
Naobios and Sumagen achieve a key production milestone for the SAV001 HIV-1 vaccine, moving closer to clinical trials.
Ardena announces a new bioanalytical lab in Oss and expands Assen's capabilities to support diverse drug development needs.
Merck invests €70M in St. Louis facility to triple ADC capacity, advancing targeted cancer and bioconjugate treatments.
In October 2024, WHO's Global Health Emergency Corps activates to aid 18 African nations in fighting mpox outbreaks.
Genascence appoints Dr. Jeymi Tambiah as the CMO, who brings extensive experience in gene therapy and clinical development leadership.
Shuttle Pharma's Phase 2 trial doses initial glioblastoma patients with Ropidoxuridine to boost radiation therapy outcomes.
Antheia achieves milestone with first commercial thebaine delivery, advancing resilient biomanufacturing for essential medicine production.
Resolian announces leadership changes, with Rob Stachlewitz as CEO, aiming to enhance global growth and innovation.
PharmaLogic opens a new radiopharmaceutical facility in Los Angeles, enhancing production and research to improve patient care and diagnostics.
Kiora Pharmaceuticals prepares Phase 2 trial of KIO-301 to explore vision restoration in patients with retinitis pigmentosa.
Celltrion debuts Steqeyma, its Stelara biosimilar, in Germany, planning broader EU expansion to boost market presence.
Volpara Health signs a $7.3M DHA contract to supply breast cancer screening software across U.S. military facilities.
CinFina Pharma’s CIN-109 and CIN-110 demonstrate strong Phase 1 results for weight reduction and appetite control.
Lokon Pharma and BeiGene team up in a Phase 2 trial to target pancreatic cancer with a new gene therapy combo.
Cytoki Pharma has begun Phase 2 trials for CK-0045, targeting obesity and type 2 diabetes, with results anticipated in 2026.
Tonix Pharmaceuticals teams with KEMRI to develop TNX-801 vaccine for mpox and smallpox, aiming for effective global response.
Alvotech & Advanz Pharma seek EMA approval for AVT05, a Simponi® biosimilar, promising cost-effective inflammatory care.
NeuroBo Pharmaceuticals finishes dosing in its Phase 2a study of DA‑1241 for Metabolic dysfunction‑associated steatohepatitis (MASH), an important step toward topline data expected in December 2024.
Scorpius partners with Celltheon to provide advanced cell line development, biomanufacturing services and scaling to GMP.
Alan Bash is appointed as the President of CARVYKTI® at Legend Biotech, leading commercial, technical, & quality operations.
Ascendis collaborates with Novo Nordisk and grants exclusive rights to TransCon tech for metabolic and cardiovascular drugs.
Conduit Pharmaceuticals secures patents for CDT1656, combining AZD1656 with a novel compound to target autoimmune disorders.
Syndax Pharmaceuticals has partnered with Royalty Pharma in a $350M synthetic royalty agreement for Niktimvo sales.
Catalyx and INEL unite to enhance pharmaceutical packaging with innovative automation, improving efficiency, compliance, and inspection processes globally.
CureVac N.V. appoints Axel Sven Malkomes as CFO, bringing 30 years of biotech finance experience to drive growth in mRNA therapies.
Synaffix collaborates with BigHat to advance ADC development, leveraging AI for antibody design and effective targeting.
Olon's Rodano facility for ultra-potent compounds will be operational by January 2025, ensuring safer API handling.
FUJIFILM Diosynth and TG Therapeutics partner for multi-year BRIUMVI® manufacturing, beginning operations in 2025.
Evotec SE divests Halle site to Monacum Partners, supporting core focus and growth strategy through "Priority Reset."
Acadia Pharmaceuticals sells Rare Pediatric Disease PRV for $150M, with proceeds supporting CNS and rare disease R&D. Neuren to receive one-third share.
Tarsus names Dr. Elizabeth Yeu as Chief Medical Officer, strengthening its commitment to advancing eye care innovation and patient outcomes.
FUJIFILM Diosynth starts global expansion, increasing production and creating 2,200 jobs to meet healthcare demands.
Legend Biotech's CARTITUDE-4 data at ASH 2024 shows CARVYKTI®'s superior MRD negativity in multiple myeloma patients.
iotaSciences launches advanced XT platform for automated single-cell cloning, aiding cell line development and gene editing.
WHO identifies 17 critical pathogens for new vaccine development, targeting major health burdens and antimicrobial threats.
Hanmi’s HM17321 obesity treatment targets fat reduction while preserving muscle, presenting a novel approach to metabolic health.
Pharos iBio’s PHI-101 demonstrates 50% complete response in AML phase 1 trial, targeting FLT3 mutation for potential early commercialization.
Dupixent® (dupilumab) is now approved in the EU for treating eosinophilic esophagitis (EoE) in children as young as one, offering a new treatment option.
The Access and Allocation Mechanism distributes 900,000 mpox vaccines to African countries, prioritizing highest-need regions.
Plus Therapeutics partners with SpectronRx to produce Rhenium (186Re) Obisbemeda for CNS cancer treatment.
Redwire, in collaboration with Eli Lilly, returns ISS-grown insulin crystals with potential to accelerate drug discovery.
I-Mab appoints Dr. Sean Fu as permanent CEO, bringing decades of life sciences and biotech expertise.
Acumen Pharmaceuticals announces the appointment of Dr. Amy Schacterle as Chief Regulatory Officer & Head of Quality to advance Alzheimer's therapies.
Cumberland's Ifetroban receives Orphan Drug and Rare Pediatric Disease designations for DMD-related cardiomyopathy treatment.
Kwality Pharma gains EU entry as Greece approves Leuprorelin, expecting $3M yearly sales from strategic CDMO deal.
Biosynth names Matt Gunnison CEO and Kieran Murphy Chairman to drive growth and innovation in life sciences.
Sonrai Analytics partners with MGH’s Termeer Center to integrate AI tech for faster, more efficient analysis of complex cancer research data.
Xilio’s vilastobart shows encouraging early data in treating MSS colorectal cancer, potentially targeting resistant tumors.
Mustang Bio’s MB-108, an HSV-1 oncolytic virus for malignant glioma, receives FDA Orphan Drug status, enhancing GBM treatment.
Kincell Bio appoints Stewart McNaull as CCO, enhancing its commitment to cell therapy innovation and client solutions.
CalciMedica appoints Stephen Bardin as CFO, bringing deep capital and finance expertise to advance company growth.
Aptar Pharma partners with CHI to launch Quattrii DPI, a platform aiming for efficient, high-dose respiratory drug delivery.
Geron raises $375M to advance RYTELO for blood cancers, supporting U.S. and EU launch, trials, and supply chain.
RNAi technology advances beyond liver treatments, with startups targeting CNS and genetic diseases using new delivery methods.
GC Cell partners with Artiva and Merck to advance two CAR-NK cancer therapies, assuming global R&D leadership rights.
Aurinia adds Craig Johnson to the Board of Directors, enhancing financial expertise as the company grows.
Collegium appoints Vikram Karnani as CEO. He brings leadership in rare disease pharmaceuticals and global expansion.
FDA reviews oral phenylephrine efficacy, proposing removal from OTC nasal decongestants. Public feedback is invited before a final decision. Learn more.
Grünenthal and Averitas Pharma complete enrollment for Phase III trial of QUTENZA® in post-surgical neuropathic pain, with results expected in 2025.
Biocon’s Bengaluru site receives FDA VAI status post-inspection, with minor issues not requiring regulatory action.
India’s ₹500 crore scheme aims to enhance local medical device manufacturing, reduce imports, and promote innovation.
Corvus presents promising data on ciforadenant's role in reducing immunotherapy resistance in metastatic prostate cancer.
GI Innovation's GI-101A and GI-108 show potential to enhance CAR-T therapy durability and counter tumour immunity challenges.
Merck strengthens its presence in Korea by investing in life sciences and semiconductors and forming a collaborative partnership with KAIST.
Swissport’s Madrid and Barcelona cargo centres receive GDP certification, boosting the global pharma logistics network.
Clarity teams with Nucleus RadioPharma to boost 67Cu-SAR-bisPSMA manufacturing and prepare for U.S. commercialization.
Recce Pharmaceuticals receives ethics approval to start a Phase 3 trial in Indonesia for R327G gel, targeting diabetic foot infections.
Boost immunity with Thymotas by Intas, featuring Thymoquinone. Clinically tested, it supports recovery, fights infections, and enhances overall immune health.
Indaptus’s Decoy20 platform combines innate and adaptive immune activation, showing promise for durable cancer therapy responses.
ARS Pharma licenses ALK exclusive rights to commercialise neffy, a needle-free epinephrine spray, in Europe, Canada, and geographies.
Pharma Two B and Hepion secure SEC approval for the merger, aiming to close in late 2024 pending shareholder vote.
RAPT Therapeutics halts the zelnecirnon program for asthma and dermatitis after the FDA holds the trials due to a severe liver injury case.
AbbVie’s Phase 2 EMPOWER trials for emraclidine in schizophrenia did not meet the efficacy target, while the safety profile was acceptable.
GenScript opens a logistics center in Sydney, improving delivery efficiency and supporting Australia’s biotech growth.
Longeveron appoints Devin Blass as CTO and Senior VP of CMC to lead technological and manufacturing strategies.
Citius Pharmaceuticals and Citius Oncology reveal promising Phase I trial results combining pembrolizumab with LYMPHIR™ for recurrent solid tumors.
Koneksa appoints Eric Luthi as Chief Business Officer, bringing 25+ years of life sciences expertise to lead business development and strategic partnerships.
Altimmune appoints Greg Weaver as CFO, bringing more than 25 years of experience in biotech finance and capital market expertise.
Syndax’s Phase 2 trial of revumenib for relapsed AML shows 23% remission and 47% response rate, with manageable side effects.
Spyre's SPY001, an α4β7-targeting antibody, shows promise for IBD with a 90+ day half-life, Phase 2 in 2025
Tempest Therapeutics advances to Phase 3 trial with FDA approval to test liver cancer drugs in combination therapy.
AstraZeneca and Daiichi Sankyo submit new BLA for EGFR-mutated lung cancer drug adjust trials based on FDA feedback.
Eagle Pharmaceuticals appoints Christopher Krawtschuk as CFO, succeeding Steven Ratoff, who remains on the board.
The KOMET trial demonstrates Koselugo's effectiveness for adult patients with inoperable plexiform neurofibromas in NF1.
Recursion's OpenPhenom-S/16 enhances microscopy data analysis in Vertex AI, aiding life sciences and drug discovery
Syros’ Phase 3 trial of tamibarotene with azacitidine fails to meet the primary endpoint for CR in HR-MDS patients, causing loan default.
Kane Biotech’s acquisition of FB Dermatology boosts wound care and skin treatment products in Europe, Australia, and the U.S.
AstraZeneca announces a $3.5B U.S. investment to expand R&D, manufacturing, and create 1,000+ jobs by 2026.
Longboard Pharmaceuticals launches Phase 3 trial of bexicaserin for seizures in Developmental and Epileptic Encephalopathies.
Rhythm’s setmelanotide trial shows BMI and hunger reduction in young children with genetic obesity syndromes, FDA review pending.
Tarsus Pharmaceuticals welcomes Dr. Kate Goodrich to its Board, bringing expertise in clinical leadership and health equity.
A new study shows diabetes cases have multiplied by four since 1990, with 800 million adults affected and treatment gaps in LMICs.
X4's study finds a daily mavorixafor safely raising ANC in chronic neutropenia, reducing G-CSF doses for many patients.
Zentalis Pharmaceuticals names Julie Eastland CEO and Scott Myers Board Chair as it advances azenosertib registrational studies.
Eli Lilly’s three-year study shows tirzepatide reduces type 2 diabetes risk, supports weight loss, and improves health markers.
Continuity Biosciences focuses on advanced cell reprogramming, immune modulation, and drug delivery to treat chronic diseases.
Pulmatrix and Cullgen merge to advance targeted therapies for cancer and more, with Cullgen to lead the combined company. Expected closure by March 2025.
TRexBio raises $84M in Series B to advance immune therapies, pushing innovative autoimmune treatments closer to clinical trials.
Affinia and Forge Biologics partner to manufacture gene therapies under cGMP, targeting heart and neuro diseases.
FDA grants approval for Kebilidi, a pioneering gene therapy to treat AADC deficiency, improving motor skills in young patients.
Corvus’s ITK inhibitor, soquelitinib, reduces fibrosis and lung damage in systemic sclerosis models, showing strong preclinical results.
Health Canada approves Kane Biotech's revyve™ Antimicrobial Wound Gel, granting immediate market access in Canada.
Merck enters an exclusive deal with LaNova for LM-299, with a $588M upfront payment and up to $2.7B in milestones.
Relmada Therapeutics initiates Phase 1 SAD trial to evaluate REL-P11 as a potential treatment for metabolic disease.
Omega Therapeutics updates include new leadership, strategic partnerships, and progress in clinical trials for innovative therapies.
Cellectar secures Ac-225 supply from NorthStar, driving CLR 121225 radiotherapy development for hard-to-treat cancers.
Cue Biopharma appoints Dr. Daniel Baker as interim CDO while Dr. Anish Suri transitions to a research advisor role.
FDA to review Dupixent® for chronic spontaneous urticaria, offering new hope for patients unresponsive to antihistamines.
Avantor's Bridgewater Innovation Center boosts biomanufacturing and accelerates life sciences therapies.
Amgen loses $12B in market value after hidden MariTide trial data reveals potential bone density concerns, rebounds later.
Boehringer Ingelheim adopts Veeva Vault CRM, enhancing agility and innovation across commercial operations.
Revuforj® gains FDA approval as the first menin inhibitor for leukemia with KMT2A translocation, launching November.
CHMP recommends KEYTRUDA for EU approval in MPM; KEYNOTE-483 shows improved survival with chemotherapy combination.
Dr Raymond Zheng joins Harbour BioMed as CBO, focusing on global partnerships and strategic product development.
PreveCeutical sells IP assets to BioGene in a USD $1.35M deal, including cash & shares, with plans to distribute shares to shareholders soon.
Neurophet names CTO Kim Dong-hyeon as Co-CEO, aiming to enhance R&D and global operations ahead of its planned IPO
Sanofi invests €40M in its Lyon site to boost antibody production, supporting transplant and type 1 diabetes treatments while advancing immunology.
Eyenovia’s CHAPERONE study misses the primary endpoint; the company considers mergers, asset sales, or other strategies.
Barinthus' HBV003 trial highlights VTP-300 and nivolumab's potential to deliver functional hepatitis B cures.
Arbutus' Phase 2a trial shows a 50% functional cure rate in HBV patients with low HBsAg, using imdusiran and Interferon.
China’s NMPA accepts Ascentage Pharma’s NDA for lisaftoclax, a novel Bcl-2 inhibitor for relapsed CLL/SLL treatment.
G20 leaders back WHO’s cervical cancer elimination campaign, highlighting global progress in vaccines, testing, and care equity.
Carisma unveils preclinical data on engineered macrophages, showing promise in tackling liver fibrosis and advanced MASH at AASLD 2024.
Tagrisso gains EU approval recommendation for EGFR-mutated NSCLC, with Phase III trials showing 84% reduced progression risk.
Alnylam's nucresiran achieves >90% TTR reduction with a single dose in Phase 1, showing promise for biannual/annual dosing in ATTR amyloidosis.
EC approves AbbVie's ELAHERE®, the first ADC targeting FRα, offering new hope for platinum-resistant ovarian cancer patients across Europe.
Island Pharmaceuticals' ISLA-101 trial hits a key milestone, exploring its potential as a treatment and preventative for dengue fever.
NeuroBo rebrands as MetaVia, advancing cardiometabolic drug pipeline with key trials in MASH and obesity set for 2024-2025.
Medicus Pharma appoints Dr. Faisal Mehmud as CMO. With 20+ years in clinical development, he’ll boost the company’s drug pipeline and strategic initiatives.
CPHI PMEC India 2024, Nov 26–28, Greater Noida, showcases global pharma trends, machinery, and tech innovations.
Medexus completes pCPA negotiations for Trecondyv®, aiming to secure public drug plan availability for Canadian patients.
Eli Lilly’s muvalaplin reduces Lp(a) by 85.8% in Phase 2, offering a promising oral option for heart disease.
AbbVie’s ELAHERE® approved in the EU for FRα-positive platinum-resistant ovarian cancer, showing survival benefits.
Ratio Therapeutics collaborates with Novartis on SSTR2-targeting radiopharmaceutical for cancer, worth $745M.
Dogwood reveals IMC-2 reduces Long-COVID fatigue at low doses; high doses cause GI side effects, limiting efficacy.
Preclinical results for Silo Pharma's SPC-15 reveal enhanced efficacy for depression via dual-receptor targeting therapy.
HCW Biologics partners with WY Biotech in a global agreement to develop and commercialize a novel immunotherapy.
Min Park named Chief Commercial Officer at Matica Bio, leveraging 25+ years of experience in global life sciences.
IDEAYA Biosciences names Stu Dorman as Chief Commercial Officer, bringing 20+ years of oncology expertise to lead its commercial efforts.
Sapio Sciences partners with Waters Corporation to boost lab efficiency and data accuracy through LC-MS and LIMS integration.
Sakura and MEDIPATH partner to improve cancer diagnostics in France using automated Tissue-Tek AutoTEC® a120 systems.
Scorpius Ventures supports biotech firms with cGMP services and equity stakes, boosting U.S. biologics production.
ImmunityBio's ANKTIVA-BCG therapy achieves a 71% complete response rate in bladder cancer, with durable responses reaching 54 months.
Abzena launches GMP cell-based potency assays in UK and US, boosting bioassay services for biopharmaceutical development.
Mirai Bio appoints Jens Vogel, Ph.D., as President and COO to accelerate genetic medicine development and in vivo delivery systems.
Steritas and argenx collaborate to use STOX® Suite in trials, addressing steroid toxicity in autoimmune disease treatments.
Merck's subcutaneous pembrolizumab shows noninferiority to intravenous KEYTRUDA in efficacy and safety for metastatic NSCLC.
Simon Fry joins Conduit Pharmaceuticals' Board, bringing over 30 years of experience in investment banking.
Circio partners with Certest Biotec to formulate circVec-LNPs for tissue-specific gene therapy targeting genetic diseases.
Asimov partners with RevOpsis to advance RO-104, a tri-specific biologic targeting retinal vascular diseases.
The Recursion-Exscientia merger combines AI expertise to advance drug discovery, expanding clinical and preclinical pipelines.
Capricor's deramiocel receives Orphan drug and ATMP designations, boosting the development of Duchenne muscular dystrophy therapy.
Voyager selects VY1706 for Alzheimer’s, with promising tau reduction results in preclinical NHP studies.
Pfizer names Dr. Chris Boshoff as Chief Scientific Officer and R&D President, effective January 2025, succeeding Dolsten.
Ziihera gains FDA acceptance for HER2-positive BTC; Phase 2b data show a 52% response rate and confirmatory trials are in process.
Samsung Biologics announces USD 668M in contracts, expands ADC services, and plans a new Bio Campus II.
BIMZELX (bimekizumab) receives FDA approval for moderate-to-severe hidradenitis suppurativa treatment in adults.
WHO announces ethical principles for managing genomic data, emphasising informed consent, equity, and transparency.
Alloy Therapeutics and Takeda partner to advance iCAR-T and iCAR-NK cell therapies for cancer treatment using iPSC technology.
Pfizer's HYMPAVZI™ wins EU nod as the first anti-TFPI therapy for severe hemophilia A & B, enabling once-weekly dosing with an auto-injector.
Syntegon achieves SBTi validation for climate goals, aiming for 48.3% Scope 1 & 2 emissions reductions by 2030 and greener operations.
Amneal progresses with FDA resubmission for migraine autoinjector and approval of exenatide for type 2 diabetes.
Protagonist advances PN-881, an oral IL-17 antagonist, into preclinical studies for immune-driven skin conditions.
Conduit Pharmaceuticals earns Japan patent for AZD1656, advancing its portfolio of autoimmune disorder treatments
CNSide CSF Assay detects biomarker changes in LM patients, the data to be presented at SNO 2024 in Houston.
Novartis acquires Kate Therapeutics for $1.1B to enhance gene therapies targeting neuromuscular diseases.
Genpact renewed its partnership with Ferring to streamline finance, accounting, and procurement, including AI.
Vetter appoints three senior leaders to its management team to drive sustainable growth and meet global customer needs, starting January 1, 2025.
Transposon Therapeutics acquires nucleoside analogs from PrimeFour, boosting its oncology pipeline with potential for targeted cancer treatments.
Dr. Reddy's names Vaibhav Rane as Head of Project Management at R&D Centre to optimize product strategies.
Merck welcomes Emerson’s CEO, Surendralal Karsanbhai, to its board, further strengthening its leadership team in 2025.
CNSide’s FORESEE trial shows superior accuracy and treatment impact for breast and lung cancer patients with LM.
Globus Medical’s ExcelsiusHub™ revolutionises spine surgery with real-time navigation, imaging flexibility, and safety features.
Merck’s WELIREG gains approval in China for VHL disease, demonstrating significant tumour response in critical trials.
Japan expands approval for GSK’s Arexvy, allowing use in adults 50-59 at high risk of severe RSV disease.
Gattefossé opens a state-of-the-art Mumbai Technical Center, advancing pharmaceutical and personal care R&D in India.
Kim Kyung-jin joins Samyang as biopharma president, driving CDMO expansion and advancing mRNA delivery technologies.
Firebrick partners with Guardian to make Nasodine available in 121 pharmacies, including Changi Airport outlets.
Truqap (capivasertib) with abiraterone and ADT boosts survival in PTEN-deficient prostate cancer, showing promising results in a Phase III trial.
Ascentage Pharma appoints Marina S. Bozilenko and Dr. Debra Yu as Independent Non-Executive Directors to enhance governance and support growth.
Hanmi's BH3120 immunotherapy, targeting PD-L1 and 4-1BB, shows promise in Phase 1 trials for solid tumors.
Pharma Now proudly announces its media partnership with Evolution Summit 2024, spotlighting pharma industry innovation.
Qosina names Lee Pochter as CEO, with Scott Herskovitz continuing as Chair and Medical Division President.
Lee Patterson named CEO of Metrion Biosciences, focusing on growth and global presence as Dr. Andrew S. steps down.
Delegates unite at WHO’s first oral health summit to address global challenges and ensure balanced care access.
Eton Pharmaceuticals secures U.S. rights to Amglidia for neonatal diabetes, aiming for FDA approval by 2026.
iiCON leads a £3.2M trial for PnuBioVax, tackling resistant pneumococcal strains like SPN3 to combat global health and antimicrobial resistance.
Citius Pharma advances Mino-Lok program post-FDA Type C meeting, aiming for NDA submission after pivotal Phase 3 success.
Merck reports vital Phase 3 ZENITH trial results for WINREVAIR in pulmonary arterial hypertension (PAH).
Arlington Capital Partners acquires TEAM Technologies, enhancing healthcare manufacturing and strategic supply solutions.
Dr. Deyaa Adib joins AffyImmune as CMO, bringing decades of oncology expertise to advance (CAR) T therapies.
IGC Pharma reports Phase 2 interim data showing IGC-AD1 reduces agitation and enhances cognition in Alzheimer's trials.
Biohaven’s taldefgrobep shows motor function and fat mass benefits in SMA, with potential for obesity treatment progress.
Freudenberg strengthens its commitment to India with innovative product launches at CPhI & PMEC 2024, driving industry growth.
Island Pharmaceuticals’ ISLA-101 shows safety and antiviral activity in Phase 2a dengue trial, with Phase 2b set to start in January 2025.
Dr. Reddy's, in collaboration with Senores Pharmaceuticals, introduces Ivermectin 3 mg tablets in the U.S. market.
Shuttle Pharma launches Phase 2 trial of ropidoxuridine, targeting improved radiation therapy outcomes for glioblastoma.
Afatinib, combined with DFP-14323, receives a seal of approval in Japan's 2024 guidelines for NSCLC therapy.
Tillotts Pharma and Pioneer Pharma team up to distribute Asacol® 800mg in China, addressing the rising prevalence of ulcerative colitis.
Roche announces SKYSCRAPER-01 trial results, with tiragolumab plus Tecentriq missing the overall survival endpoint in PD-L1-high NSCLC.
Acadia signs a global licensing deal with Saniona to develop SAN711 for essential tremor, aiming for Phase 2 trials in 2026.
Nexus Pharmaceuticals secures FDA approval for Methylene Blue Injection to treat methemoglobinemia, enhancing access to life-saving medication.
KalVista Pharmaceuticals appoints Laurence Reid, Ph.D., to its Board, bringing expertise in biotech growth, innovation, and strategic leadership.
Exelixis announces FDA review of CABOMETYX for advanced pNET and epNET, based on phase 3 CABINET trial data, at ODAC in March 2025.
Roche acquires Poseida Therapeutics to boost development of next-gen off-the-shelf CAR-T therapies, targeting oncology, immunology, and neurology.
Outlook Therapeutics reveals NORSE EIGHT trial results, showing vision improvement and safety, with a BLA resubmission planned for Q1 2025.
Glenmark introduces Travoprost Ophthalmic Solution, bioequivalent to Travatan Z®, enhancing its U.S. product portfolio.
Prelude Therapeutics will participate in the JMP Hematology and Oncology Summit, featuring a webcast fireside chat.
Syndax CEO Michael Metzger to discuss novel oncology mechanisms during the Citi 2024 Global Healthcare Conference panel.
BioStem signs a Letter of Intent to acquire revyve™ Wound Gel and technologies from ProgenaCare and Kane Biotech.
Carisma Therapeutics' CEO Steven Kelly to join a fireside chat at the 7th Annual Evercore ISI HealthCONx Conference on December 5th.
Amylyx Pharmaceuticals announces participation in the 7th Annual Evercore ISI HealthCONx Conference on December 4, 2024.
ADVANZ PHARMA reacts to the European Commission revoking OCALIVA® approval for PBC treatment in Europe.
Perspective Therapeutics to present at Piper and Evercore HealthCONx conferences, highlighting cancer treatment innovations and growth strategies.
Novartis gains EC approval for Kisqali® in HR+/HER2-early breast cancer, offering a new option to reduce recurrence risk in high-risk patients.
Nemolizumab shows significant improvements in itch, skin lesions, and sleep in prurigo nodularis, earning FDA approval as Nemluvio®.
Dev4All collaborates with Pharmaseed to integrate expertise to provide comprehensive preclinical drug development solutions.
Telix & Grand Pharma dose first patient in the Phase III ZIRCON-CP trial of TLX250-CDx PET imaging for kidney cancer at Beijing Cancer Hospital.
Dr. Reddy’s launches Toripalimab in India, advancing RM-NPC treatment with immuno-oncology innovation.
Innovent adds SINTBILO® and olverembatinib to China's NRDL, expanding cholesterol and CML care options.
The WHO confirms mpox as a public health emergency, emphasising coordinated international efforts and resources.
Lupin receives FDA approval for Sitagliptin and Metformin tablets, a generic Janumet®, enhancing diabetes care options.
Huons Biopharma partners with VERNI Aesthetics to commercialize MRC101, a fat decomposition injection, boosting its aesthetics portfolio and R&D efforts.
Bayer opens Co.Lab Berlin, a life science incubator, with MyoPax as its first resident, boosting biotech innovation and muscle regeneration research.
Silo Pharma collaborates with Kymanox to develop a ketamine implant and insertion device aimed at treating chronic pain and fibromyalgia.
WHO highlights critical gaps in preventing healthcare-associated infections, urging stronger IPC measures to protect patients and healthcare workers.
Evotec announces COO Dr Craig Johnstone's step down by December 2024; operations will be restructured internally.
ABIONYX adopts vital resolutions, including new director appointments and bylaw changes, at its 2024 General Meeting.
Nanolek and GC Biopharma seek approval for trials of a new chickenpox vaccine, aiming for registration by 2027.
Afreximbank and Med Aditus partner to build a $40M pharma plant in Kisumu, boosting medicine production in Kenya.
Nirmala Sitharaman calls for India to establish pharma standards, scale global innovations, and embrace an Indian identity.
NEXT BIOMEDICAL secures U.S. FDA approval for Nexpowder's use in treating lower GI bleeding, expanding its scope.
Brainomix earns LSX and OBN honors for its AI imaging platform, driving advances in stroke care and lung fibrosis treatment worldwide.
CBC Group and Mubadala acquire UCB's neurology and allergy assets in China, launching NeuroGen Pharma for growth.
Experience 12x faster MRI scans with GE HealthCare’s Sonic DL for 3D, enhancing imaging for neurology, orthopedics, and body exams.
Everest Medicine’s VELSIPITY® NDA accepted in Hong Kong for treating moderately to severely active ulcerative colitis.
FDA approves Biocon Biologics' YESINTEK™, a Stelara® biosimilar for Crohn's, Ulcerative Colitis, psoriasis, and arthritis.
Bayer highlights AI advancements, low-dose contrast agents, and smart imaging systems at RSNA 2024, enhancing radiology workflows and patient care.
GE HealthCare introduces AI-powered technologies at RSNA 2024, aimed at improving radiology workflows, boosting efficiency, and enhancing patient care.
Merus will present updated data on petosemtamab for r/m HNSCC at ESMO Asia Congress 2024, Singapore.
Novocure’s Phase 3 PANOVA-3 trial shows TTFields therapy improves survival in pancreatic cancer, with 2-month advantage over standard chemo.
Medicus Pharma teams up with Swanielle Inc. to expand its Phase 2 BCC clinical trial into Asia-Pacific, accelerating global skin cancer treatment.
Mapi Pharma presents innovative Depot technologies at Evercore HealthCONx 2024, offering partnership opportunities for long-acting injectable treatments.
Orexo AB and GAIA AG end their Deprexis® partnership for the U.S., impacting Q4 2024 income but maintaining cash position and future profitability.
Eckert & Ziegler launches Ac-225 production, addressing shortages and paving the way for clinical radiopharmaceutical use.
IntegriChain presents at Trade & Channel Strategies, exploring pharma trends and AI-powered distribution insights.
PTC and Novartis partner on Huntington’s therapy, with $1B upfront, milestone payments, and U.S. profit-sharing.
Rigel’s R289 secures FDA Fast Track for transfusion-dependent lower-risk MDS, aiming to address unmet needs with its dual IRAK1/IRAK4 inhibitor.
TORL BioTherapeutics names Dr. Aran Maree as CMO and launches a Phase 2 trial for TORL-1-23 in CLDN6+ platinum-resistant ovarian cancer.
Medexus revises milestone payments for treosulfan, anticipates FDA approval by Jan 2025, and strengthens financial flexibility for U.S. launch.
AC Health collaborates with USAID to improve HIV care in the Philippines, expanding telehealth, testing, and access to essential medications nationwide.
Spyre initiates Phase 1 studies of anti-TL1A antibodies, with safety and pharmacokinetics data expected in 2025.
Eckhard Niemeler joins Nouscom as Chief Business Officer, bringing 20+ years of expertise in life sciences leadership.
Novo Nordisk presents groundbreaking data on sickle cell disease and hemophilia treatments at ASH 2024, focusing on unmet needs in rare blood disorders.
Jazz Pharmaceuticals showcases oncology and hematology data at SABCS and ASH 2024, focusing on HER2-positive cancers and blood disorders.
Keros licenses elritercept to Takeda for global development, focusing on anaemia and rare blood disorders.
Plus Therapeutics and IsoTherapeutics extend the partnership, ensuring scalable production of cGMP Re-186 for key treatments.
Recursion launches a trial for REC-1245, an AI-discovered therapy targeting biomarker-enriched tumours and lymphoma.
Lawrence Kenyon becomes Interim CEO of Outlook Therapeutics after Russell Trenary steps down from the role.
Martin Pharmaceuticals partners with Mitsubishi Tanabe for exclusive access to docarpamine data for GI conditions outside Japan.
Romaco Holding GmbH appoints Ann-Xiaoyan Li as Group CFO & Managing Director, overseeing finance, HR, IT, and operations to drive growth and efficiency.
Coeptis Therapeutics to acquire NexGenAI's AI marketing platform, boosting efficiency in biotech and pharma.
Ipsen and Biomunex collaborate on BMX-502, a bispecific antibody using MAIT cells to target cancer, offering safer, innovative immunotherapy solutions.
AstraZeneca appoints Iskra Reic as EVP for International, overseeing strategy and growth across key markets, including Asia, China, and Latin America.
Jazz will discuss Ziihera® approval, clinical trial data, and commercialisation plans in the upcoming webcast.
Corvus highlights soquelitinib’s mechanism to boost tumour immunity, with Phase 3 and Phase 1 trials underway for various uses.
X4 Pharmaceuticals will present Mavorixafor trial-in-progress data poster and preclinical data at the 2024 ASH Meeting, December 7-10.
Franklin Biolabs appoints Dr. Vatsala Naageshwaran as CEO, bringing over 20 years of experience in advancing gene therapy and biopharmaceutical operations.
Circio unveils circVec 3.0, a circular mRNA lasting 75x longer than linear mRNA, transforming nucleic acid medicine durability and safety.
Nxera Pharma announces Phase 3 trial of daridorexant for insomnia treatment in South Korea, with results expected by 2026.
Vincerx Pharma cuts costs to advance VIP943 Phase 1 study, focusing on innovative cancer treatment with its ADC therapy.
Atea Pharmaceuticals announces successful Phase 2 trial results for HCV treatment, paving the way for Phase 3 trials in early 2025.
Amylyx Pharmaceuticals initiates a Phase 3 trial for avexitide to treat post-bariatric hypoglycemia, building on promising Phase 2 study results.
Bayer and Liveo Research unveil innovative blister packaging with a reduced environmental footprint, setting new industry standards.
Plus Therapeutics will present Phase 1 ReSPECT-LM data at the 2024 San Antonio Breast Cancer Symposium, focusing on Rhenium Obisbemeda for LM treatment.
Merck starts Phase 3 clinical trial for LAGEVRIO, evaluating its effectiveness in high-risk COVID-19 patients to prevent severe disease.
Monte Rosa shares interim data from the MRT-2359 trial in MYC-driven cancers, highlighting safety, dosing, and pharmacodynamics.
Charles River announces its Incubator Program to support early-stage biotech companies in advancing therapies and innovation.
Theriva gains FDA input on Phase 3 study design for VCN-01 in combination with chemo for pancreatic cancer.
PDF Radiopharma announces Techne® Pyrophosphate Injection’s listing on Japan’s NHI, with a launch scheduled for February 2025.
Novartis announces positive results from Phase III3B APPULSE-PNH study of Fabhalta® in PNH patients switched from anti-C5.
FDA grants Imfinzi approval for LS-SCLC, offering improved survival rates and marking a major advance in treating this aggressive cancer.
MaaT Pharma treats its first U.S. aGvHD patient with MaaT013 under compassionate use, marking progress in life-saving microbiome therapies.
ProBio names Allen Guo as CEO, Whitney Winters as SVP, and Michael Vreeland as U.S. Site Head to drive innovation in advanced therapies.
Teva is selling its stake in the Teva-Takeda venture in Japan to JKI as part of its Pivot to Growth strategy, with completion expected by April 2025.
NorthStar and PDRadiopharma collaborate to advance innovative radiopharmaceuticals for clinical trials and cancer care.
FDA accepts Priority Review for Imfinzi in MIBC, with Phase III data showing reduced progression and improved survival.
Lupin secures FDA approval for its pediatric HIV treatment, a generic version of Triumeq PD®, made in Nagpur.
Torii submits NDA for TO-208 in Japan, marking progress toward the first approved molluscum contagiosum treatment.
Novo's Catalent acquisition gets EU approval; final steps and regulatory clearances are expected by year-end 2024.
WHO selects experts worldwide to update guidelines on advanced HIV care, focusing on CD4 testing and treatment strategies.
Enanta Pharmaceuticals announces December 9 webcast to share topline Phase 2 RSV study results in pediatric patients.
Jazz Pharmaceuticals presented new data at AES 2024, showing Epidiolex® improves seizure control and behavior in TSC and epilepsy patients.
Dr. Reddy's appoints Chiranjoy Chowdhuri as Head of Data and AI CoE to drive digital transformation and AI initiatives, enhancing business impact and growth.
Five-year POLARIX data highlights Polivy + R-CHP efficacy in DLBCL, reducing death risk and enhancing remission durability.
Calquence with venetoclax achieves better survival and safety outcomes than chemoimmunotherapy in CLL patients.
Leukogene appoints Dr. Gupta as CEO, leveraging his oncology expertise to drive its MT2™ platform for "cold" tumors.
Merck’s zilovertamab vedotin, in combination with R-CHP, hits 100% complete response rate in a Phase 2 trial for untreated DLBCL treatment.
AbbVie highlights emotional and cultural challenges among diverse CLL patients, emphasising gaps in support and communication.
Recce secures approval in Indonesia for a Phase 3 trial of RECCE® 327 Gel, advancing treatment for diabetic foot infections.
Tonix's TNX-102 SL, a sublingual cyclobenzaprine, shows promise in improving pain, sleep, and symptoms for fibromyalgia.
Hikma debuts FDA-approved Furosemide Injection in 50mL and 100mL forms, enhancing its U.S. injectable offerings.
Seres' FDA-designated SER-155 reduces bloodstream infections in allo-HSCT patients, showing transformative potential.
GSK's Nucala shows promise as an add-on therapy for COPD with eosinophilic phenotype, based on MATINEE study.
AbbVie reports positive Phase 3 results for tavapadon, a once-daily treatment for early-stage Parkinson's disease.
Enanta reports Phase 2 success for zelicapavir, showing strong antiviral effects and safety in RSV pediatric study.
Acurx advances ibezapolstat into Phase 3 trials for C. difficile, focusing on efficacy, safety, and recurrence prevention.
Syndax shares positive trial results for Revuforj in AML, including its use in combination therapies for new patients.
Recursion's Phase 1 data highlights REC-617's potential as a best-in-class CDK7 inhibitor for advanced solid tumors.
CARVYKTI® achieves 89% MRD negativity in relapsed multiple myeloma, showcasing transformative potential in the CARTITUDE-4 study.
Carisma shifts focus to its macrophage engineering platform, halting CT-0525 development and reducing the workforce.
Acadia names Thomas Garner as CCO to drive growth and promotes Holly Valdiviez to lead the NUPLAZID franchise.
Cellipont adopts Xiogenix's Ares™ X20, enhancing automation, scalability, and precision in cell therapy production.
Emmes names Bryan Patterson as Senior Vice President to drive growth and innovation in U.S. government clinical research efforts.
Cipher evaluates MOB-015 trial findings while prioritizing Natroba™ integration and future growth initiatives in key markets.
FDA clears Astria Therapeutics’ STAR-0310 IND for clinical trials targeting atopic dermatitis and other conditions.
Sound Pharmaceuticals' SPI-1005 Phase 3 trial achieves hearing and speech improvements for Meniere's disease patients.
CPHI & PMEC India 2024 attracts 50,000+ attendees and 2,000 exhibitors, showcasing pharma innovation globally.
Arvinas and Pfizer present promising Phase 1b data on vepdegestrant and abemaciclib for breast cancer at San Antonio Breast Cancer Symposium 2024.
aTyr Pharma's Phase 3 EFZO-FIT™ study on efzofitimod for pulmonary sarcoidosis progresses unchanged by DSMB.
Zealand Pharma enrolls first participant in ZUPREME-1 trial, testing petrelintide for obesity and weight-related conditions.
Ketamir-2 by MIRA achieves preclinical safety milestone, paving the way for trials targeting neuropathic pain in 2025.
Baxter's 2024 launches include injectables for infections, cancer, GERD, seizures, enhancing efficiency and safety.
Pharma Now’s Nov-Dec edition explores pharma machinery breakthroughs, leadership insights, and coverage from key industry events.
AbbVie completes the acquisition of Aliada, focusing on ALIA-1758, an Alzheimer's drug with CNS-targeting technology.
Astria’s STAR-0215 shows 90-95% attack reduction in HAE trial, entering Phase 3 in 2025 with strong safety results.
Phathom seeks FDA approval to extend VOQUEZNA tablets' market exclusivity to 2032, citing NCE provisions under GAIN.
OlympiA trial confirms Lynparza improves survival and reduces recurrence in high-risk breast cancer patients.
Acadia’s PRV sale of $150M focuses on investing in operations, primarily in R&D, commercial operations, and future growth opportunities.
Hepion Pharmaceuticals cancels merger with Pharma Two B Ltd. and withdraws December 12 stockholder meeting.
Monte Rosa teams up with Novartis to advance VAV1-targeted molecular glue degraders, including MRT-6160, for immune diseases.
Prelude's PRT2527 shows preliminary activity and acceptable safety in relapsed/refractory lymphoid malignancies.
Conduit partners with SARBORG to integrate AI and cybernetics, boosting efficiency in drug discovery and trials.
FLOW trial shows Ozempic® cuts CKD progression, cardiovascular risks, and mortality, earning EMA's CHMP approval.
Zentalis Pharmaceuticals appoints Wendy Chang as Chief People Officer and Haibo Wang as Chief Business Officer to drive innovation in cancer therapies.
Amar Urhekar takes over as CEO of Avalere Health, aiming to drive innovation in healthcare solutions
Keros holds high-dose TROPOS trial arms due to safety review; 1.5 mg/kg dosing continues, data in Q2 2025.
Medicus Pharma receives FDA MUMS status for D-MNA to treat horse cancer, granting 7-year exclusivity.
IBRANCE® boosts progression-free survival by 15+ months in HR+/HER2+ metastatic breast cancer, per Phase 3 PATINA trial at SABCS 2024.
Ascendis Pharma's sBLA for TransCon hGH in adult GHD was accepted by the FDA, with a decision due July 2025.
ARS Pharma's neffy nasal spray sees approval filings in China, Japan, and Australia after U.S. and EU success.
Takeda highlights its late-stage pipeline, featuring breakthrough therapies and key Phase 3 data expected in 2025.
Novo Nordisk finalises plans to acquire three Catalent sites, prioritising strategic investments over buybacks in 2025.
Glenmark debuts Lacosamide Oral Solution, generic for Vimpat®, growing its U.S. portfolio with 201 approved products.
CHMP recommends advancing affordable healthcare access, including Celltrion’s biosimilars, Eydenzelt, Stoboclo, Osenvelt, and Avtozma.
SK plasma partners with Janssen Korea to distribute Velcade, bolstering its portfolio of cancer treatment options.
Novo Nordisk invests DKK 8.5B in a sustainable Odense facility, creating 400 jobs and advancing rare disease treatments by 2027.
GSK’s Jemperli gets FDA Breakthrough Designation for rectal cancer, showing 100% clinical response in 42 patients.
Thermal Energy inks $2.8M deal with pharma leader, enhancing efficiency and cutting emissions by 728 tons annually.
Reviva’s brilaroxazine shows sustained efficacy, strong safety, and tolerability in 1-year Phase 3 schizophrenia trial.
Merck’s KEYTRUDA is approved in China for stage II-IIIB NSCLC, combining chemo pre-surgery and monotherapy post-surgery.
Foghorn Therapeutics stops independent development of FHD-286 in AML; prioritises pipeline and Lilly collaboration programs.
Xilio Therapeutics names Caroline Hensley as Chief Legal Officer, bringing extensive legal and compliance expertise to the team.
Jazz CEO Bruce Cozadd announces retirement by 2025; Board starts search for a successor as Cozadd remains Board Chair.
GSK'227, a B7-H3-targeted ADC, receives EMA PRIME Designation for treating relapsed extensive-stage SCLC.
Innovent and Lilly expand partnership to distribute and promote Jaypirca® for mantle cell lymphoma in Mainland China.
Single Use Support names Darren Verlenden as CEO to drive global growth and innovation in biopharma solutions.
Jim Scibetta takes the helm as CEO of VectorY Therapeutics, advancing ALS therapy VTx-002 into clinical trials and expanding the company's U.S. presence.
United Therapeutics achieves first living human UKidney transplant, advancing organ supply through genetic engineering.
Tonix's TNX-102 SL receives FDA acceptance for fibromyalgia treatment, backed by positive Phase 3 trial results.
Merck's clesrovimab aims to protect infants from RSV; FDA decision expected by June 2025 after positive trial data.
Evergen, formerly RTI Surgical, advances as a CDMO pioneer, offering allograft and xenograft biomaterials at scale.
Portage Biotech signs a letter of intent with Immunova for potential acquisition of iOx Therapeutics, advancing PORT-2 development.
Regeneron’s EYLEA HD shows non-inferior results in RVO treatment; FDA submission is planned for early 2025.
EVA Pharma's insulin glargine gets Egyptian Drug Authority approval, advancing diabetes treatment in underserved regions.
Corvus Pharmaceuticals will announce Phase 1 results for soquelitinib in atopic dermatitis on December 18, 2024.
Marker Therapeutics receives a $9.5M CPRIT grant to advance MT-601 for metastatic pancreatic cancer, and clinical trials are set for 2025.
Dr. Marc Damelin joins Alphina as CSO, bringing expertise to advance its NAMPT inhibitor targeting solid tumors.
Russia’s mRNA cancer vaccine, set for 2025, shows early success in tumor suppression and metastasis reduction.
Borosil Renewables plans ₹675-crore Indian expansion, ₹700-crore fundraising, and adjusts German operations amid challenges.
Merck partners with Hansoh Pharma, securing global rights to HS-10535 for cardiometabolic advancements and therapies.
Silo Pharma initiates a study on SP-26, a ketamine-based injectable implant targeting chronic pain and fibromyalgia treatment.
Agios' mitapivat receives orphan designation in the EU for sickle cell disease, promising innovative treatment options.
Corvus shares interim data showing soquelitinib's safety and efficacy in treating moderate atopic dermatitis.
MetaVia's DA-1241 significantly reduces ALT, HbA1c, and CAP levels in the Phase 2a trial for MASH, showing strong potential.
Nxera Pharma and Shionogi launch QUVIVIQ™ in Japan, offering a new treatment for insomnia relief in adults.
Prasinezumab shows potential in slowing Parkinson's progression, with further analysis and trials ongoing.
Adicet Bio appoints Dr. Julie Maltzman as Chief Medical Officer, advancing its pipeline in oncology and autoimmune diseases.
CPHI & PMEC India 2024 concluded with record-breaking attendance, highlighting cutting-edge pharma innovations.
Macron and WHO launch the WHO Academy in Lyon to train health leaders and address the global healthcare workforce gap.
Shuttle Pharma partners with UCSF to develop PSMA-B, a theranostic agent redefining prostate cancer care and treatment.
MT-601 by Marker Therapeutics achieves 78% response in Phase 1 lymphoma trial, offering hope for relapsed patients.
Hikma secures rights to 17 Takeda brands in MENA, ensuring supply stability and enhancing profitability.
PTC submits vatiquinone NDA to the FDA for treating Friedreich ataxia in children and adults with strong efficacy and safety data.
Vertex reports Phase 2 success for suzetrigine, demonstrating meaningful pain reduction and a strong safety profile in LSR.
Merck’s Phase 3 results confirm DOR/ISL’s efficacy and safety for HIV-1, with plans to present findings and file data.
Lifecore Biomedical partners with Nirsum Labs advance NRS-033, a promising treatment for opioid and alcohol addiction, leveraging sterile injectable expertise.
Neffy, the first FDA-approved epinephrine nasal spray, ensures broad access via Express Scripts’ formularies.
Ascendis Pharma’s YORVIPATH delivers 24-hour PTH exposure for adults with hypoparathyroidism, transforming care.
AIOCD delegation visits AXA & Heilsa plants, applauding commitment to high-quality, affordable medicines in India.
Regeneron’s Phase 2 trials show promising results for Factor XI antibodies with strong safety profiles in anticoagulant treatment.
Xilio shares plans to present Phase 2 vilastobart data in MSS CRC at ASCO GI 2025, highlighting treatment progress
Merck secures global rights for LM-299 with LaNova Medicines, investing $588M upfront and $2.7B in milestones.
GSK’s phase III trial finds that the Zejula and Jemperli combo boosts Progression-Free Survival in advanced ovarian cancer; safety aligns with expectations.
BioAtla secures $9.2M via direct offering to fund clinical trials for TCE and ADC therapies in solid tumours.
Hikma introduces Indomethacin Suppositories (50mg) in the US for arthritis, gout, and acute painful shoulder.
Novo Nordisk’s REDEFINE 1 trial finds CagriSema achieves significant weight loss and is well-tolerated in obesity treatment.
Organon Korea's Oh So-yun assumes Country Lead role in Malaysia, advancing growth in women's health and chronic care.
VaxCell-Bio collaborates with Bio Design Lab to advance CAR-NK cell therapies, offering safer and cost-effective solutions.
GI Innovation launches a phase 1 trial for GI-102, a subcutaneous immune-oncology drug targeting melanoma.
SK Bioscience partners with Sanofi on next-gen pneumococcal vaccines, targeting children, adults, and unmet global needs.
Celltrion secures Korean approval for Avtozma, its Actemra biosimilar, expanding its interleukin inhibitor portfolio.
RAPT acquires rights to RPT904, a long-acting IgE antibody, promising enhanced allergy treatment with global reach.
The WHO calls for greener pharmaceutical practices, urging sustainability in manufacturing, packaging, and distribution.
AstraZeneca’s Tagrisso is approved in the EU for treating advanced NSCLC with EGFR mutations post-CRT
Tonix's TNX-102 SL, a non-opioid for fibromyalgia, nears FDA approval with promising Phase 3 trial results.
Sanofi and SK Bioscience collaborate on next-gen pneumococcal vaccines, including PCV21, now in phase 3 trials
Luxembourg pledges €47.5M to WHO for health crises, equity, and SDG goals, marking a historic collaboration.
Porton and Dragon Sail join forces to revolutionize ADC development and accelerate drug availability worldwide.
Arrowhead launches clinical trials for ARO-INHBE, an RNAi obesity treatment, with ARO-ALK7 also progressing
GEMTESA earns FDA approval as the first β3 agonist for men with OAB symptoms linked to BPH, now available in the U.S.
OBI Pharma and GlyTech collaborate to advance ADC development, focusing on glycan production and cancer therapies.
AstraZeneca and Daiichi Sankyo withdraw EU application for datopotamab deruxtecan but affirm their commitment to progress.
Enanta Pharmaceuticals will appeal a court ruling favoring Pfizer in a patent dispute over COVID-19 antiviral Paxlovid.
Prothix LifeSciences partners with Oviya MedSafe to redefine global drug safety, clinical trials, and regulatory compliance.
Bio-Thera and Tabuk collaborate to bring BAT2206, a Stelara biosimilar, to Saudi Arabia, boosting healthcare accessibility.
Meiji Seika Pharma establishes Taiwan subsidiary, boosting healthcare solutions with REZUROCK and key therapies in Asia.
JR-441, JCR’s therapy for MPS IIIA, gains orphan drug status in Japan, bolstering global efforts for rare disease treatments.
MedMira’s Multiplo® TP/HIV test gains Health Canada approval, providing rapid, dual HIV/syphilis detection nationwide.
Qilu's QLS32015 demonstrates remarkable tumor response and tolerability in Phase I trials for relapsed multiple myeloma.
KIST's peptide-based eye drops for dry AMD reduce retinal degeneration, enhancing safety and patient adherence.
Phase 3 trial reveals gecacitinib's superior spleen reduction, symptom relief, and safety in myelofibrosis patients.
ENCell's new CDMO contract with a pharma leader highlights its GMP-certified excellence in biopharma production.
Axcelead and Astellas unite to leverage the DegLead™ Platform, driving innovation in targeted protein degradation.
Hikma debuts generic Liraglutide, a GLP-1 diabetes treatment, expanding affordable care for adults and children.
Elite Pharmaceuticals introduces a cost-effective generic Vyvanse® for ADHD, offering patients greater accessibility.
Kwality Pharmaceuticals achieves SAHPRA approval for Tamoxifen, advancing quality oncology treatment in South Africa.
Mankind Pharma collaborates with Innovent Biologics to introduce sintilimab, revolutionizing cancer treatment in India.
IDEAYA licenses SHR-4849 from Hengrui Pharma to advance treatment for DLL3-expressing solid tumors like SCLC and NETs.
Hikma's ePHEDrine Sulfate Injection in prefilled syringes treats anesthesia-related hypotension, enhancing care access.
RenovaroCube names Maurice van Tilburg CEO, driving AI-powered cancer diagnostics and multi-omics solutions.
reace launches Percuplasty™, a percutaneous system offering 3D bunion correction with smaller incisions, less pain, and quicker recovery.
Japan approves VYVDURA, a subcutaneous CIDP therapy enabled by Halozyme’s ENHANZE®, for at-home patient convenience.
Radiopharm partners with Lantheus to advance clinical development of Lantheus innovative radiopharmaceuticals in Australia targeting solid tumours.
Autonomix secures key patents for its precision nerve ablation tech, aiming to ease pain and explore cancer treatment potential.
FDA approves Opdivo Qvantig™ co-formulated with Halozyme’s ENHANZE®, offering faster subcutaneous administration and similar efficacy to IV Opdivo.
Polyrizon secures patents for C&C™ and T&T™ platforms, innovating nasal protection and effective drug delivery systems.
Chimerix submits NDA for dordaviprone in treating recurrent H3 K27M-mutant glioma, seeks priority review, and secures up to $30M loan.
Orion and Marinus end the European ganaxolone agreement. Marinus regains commercial rights, and Orion suspends launch preparations.
Axsome’s AXS-05 delays agitation relapse in Alzheimer’s, achieves key endpoints in Phase 3 trials, and earns FDA status.
Galera’s acquisition of Nova Pharmaceuticals adds a pan-NOS inhibitor to its pipeline, targeting resistant breast cancers.
Cocrystal Pharma extends its Phase 2a study for CDI-42344 after low H3N2 infection rates. The trial evaluates safety, efficacy, and PK.
Altamira advances RNA delivery with CycloPhore™, achieving strong circular mRNA transfection and protein expression, also filled a patent.
Oncotelic launches PDAOAI for biotech AI document search, enabling precise answers and decentralised governance via PDAO tokens.
ARsgen launches trial for KJ-C2219, an allogeneic CAR T-cell therapy targeting CD19/CD20, in relapsed/refractory B-NHL patients.
Yuhan's lazertinib gains European approval, becoming Korea's first anticancer drug authorized in both the U.S. and Europe for NSCLC.
Huons transitions to a single-CEO structure with Song Soo-young, followed by the resignation of Yoon Sang-bae.
HK inno.N files phase 3 IND for obesity drug IN-B00009, targeting weight loss and safety in a 3-year clinical trial
Handok begins local sales of Lipidil, Abbott's hyperlipidemia drug, strengthening its chronic disease treatment portfolio.
Prag Goel joins Alembic Pharma as VP of Sales and Marketing, bringing 30 years of diverse industry experience.
HOOKIPA and Poolbeg plan all-share merger to form a Nasdaq-listed biopharma focused on cancer and unmet medical needs.
Veeda Group becomes Veeda Lifesciences, marking its growth into a full-spectrum partner in global drug development services.
Radius Pharmaceuticals partners with Pharmanovia to bring abaloparatide, an osteoporosis therapy, to the Asia Pacific region.
ANI Pharmaceuticals introduces Prucalopride Tablets, a generic Motegrity® version, following FDA approval, with a $168M U.S. market value.
Innovent and Roche collaborate on IBI3009, an inventory DLL3 ADC, with $80M upfront and $1B in milestones possible.
Karyopharm names Lori Macomber as CFO, leveraging her 20+ years in life sciences finance to drive growth and innovation.
Capricor completes BLA for deramiocel, a DMD cardiomyopathy therapy backed by Phase 2 data and Orphan Drug Designations.
NervGen enrols the final participant in the chronic cohort of its NVG-291 SCI trial, advancing to subacute screening after IRB approval.
Joseph F. McGuire, named NEXGEL's CFO, brings 30+ years of experience as Adam E. Drapczuk will remain as a consultant.
Scott Coiante was named CFO at Lexicon Pharmaceuticals, with 35 years of finance experience in life sciences, previously at Agile Therapeutics and Aprea.
HOPE Therapeutics acquires Kadima Neuropsychiatry, a leader in interventional psychiatry, to drive advanced treatments for CNS disorders.
Eton Pharmaceuticals acquires Galzin®, enhancing support for Wilson Disease patients with treatment access and global expansion.
Chime Biologics and Mabgeek achieved a significant milestone with MG-K10, an anti-IL-4Rα antibody, entering Phase III trials.
Nona Biosciences announces BeiGene's acquisition of global rights to a DualityBio-developed ADC targeting tumours.
GSK's Nucala wins approval in China as an add-on therapy for adults with uncontrolled CRSwNP, easing key symptoms.
Shilpa Medicare advances to Phase III trials for recombinant albumin, revolutionizing treatment for critical conditions.
Vetter appoints three senior leaders as managing directors, reinforcing global growth and commitment to serving patients worldwide.
Dr. Vellaian Karuppiah joins Acme and Immacule Group as COO, bringing 20+ years of expertise in manufacturing, tech transfer, and operations.
JCR and Modalis advance CNS gene therapy, validating proof of concept and entering pre-clinical studies for minimally invasive treatment
China approves first stem cell therapy for transplant complications and a new long-acting HIV drug needing only two shots a year.
NMD Pharma's NMD670 receives FDA orphan drug status to treat Charcot-Marie-Tooth disease, advancing trials for this rare neuromuscular disorder.
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EMA backs Acurx's ibezapolstat Phase 3 trials, focusing on treating CDI and reducing recurrence in global patient populations.
Perspective Therapeutics appoints Juan Graham as CFO. He brings 25 years of finance leadership from FibroGen and Johnson & Johnson.
Tempest Therapeutics’ amezalpat receives FDA Orphan Drug Designation after showing survival benefits in liver cancer trials.
Portage Biotech re-launches Cyncado Therapeutics, with CEO Peter Molloy driving the development of adenosine receptor antagonists for cancer.
ARS Pharma seeks approval for neffy in Canada and UK while advancing global licensing and clinical trials for new indications.
RAPT Therapeutics appoints Lori Lyons-Williams as board chair. Industry veteran succeeds William Rieflin, now a company consultant.
Elutia collaborates with Vizient to offer EluPro™ BioEnvelope to S3P's 993 acute care facilities, providing innovative solutions for post-surgical care.
ImmunityBio secures permanent J-code for ANKTIVA, streamlining access for bladder cancer patients and providers with broad coverage.
Dan Monahan joins Amylyx as Chief Commercial Officer, driving commercialisation and avexitide’s launch for PBH treatment.
Variant Bio joins Novo Nordisk in a $50M genomics venture to develop innovative treatments for metabolic diseases globally.
Recursion advances REC-3565 for B-cell cancers and REC-4539 for SCLC, with regulatory clearances from MHRA & FDA for Phase 1 trials.
Canyon Labs strengthens services with iuvo acquisition, focusing on end-to-end medical and pharmaceutical testing solutions.
Gain actionable insights at the Pharma Project & Portfolio Management 2025 in Goa, with expert sessions and networking.
Bio-Rad introduces 45 cm Foresight Pro Columns, enhancing downstream purification for vaccines, antibodies, and proteins.
Molex completes acquisition of Vectura, enhancing Phillips Medisize’s expertise in inhalation drug delivery and pharmaceutical R&D.
BioInvent reports a complete and partial response in the NHL trial for BI-1206 combo therapy; melanoma CR is nearing a two-year milestone.
ProBioGen enhances its protein and viral vector production with a new 1000L GMP protein line and advanced viral manufacturing facilities.
Island Pharmaceuticals starts Phase 2b trial for ISLA-101, testing its safety and effectiveness in reducing dengue virus symptoms.
Biomea Fusion shares preclinical data showing improved metabolic markers with icovamenib and semaglutide in diabetes models.
Expanded Novo Nordisk-Valo partnership leverages AI to advance 20 drug programs in cardiometabolic care globally.
Agios' PYRUKYND® gains FDA sNDA acceptance for thalassemia treatment. PDUFA decision set for September 7, 2025.
Merck's GARDASIL became the first HPV vaccine approved for males in China, targeting HPV-related cancers, warts, and precancerous lesions.
Silo Pharma receives USPTO patent approval for SPC-15, enhancing its position in PTSD therapy with intranasal drug delivery.
Tonix appointed Gary Ainsworth as VP of Market Access along with the FDA review of TNX-102 SL for fibromyalgia, a chronic pain condition.
Newron and Myung In Pharm join forces to develop and commercialise evenamide, a novel therapy for treatment-resistant schizophrenia in South Korea.
PrecisionLife appoints Bill Keating as CCO to scale Mechanostic® tests, transforming chronic disease diagnostics globally.
Catalyst resolves litigation with Teva, delaying FIRDAPSE generic launch to 2035, ensuring patient access and IP protection.
WHO's new G6PD test helps prevent complications from malaria treatments, ensuring safer care for P. vivax patients.
Evonik and ST Pharm collaborate to enhance RNA and nucleic acid therapies, speeding up treatment development.
Aspyre Lung by Biofidelity and CellCarta enhances NSCLC biomarker detection, accelerating clinical trial enrollment globally.
Jo Marshall joins Coronado as EVP of Data Services, leveraging expertise to enhance drug development and patient safety.
Zentalis secures FDA Fast Track Designation for azenosertib, targeting platinum-resistant ovarian & PROC cancers tied to Cyclin E1.
Bora Biologics partners with DotBio to accelerate DB007, a tri-specific antibody, through advanced manufacturing and development.
Seres' SER-155 data reveal improved gut barrier integrity, reduced bloodstream infections, and enhanced immune balance in allo-HSCT patients.
GSK’s Shingrix prefilled syringe application is accepted by the FDA, offering a more convenient shingles vaccination option for healthcare providers.
Rigel’s R289 granted FDA Orphan Drug Designation, boosting its development for lower-risk myelodysplastic syndromes treatment.
UCB collaborates with XtalPi, using AI-driven XtalFold™ to accelerate antibody design and biologics innovation.
Genenta and AGC Biologics expand manufacturing capacity for Temferon, supporting GBM and metastatic cancer clinical trials.
Telix expands pipeline and innovation with ImaginAb's biologics platform and radiopharmaceutical technology.
Ascendis Pharma outlines 2025 goals, introduces the new TransCon platform, and reports substantial 2024 revenues at the J.P. Morgan Conference.
Telix reclaims Scintimun to enhance diagnostic use, sales, and clinical applications for unmet medical needs.
NMPA approves Sarclisa for relapsed multiple myeloma, offering innovative treatment options in China.
PM Modi praises the completion of the Indian Genome Project, which will boost healthcare and precision medicine through genetic mapping of India’s population.
Merus and Biohaven join forces to co-develop bispecific ADCs, combining platforms to transform cancer therapy.
Caribou initiates the GALLOP Phase 1 trial for lupus, advancing CAR-T therapy programs with key 2025 data milestones.
Molecular Partners and Orano Med expand collaboration to create innovative targeted alpha radiotherapies for cancer.
AbbVie partners with Simcere Zaiming to develop SIM0500, a trispecific antibody targeting multiple myeloma.
Updates on ABBV-RGX-314 clinical programs: advancing gene therapy for wet AMD and diabetic retinopathy.
Tarsus targets ocular rosacea with TP-04, boosts XDEMVY growth, and advances global initiatives for transformative eye care.
ORIC shares 2024 achievements, including Phase 1b data for ORIC-944 and key milestones for oncology advancements.
Regeneron and Truveta announce the Truveta Genome Project, aiming to sequence 10 million genomes to transform genetic research and healthcare delivery.
Interim data from Corvus Pharmaceuticals’ Phase 1 trial of soquelitinib demonstrate safety and significant efficacy in treating moderate-to-severe atopic dermatitis.
GSK acquires IDRx for $1 billion upfront, gaining IDRX-42, a precision therapeutic targeting primary and secondary KIT mutations in GIST.
ORIC Pharmaceuticals to initiate a Phase 1b trial of ORIC-114 and SC amivantamab for first-line treatment of advanced NSCLC with EGFR exon 20 insertion mutations, starting Q1 2025.
Salarius Pharmaceuticals merges with Decoy Therapeutics to advance Decoy's peptide conjugate therapeutics pipeline, targeting respiratory infectious diseases and oncology.
Astria Therapeutics' ALPHA-ORBIT Phase 3 trial of navenibart for hereditary angioedema to evaluate Q3M and Q6M dosing, aiming for global registration and patient-centric treatment options.
Context Therapeutics announces Andy Pasternak as Chairman of its Board, bringing decades of expertise to drive innovation in T cell engagers for solid tumor treatment.
Elutia introduces EluPro™, the first FDA-cleared biomatrix to prevent infections in implantable devices.
Serina Therapeutics appoints Karen J. Wilson to its Board, enhancing leadership for transformative biotech growth.
AskBio’s Phase II gene therapy trial for Parkinson’s disease begins participant randomization, advancing AB-1005 research.
Context Therapeutics has dosed its first patient in a Phase 1 trial for CTIM-76, targeting CLDN6-positive gynecologic and testicular cancers.
Hikma teams up with Emergent for exclusive sales of KLOXXADO® 8 mg naloxone spray, expanding opioid overdose treatment options.
Acadia submits trofinetide for EMA approval as the first Rett syndrome treatment in the EU, supported by positive Phase 3 results.
Vetter's V-OVS® next closure system offers intuitive features and enhanced safety for injectable products, launching in 2027.
Sapio Sciences launches Release 24.12, adding immunogenicity automation, GMP improvements, chemistry tools, and molecular biology updates.
Enhanc3D Genomics introduces integrated 3D Multi-Omic solutions, advancing precision in drug discovery and development.
Moffitt and Cryoport partner at Speros campus, accelerating innovation in cell and gene therapies and patient care.
Keros Therapeutics halts Phase 2 TROPOS trial for PAH due to safety concerns; topline data expected by Q2 2025.
Niktimvo™, approved by the FDA, offers a new treatment option for chronic GVHD, reducing inflammation and fibrosis.
ImmunityBio shares progress with the FDA on bladder and lung cancer therapies, offering new hope for patients with limited options.
TNF Pharmaceuticals announces safety milestone for isomyosamine, advancing trials for sarcopenia, frailty, and GLP-1-induced muscle loss.
Sanabil Investments and Redesign Health team up to boost healthcare innovation in Saudi Arabia.
Piramal Pharma reduces emissions by 24,000 tCO2e yearly with biomass boiler conversion at Digwal facility.
ImmunityBio advances ANKTIVA approval in the EU and UK for bladder cancer, with potential approvals by 2026.
FDA revokes FD&C Red No. 3 for food and drugs after studies showed cancer risks in rats, though no similar effects in humans.
NORSE EIGHT trial supports Outlook Therapeutics' plan to resubmit its wet AMD therapy BLA in 2025, showcasing safety and efficacy.
Kindeva secures $129M contract to produce DuoDote® autoinjectors, aiding U.S. emergency preparedness against chemical nerve agents.
Illuccix gains European approval, revolutionizing prostate cancer imaging with superior accuracy and care.
WHO launches a $1.5B Health Emergency Appeal to address global crises, targeting urgent needs in conflict zones and severe emergencies
IDT Biologika appoints Federico Pollano as Chief Commercial Officer, leveraging his extensive experience in the biotech and CDMO industries.
Caris and Ontada team up to advance cancer research and precision medicine with integrated data solutions.
Scilex strengthens its gout treatment portfolio with ex-US rights to Gloperba®, enhancing global patient care.
Novo Nordisk’s STEP UP trial reveals 20.7% weight loss with semaglutide 7.2 mg in adults with obesity over 72 weeks.
Cormica expands into Germany with the acquisition of Zwisler Laboratorium, enhancing its European footprint in life sciences testing.
Glenmark Life Sciences is now Alivus Life Sciences as Nirma acquires 75% stake, aiming to expand in global healthcare markets.
Disc Medicine to host a call on Jan 21 at 8:00 am EST to discuss FDA updates on bitopertin for severe EPP treatment.
UK advanced therapy trials grew 7% to 187 in 2024, with Phase I trials jumping 70%, per the CGT Catapult database.
Keros Therapeutics and Takeda finalize global license agreement for elritercept, marking a significant milestone in hematologic disorder treatments.
Xilio Therapeutics announces initial Phase 2 data for vilastobart (XTX101) with atezolizumab, showcasing anti-tumor activity in MSS CRC patients.
MaaT Pharma’s PHOEBUS trial progresses with strong safety backing, advancing microbiome therapies in cancer care.
Century teams up with experts for CNTY-101 trials, advancing treatment for autoimmune diseases.
Apollo™ for CRADL® speeds up research onboarding, enhancing drug discovery through digital innovation.
ARS Pharma provides free neffy® nasal sprays to schools, enhancing allergy preparedness nationwide.
Amylyx prepares U.S. and Canadian trials for AMX0114 ALS therapy after FDA hold is lifted.
Catalyst Pharmaceuticals expands access to FIRDAPSE® in Japan, aiding LEMS patients through DyDo Pharma partnership.
Medix Biochemica acquires Germany’s CANDOR Bioscience to strengthen immunoassay solutions and support global IVD manufacturers.
Experience innovation at INTERPHEX 2025, in NYC. Join Pharma Now for expert talks, networking, and industry insights.
Cellipont Bioservices welcomes Brett Reynolds as CFO, bringing over 25 years of financial leadership experience.
AstraZeneca's C$820M investment creates 700+ jobs in Ontario, advancing life sciences and innovative medicine development.
Flagship Pioneering teams up with CUHP and MTI to drive breakthroughs in research, innovation, and biotechnology.
Veeva Systems and Zifo collaborate to integrate qcKen with Veeva LIMS, streamlining QC for biopharma with faster deployment and data workflows.
Messe München expands in India, Middle East, and Africa with Bhupinder Singh as President IMEA.
Year-two results from Roche’s EMBARK Phase III trial show Elevidys™ delivers statistically significant and clinically meaningful motor function improvements in Duchenne muscular dystrophy patients.
Pankaj R. Patel, Chairman of Zydus Lifesciences, has been awarded the Padma Bhushan for his transformative contributions to trade, industry, and healthcare in India.
The IACP Leadership Educators’ Summit 2025 in Hyderabad, supported by Pharma Now, united pharmacy educators and students to inspire innovation and excellence in the pharmaceutical sector.
FDA approves LEQEMBI® for Alzheimer’s maintenance treatment, transitioning to every four weeks.
Will Downie joins Touchlight as an adviser, driving innovation in synthetic DNA for genetic medicines.
Telix Pharmaceuticals expands U.S. operations by acquiring RLS Radiopharmacies.
Itovebi delivers significant overall survival benefits in Roche’s Phase III study for advanced breast cancer.
Study shows enobosarm helps older patients preserve muscle and improve body composition during weight loss.
Sage Therapeutics reviews strategic options after rejecting Biogen's acquisition proposal.
Merck's WELIREG sNDA for rare tumors gains FDA priority review; decision expected by May 26, 2025.
Innate Pharma launches Phase 1 trial for IPH4502, a Nectin-4-targeting ADC therapy for advanced solid tumors.
Clinigen collaborates with Tepsivo, combining expertise to enhance global Pharmacovigilance through AI-driven innovation.
The FDA accepts Alvotech and Teva’s AVT05 biosimilar for review, marking a key step in advancing treatment for inflammatory conditions.
PHARMEXCIL declares India and UAE pharmaceutical partnership, hosting the India Pavilion at Arab Health 2025 in Dubai to highlight Indian innovation and exports.
New clinical data shows cebranopadol has significantly lower intranasal abuse potential than oxycodone, reinforcing its promise in pain management.
ProductLife Group acquires Stragen Services, expanding its pharmacovigilance and clinical safety capabilities.
Lupin and Avas introduce NaMuscla® in Italy, offering the first licensed treatment for non-dystrophic myotonia.
Lupin wins FDA approval for Ipratropium Bromide Nasal Spray, a generic Atrovent® alternative for cold and allergy relief.
Argonaut and Akoya expand their partnership to produce IVD assays, advancing precision medicine with superior diagnostics.
Zentalis restructures to advance azenosertib, extending cash runway to support key trial results expected by late 2026.
Lantheus acquires Evergreen for up to $1B, strengthening radiopharmaceutical production and expanding cancer diagnostics.
Zentalis shares promising azenosertib monotherapy results in Cyclin E1+ PROC, with potential for accelerated FDA approval.
Adial Pharmaceuticals finalizes the AD04 study, confirming predictable absorption and FDA submission for AUD treatment trials.
aTyr Pharma will showcase three efzofitimod studies on pulmonary sarcoidosis at ATS 2025, sharing key trial insights.
TME Pharma teams up with Aimed Analytics to leverage AI, accelerating cancer drug research while cutting costs.
Explore cutting-edge biologics innovations, networking, and expert insights at the Biologics Workshop 2025 in Goa.
Julie Kim to succeed Christophe Weber as Takeda's CEO in June 2026, marking a new era for the pharma giant.
Cognizant earns Global Elite status in the ServiceNow Partner Program, reinforcing its leadership in AI-driven solutions.
Telix Pharmaceuticals acquires ImaginAb, adding next-generation theranostic assets, antibody technology, and a U.S. research facility to expand its oncology pipeline.
Vertex’s JOURNAVX™, a non-opioid pain reliever, gets FDA approval, offering effective, addiction-free relief for acute pain.
Cognizant And Gilead Expand Their Partnership
HOOKIPA finishes enrolling 30 participants in its Phase 1b trial for HB-500, testing safety and immunity in HIV patients.
NATCO and Breckenridge launch a generic Everolimus TFOS in the U.S., providing a cost-effective option for TSC patients.
Cognizant deepens its collaboration with Medidata, utilizing AI and expertise to streamline clinical trials and improve patient outcomes.
Experts met in Goa to explore biosimilars, gene editing, and bioprocessing innovations at Biologics Workshop 2025.
Paolo Pozzi joins Steriline as Chief Service Officer, focusing on growth, innovation, and customer satisfaction.
Roche's PATHWAY HER2 (4B5) test now identifies HER2-ultralow breast cancer patients eligible for ENHERTU® treatment, expanding its diagnostic capabilities.
Faisal G. Sukhtian is named chairman of Outlook Therapeutics’ Board, and Randy Thurman continued as lead independent director.
Lupin receives FDA approval for its generic version of Symtuza®, securing first-to-file exclusivity in the U.S. market.
Aplagon secures €7M in funding to advance its APAC therapy for thrombo-inflammatory diseases into Phase 2a clinical trials.
Sandoz announces Francisco Ballester’s retirement, with Peter Stenico succeeding him as President Region International, effective March 1, 2025.
Ocugen’s OCU400 earns EMA ATMP classification, advancing its Phase 3 trial for broad retinitis pigmentosa treatment.
PacBio appoints David Ruggiero as Global Head of Sales & Service to accelerate growth and customer engagement worldwide.
Entrada Therapeutics to begin a Phase 1/2 trial of ENTR-601-44 for Duchenne after securing MHRA authorization.
FDA supports Spur Therapeutics' Phase 3 trial of FLT201, a gene therapy for Gaucher disease, with potential for fast approval.
Serina Therapeutics closes $5M funding from JuvVentures, moving SER-252 into human trials for Parkinson’s in 2025.
uniQure's AMT-191 gene therapy for Fabry disease moves forward as the Phase I/IIa trial enters its second cohort.
Sernova seeks FDA approval to trial its Cell Pouch thyroid therapy, a potential long-term solution for hypothyroidism.
Cosette Pharmaceuticals names Brad Leonard as VP to drive generics commercial strategy and growth.
TriLink teams up with Avantor to enhance access to its nucleic acid technologies across EMEA, improving lead times.
Roche’s Susvimo gains FDA approval, providing a breakthrough treatment for diabetic macular edema with fewer injections.
Astellas Pharma is restructuring its management team, introducing new leadership roles to enhance R&D, commercialization, and compliance.
Outlook Therapeutics presents NORSE EIGHT trial data at the Virtual Investor “What This Means” segment and plans to resubmit ONS-5010 for FDA approval.
Jabil strengthens its Pharmaceutical Solutions portfolio with Pii acquisition, boosting aseptic filling and drug production capacity.
Bhavin Mehta joins Pharmexcil as Vice-Chairman, aiming to expand India’s pharmaceutical exports and MSME growth.
Astellas submits an NDA in Japan for ACP, aiming to bring the first GA treatment to patients facing progressive vision loss.
The Union Budget 2025-26 enhances India's healthcare, pharma, and medical R&D with key investments and reforms.
Eleva secures GMP production with 3PBIOVIAN, advancing Factor H (CPV-104) and expanding its moss-based expression system.
Vaxcyte's VAX-31 vaccine study progresses to Phase 2, bringing hope for preventing pneumococcal disease in infants! Data expected in 2026.
Aprea strengthens IP for ATR & WEE1 cancer therapies, securing patents till 2044, plus added exclusivity.
Amgen & Accumulus launched the first digital CMC dossier, revolutionizing global drug approvals with real-time access.
Myriad & Lumea integrate Prolaris and MyRisk tests into BxLink, cutting errors & delivering results in under 10 days.
Codexis welcomes Arthur Levin, PhD, a pioneer in RNA therapeutics, to its Strategic Advisory Board to support the expansion of its ECO Synthesis™ platform for enzymatic oligonucleotide manufacturing.
Lipella’s LP-310 gains FDA approval for expanded access, providing relief for oral lichen planus patients in need.
Tonix’s TNX-1500 demonstrates strong safety and efficacy in Phase 1, paving the way for Phase 2 kidney transplant trials.
Healthcare and pharma leaders applaud Union Budget 2025-2026; the pharma chiefs also appreciate the step towards healthcare, startups, and medical tourism.
FDA extends PDUFA date for Eton Pharmaceuticals’ ET-400 NDA, with approval expected by May 28, 2025.
BioMed X and Merck complete an oncology project on ecDNA, with findings acquired for potential cancer therapy development.
Senseonics files for CE Mark approval of Eversense 365, the only one-year continuous glucose monitor, aiming to bring long-term CGM benefits to European diabetes patients.
Alumis and ACELYRIN will merge, creating a $737M-backed immunology powerhouse with funding secured through 2027.
Pharma Now partners with PharmaTech Expo 2025, fostering pharma innovation in Bengaluru with 156 exhibitors and 4,000 attendees.
Santhera Pharmaceuticals appoints Catherine Isted as CFO, leveraging her expertise in biotech finance and corporate strategy.
Preliminary HLA data from the FLAMINGO-01 trial strengthens the outlook for GLSI-100 in breast cancer immunotherapy.
Dr. Joshua Bleharski joins IDEAYA as CFO, bringing years of biopharma finance expertise to fuel company growth.
GTx-104 reduced hypotension and improved outcomes in aSAH patients compared to oral nimodipine in Phase 3 trial.
Dr. Douglas Faller joins IMUNON as CMO to advance IMNN-001 for advanced ovarian cancer, with a Phase 3 trial set for early 2025.
Clearside unveils ODYSSEY Phase 2b results, guiding its Phase 3 trials for wet AMD treatment.
Achieve Life Sciences advances its NDA plans as the DSMC confirms strong safety data in its ORCA-OL smoking cessation trial.
Tempest’s amezalpat earns FDA Fast Track for liver cancer, showing strong survival benefits in trials.
ImmixBio’s NXC-201 earns FDA RMAT designation, accelerating development for relapsed AL amyloidosis therapy.
Dan Kirby joins Iovance as CCO, bringing decades of expertise to expand TIL therapy and Proleukin sales globally.
Medera’s CTScreen™ installed at UMC Utrecht, advancing cardiac disease modelling and drug screening with human-based tech.
Ashvattha’s subQ MGB shows promising Phase 2 data, cutting treatment burden in wet AMD & DME with strong safety results.
Palisade Bio’s PALI-2108 reduces UC symptoms in preclinical studies, showing strong potential for clinical use.
Oragenics and BRAINBox Solutions collaborate to create a breakthrough intranasal therapy and diagnostic platform for concussions.
Novartis is acquiring Anthos Therapeutics, strengthening its cardiovascular pipeline with abelacimab, a next-generation anticoagulant for stroke prevention.
PathAI and Rede D’Or collaborate to introduce AI-driven digital pathology, enhancing diagnostics and research in Brazil.
60 Degrees Pharma gains FDA approval to import KODATEF, ensuring continued malaria prophylaxis amid rising ARAKODA demand.
Bolt and Toray's collaboration targets Caprin-1, aiming to improve cancer treatments with innovative therapies.
Kiora Pharmaceuticals' KIO-104 approved for Phase 2 trial, aiming to treat retinal macular edema with fewer side effects.
Voyager shifts SOD1 ALS gene therapy focus, delaying IND filing to explore new payloads; cash runway to mid-2027.
FDA accepts Regeneron’s BLA resubmission for linvoseltamab in relapsed/refractory multiple myeloma; decision due July 2025.
Silo Pharma announces promising preclinical results for SP-26, a ketamine implant for chronic pain and fibromyalgia; final data due March.
Charles River and Deciphex deepen partnership to enhance AI tools, streamline toxicologic pathology workflows, and boost efficiency.
Experts at the 8th Annual Pharma Project & Portfolio Management 2025 explore AI, strategy, and industry innovation.
AbbVie and Xilio collaborate to develop novel tumor-activated immunotherapies, aiming for safer, more effective cancer treatments.
Genentech’s Evrysdi tablet gains FDA approval, providing a flexible and non-invasive treatment option for SMA patients.
MMS expands its expertise with the acquisition of Exploristics, enhancing biostatistics, data science, and clinical trial design.
HEJJE adds Dr. Prabhavathi R., a leading pediatrician specializing in neurodevelopmental disorders, to its expert healthcare team.
Synexa Life Sciences achieves the highest My Green Lab Certification, driving sustainability in lab operations and clinical research.
Robin Kenselaar is Orchard's new CCO, set to drive global strategy as the company advances gene therapies.
UK approves Telix’s Illuccix, a next-gen PET imaging agent that enhances prostate cancer detection and management.
NYBCe researchers identify immune pathways in Sickle Cell Disease, opening doors to innovative treatment approaches.
Theratechnologies has resumed EGRIFTA SV® distribution in the U.S. after FDA clearance, ensuring continued patient access.
Dr. Navin Saxena awarded Russia’s 'Order of Friendship' and 'Memorial Medal' for his contributions to science and Indo-Russian relations.
Lacutamab earns FDA Breakthrough Therapy status for relapsed Sézary syndrome, advancing treatment for rare T-cell lymphoma.
Dupixent gains FDA Priority Review for treating bullous pemphigoid, offering hope for patients with this severe skin condition.
Mukhtar Ahmed joins BC Platforms as CEO, bringing extensive expertise to advance real-world data innovation in life sciences.
AlgoTx’s ATX01 Phase 2 trial for neuropathic pain reports encouraging efficacy signals despite high placebo response.
Zymeworks appoints Oleg Nodelman, Founder of EcoR1 Capital, to its Board of Directors, reinforcing strategic leadership in biotech innovation.
Merck’s WELIREG receives EU approval for treating advanced RCC and VHL disease, bringing new hope to patients.
Biogen teams up with Stoke to develop zorevunersen, a potential first-in-class treatment for Dravet syndrome.
Cabaletta Bio reveals new data on rese-cel, highlighting its potential to treat autoimmune diseases without steroids.
Dr. Vivek Reddy to lead Orchestra BioMed’s BACKBEAT study, advancing AVIM therapy for patients with uncontrolled hypertension.
Opus Genetics doses first pediatric patient in its OPGx-LCA5 trial for Leber congenital amaurosis, with initial data expected by Q3 2025.
Supernus' SPN-820 misses primary and secondary endpoints in Phase 2b trial for treatment-resistant depression but remains safe.
Lexicon's study confirms sotagliflozin reduces MACE, heart attack, and stroke risk in T2D and CKD patients per SCORED trial.
Tiziana doses four more na-SPMS patients in expanded access for foralumab; 10 early patients show stability or improvement.
Queensland advances biotech, AI-driven healthcare, and clinical research partnerships with India at BioAsia 2025.
Acurx Pharmaceuticals earns a Japanese patent for DNA Polymerase IIIC inhibitors, advancing its innovative antibiotic research.
Amneal launches mesalamine tablets for ulcerative colitis and secures FDA approval for generic lenalidomide in the U.S.
ImmunityBio’s FDA-approved EAP offers a new BCG source to tackle bladder cancer drug shortages, effective in EU trials.
Adial wins a U.S. patent for genetic-based addiction treatment, enabling personalised therapy for alcohol and opioid disorders.
Milestone gains a U.S. patent for CARDAMYST’s repeat dose regimen, extending IP protection and awaiting FDA approval.
Chugai Pharmaceutical’s Tecentriq® (atezolizumab) gains Japan’s MHLW approval as the first immune checkpoint inhibitor for treating unresectable alveolar soft part sarcoma.
Terns Pharmaceuticals appoints Robert Azelby to its board, strengthening leadership in oncology and obesity research.
Elixirgen’s gene therapy EXG-34217 gains FDA Orphan Drug Designation for Telomere Biology Disorders treatment.
Roche’s SBX technology sets a new standard in high-speed, high-accuracy sequencing, transforming genomics and disease research.
Neurona advances NRTX-1001 to Phase 3, aiming to revolutionize treatment for drug-resistant epilepsy with cell therapy.
Inventiva and Hepalys launched a Phase 1 trial in Japan to assess the lanifibranor’s safety and support future MASH treatments.
Discover AI-driven drug discovery, compliance trends, and sustainability in Pharma Now’s Feb-Mar 2025 edition.
Dr. Gregory George joins Mesoblast’s Board, bringing expertise in medical innovation and commercial expansion.
Sandoz introduces Pyzchiva®, a biosimilar to Stelara®, expanding treatment access for chronic inflammatory diseases in the US.
Phase 2 trial data reveal Lusvertikimab’s efficacy in ulcerative colitis, achieving key remission and healing milestones.
Cellectis presents a breakthrough CAR T-cell strategy using IL-2 to boost solid tumor treatment at AACR-IO 2025.
Takeda’s new 2 mL pre-filled pen for TAKHZYRO® offers greater flexibility for hereditary angioedema patients in the EU.
NGM Bio’s Phase 2 trial of NGM120 aims to provide a breakthrough therapy for hyperemesis gravidarum by blocking GDF15.
Atea Pharmaceuticals appoints Arthur Kirsch to its Board, enhancing financial strategy for antiviral drug development.
BioMarin adds Timothy Walbert to its Board, leveraging his biotech leadership to advance innovative rare disease treatments.
ElevateBio’s LETI-101 achieves over 80% reduction of mutant huntingtin protein, showing promise for HD treatment.
PDS Biotech’s Versamune® HPV clears HPV16-positive tumor DNA, showing promise for HPV-related cancer treatment.
Calidi Biotherapeutics launches a new trial for CLD-101, aiming to improve treatment for high-grade glioma patients.
Kevin Springman joins Avadel Pharmaceuticals as VP of Sales to expand LUMRYZ’s reach in the sleep medicine market.
Russell Bradley joins CNSide Diagnostics as President to drive growth and market introduction for CNS cancer diagnostics.
Regeneron's DB-OTO trial shows improved hearing in children with genetic deafness, with near-normal results in some cases.
Inhibikase appoints top pharma executives, strengthening leadership in PAH research, development, and corporate strategy.
Bavarian Nordic and Biological E. partner to boost chikungunya vaccine access in LMICs through manufacturing expansion.
Oragenics’ Dr. James Kelly joins The Leigh Steinberg Foundation’s Medical Board to drive concussion research.
Andrew Gengos joins Terns Pharmaceuticals as CFO, bringing 25 years of biotech finance and strategy expertise.
ORIC Pharmaceuticals accelerates clinical plans for ORIC-944 and ORIC-114, extending its cash runway into 2027.
Celularity secures FDA TRG recommendations for Natalin and Acelagraft™, advancing its regenerative medicine portfolio.
Austria approves VAZKEPA® reimbursement, expanding access to cardiovascular care and strengthening Amarin’s European presence.
CAN-2409 trial shows long-term survival benefits for pancreatic cancer patients, offering new hope for treatment.
UZEDY’s sNDA accepted by FDA, marking a step toward long-acting treatment options for bipolar I disorder.
Telix’s TLX250-CDx for kidney cancer imaging gets FDA Priority Review, with a PDUFA date set for August 27, 2025.
Adial gains FDA support for AD04’s bridging strategy, advancing toward Phase 3 trials in 2025 for addiction therapy.
Allogene and Foresight partner to develop an MRD assay as a companion diagnostic for LBCL patients in the ALPHA3 trial.
Actuate enrolls 56 patients in its Phase 2 trial evaluating elraglusib, FOLFIRINOX, and losartan for metastatic pancreatic cancer.
LIXTE adds Lurie Cancer Center as a second site in its trial testing LB-100 and Dostarlimab for ovarian clear cell cancer.
Elixirgen reports the first-ever sustained telomere elongation in TBD patients using EXG-34217, with no safety concerns.
Lucid-MS, a neuroprotective MS drug by Quantum BioPharma, completes Phase 1 trial with no safety concerns.
Silo Pharma secures a new patent for SPC-15, an intranasal PTSD treatment, strengthening its intellectual property portfolio.
Renovaro and BioSymetrics merge to harness AI for biomarker discovery, precision medicine, and faster drug development.
Derm-Biome’s DB-007-5 surpasses top AD drugs in reducing itch and inflammation, showing promise for first-line treatment.
Rakovina and Variational AI strengthen their partnership to accelerate AI-powered cancer drug discovery.
IMUNON’s IMNN-101 vaccine demonstrates safety, strong immune response, and potential for future pandemics.
Humacyte launches Symvess, a bioengineered vessel designed to revolutionize emergency vascular repair and save limbs.
PDS Biotech’s immunotherapy Versamune® HPV shows promising clinical results in HPV-related cancers, per JAMA Oncology study.
Pharma leaders unite in Jordan for ARAB PHARMA MANUFACTURERS’ EXPO 2025, focusing on innovation and industry growth.
Hikma launches the first generic Mercaptopurine Oral Suspension in the US, gaining FDA approval and CGT exclusivity.
Nxera Pharma assigns APAC rights for cenerimod to Viatris, securing $10M and future milestone payments.
Cyclacel Pharmaceuticals names Datuk Dr. Doris Wong Sing Ee as CEO following a major ownership and leadership transition.
Myriad Genetics partners with Gabbi to integrate genetic testing with telehealth breast cancer risk assessment and specialist care.
Alumis unveils new data on A-005, a CNS-penetrant TYK2 inhibitor, with plans for a Phase 2 trial in multiple sclerosis.
Ocugen’s OCU410ST gains FDA backing for a Phase 2/3 trial, offering new hope for Stargardt disease patients.
Medicus Pharma begins a UAE clinical study for its non-invasive BCC treatment, strengthening its global development program.
It will bring together Europe’s top pharmaceutical outsourcing decision-makers, shining a spotlight on this rapidly growing industry.
NYBCe and Human Life CORD partner to advance MSC manufacturing, strengthening regenerative medicine supply worldwide.
AstraZeneca and Daiichi Sankyo’s Enhertu receives CHMP recommendation for EU approval in HR-positive, HER2-low or HER2-ultralow metastatic breast cancer.
Novartis will showcase remibrutinib and Cosentyx® data at AAAAI/WAO and AAD 2025, supporting CSU regulatory filings.
Strand Life Sciences introduces the StrandOmics Portal to enhance rare disease diagnosis with faster genetic insights.
Valneva’s IXCHIQ® receives CHMP support for adolescent use, with EU approval expected in 60 days, boosting access.
Vincerx Pharma cancels reverse merger and explores strategic options, including M&A, asset sales, or winding down.
AbbVie and Gubra sign a licensing deal for GUB014295, a long-acting amylin analogue in Phase 1 trials for obesity.
Roche’s OUtMATCH study confirms Xolair’s effectiveness over OIT for food allergies, with fewer adverse events.
AstraZeneca’s Imfinzi gains EU backing for NSCLC, reducing recurrence risk by 32% in the AEGEAN trial.
Oryzon sets Phase III trial endpoints for vafidemstat in BPD, aligning with FDA standards and planning 2025 regulatory submission.
Australias TGA rejects lecanemab for early Alzheimers, disagreeing on safety for ApoE4 heterozygotes despite Eisais proposals
ACP-711 proves safe in Phase 1 study, prompting plans for further trials in elderly volunteers and higher doses.
Protagonist & Takeda’s rusfertide meets all endpoints in Phase 3 study, offering hope for polycythemia vera patients.
Seres Therapeutics receives FDA feedback on SER-155, planning next study to support allo-HSCT patients.
Pliant Therapeutics halts BEACON-IPF trial due to safety issues but sees early efficacy signs in pulmonary fibrosis treatment.
Genentech's TNKase gets FDA approval for acute ischemic stroke, providing a faster alternative to standard treatment.
Voyager's VY7523 anti-tau antibody demonstrates strong safety and tolerability in early trials, advancing to the next phase in Alzheimer's treatment research.
Zentalis will showcase azenosertib data at SGO 2025, highlighting clinical updates and biomarker insights in ovarian cancer.
Acurx's ibezapolstat shows reduced gut microbiome disruption in CDI treatment, surpassing VAN and MET in a study.
Ocugen’s gene therapies for vision loss receive EMA backing, showing promise in treating GA and Stargardt disease.
Amneal’s denosumab biosimilars move forward with FDA review, aiming to compete in the $5B osteoporosis drug market.
ANI Pharmaceuticals secures FDA approval for a prefilled Cortrophin® Gel syringe, enhancing convenience for patients.
Adverum launches ARTEMIS Phase 3 trial for Ixo-vec, a gene therapy designed to reduce injections for wet AMD patients.
Baxter introduces Voalte Linq, a voice-activated wearable that enhances hospital communication and workflow efficiency.
FDA accepts Roche’s sBLA for Gazyva in lupus nephritis, based on positive Phase III REGENCY study results.
Nelson Labs introduces Rapid Sterility Testing at three sites, cutting testing time while ensuring regulatory compliance.
Evotec receives $20M from Bristol Myers Squibb as their neuroscience collaboration reaches a key milestone.
J&J names Darren Snellgrove VP of Investor Relations as Jessica Moore becomes CFO of Innovative Medicine.
New research confirms NXP900 boosts osimertinib’s effect in EGFR-mutated NSCLC, reducing resistance and tumour growth.
Tiziana submits IND for Phase 2 ALS trial of intranasal foralumab, aiming to improve treatment for neurodegenerative diseases.
Enzene’s Pune sites receive EU GMP certification, supporting commercial biologics production with advanced manufacturing tech.
Syner-G & Sequoia appoint Chris Erickson as COO, leveraging his 25+ years of experience to drive operational growth.
Aenova upgrades Bad Aibling site with €20M investment, enhancing blister and effervescent packaging capabilities.
Jazz acquires Chimerix for $935M, adding glioma treatment dordaviprone to its rare oncology pipeline.
Tenax increases TNX-103 trial enrollment and prepares for global Phase 3 study, aiming to advance PH-HFpEF treatment.
Certara appoints Adrian McKemey to lead drug development solutions, enhancing biosimulation and R&D strategy.
Vaxart's oral norovirus vaccine shows strong immune responses in older adults, published in Science Translational Medicine.
Circio's circVec platform shows 70x RNA durability vs. mRNA, opening new possibilities for gene and cell therapies.
Lisata and GATC Health deepen partnership to develop a non-opioid treatment for opioid use disorder, targeting Phase 1 trials in early 2026.
Oryzon publishes a PMS study, paving the way for vafidemstat trials in precision psychiatry and rare CNS disorders.
Acadia’s DAFFODIL™ study affirms DAYBUE’s safety in Rett syndrome patients aged 2–4, reinforcing FDA-approved use.
Parexel appoints Jeff Bernstein, Partner at Goldman Sachs Asset Management, to its Board of Directors, bringing extensive healthcare investment and leadership experience.
aTyr Pharma’s Phase 3 EFZO-FIT™ study on efzofitimod advances smoothly after a positive safety assessment.
Ourvita expands in Asia with Braveiy acquisition, enhancing global manufacturing and innovation in health and wellness.
Sun Pharma expands oncology portfolio with Checkpoint acquisition, bringing FDA-approved UNLOXCYT to global markets.
OMLYCLO® becomes the first FDA-approved interchangeable biosimilar to XOLAIR®, expanding treatment access for allergy patients.
Novo Nordisk’s CagriSema shows major weight loss benefits for obesity and diabetes, with FDA filing expected in 2026.
VIVUS’ QSYMIA® gets UAE approval, expanding treatment options for obesity in adults and children aged 12 and older.
Dr. Mark Frohlich joins Rigel’s Board, adding expertise in oncology and immunotherapy to its leadership team.
Pittcon 2025 in Boston featured groundbreaking lab innovations, expert insights, and global scientific collaboration.
4D Molecular Therapeutics advances to Phase 3 with its 4D-150 gene therapy for wet AMD, aiming to reduce treatment burden and preserve vision.
Biodexa gains FDA guidance for its Phase 3 eRapa trial in FAP, setting the stage for patient enrollment next quarter.
Tevogen Bio patents an AI-powered T-cell vaccine designed to target entire viral genomes and enhance immune response.
CervoMed’s neflamapimod shows promising results in the 16-week extension phase of Phase 2b trial for dementia with Lewy bodies.
LIXTE announces findings on LB-100 activation, identifying a biomarker that may predict patient response to treatment.
Tonix receives MCDC funding for TNX-801, mpox and smallpox vaccine, supporting market analysis and commercialization.
The 9th Biologics Festival & 15th Vaccine World Summit 2025 drive innovation in India's biopharma industry.
Phase 3 results show vepdegestrant improves progression-free survival in ER+/HER2- metastatic breast cancer patients.
Olivia Brown joins Ipsen to drive global neurotoxins strategy, overseeing therapeutic and aesthetic growth initiatives.
Roche and Zealand Pharma collaborate to develop petrelintide, aiming to transform obesity care with innovative therapies.
Madrigal welcomes biotech leader Jackie Fouse to its board as the company expands MASH treatment efforts.
Kane Biotech marks a three-year deal with Best Buy Medical to expand revyve™ Antimicrobial Wound Gel in Canada.
Merck launches a $1B Durham vaccine plant, integrating AI, 3D printing, and digital twin tech for efficiency.
Cognizant and Boehringer launch a unified Veeva-powered platform, enhancing drug development and regulatory workflows.
aTyr Pharma’s efzofitimod study reveals its role in reducing lung inflammation and fibrosis via NRP2 targeting.
Portage Biotech resumes patient enrollment in the final dose escalation stage of its PORT-6 Phase 1b trial after a funding delay.
FDA expands ILUVIEN’s label to include chronic non-infectious uveitis, improving treatment options for patients.
Gradalis' study in Scientific Reports highlights exome sequencing to enhance cancer immunotherapy targeting.
Dyne’s DYNE-251 demonstrates sustained improvement in Duchenne patients, advancing toward potential FDA approval in 2026.
Roche unveils long-term data at MDA 2025: Evrysdi shows sustained motor function stabilization in SMA, while Elevidys demonstrates promising results in DMD treatment.
TRYVIO is now fully released from REMS, expanding access to patients with difficult-to-control hypertension.
ASIA LABEX 2025 unites experts, exhibitors, and innovators to showcase the latest lab advancements in Chandigarh.
Argent BioPharma reports positive Phase IIb results for CimetrA®, highlighting its safety, faster recovery, and anti-inflammatory potential.
AstraZeneca's acquisition of EsoBiotec aims to transform cell therapy, making treatments faster and more accessible.
BridgeBio Pharma welcomes Thomas Trimarchi as President & CFO while Brian Stephenson transitions to a consulting role.
Eneboparatide meets key endpoints in a Phase III trial, showing promise for chronic hypoparathyroidism treatment.
Pliant’s PLN-101095, combined with pembrolizumab, shows anti-tumor activity in ICI-refractory cancers in Phase 1 trial.
Telix’s Illuccix® secures ANVISA approval, bringing advanced PSMA-PET imaging to prostate cancer patients in Brazil.
AstraZeneca’s Imfinzi secures EU approval, offering a new immunotherapy option for limited-stage small cell lung cancer.
Perspective Therapeutics doses first patient in a new cohort studying [212Pb]VMT01 with nivolumab for melanoma treatment.
Greenwich LifeSciences’ FLAMINGO-01 trial confirms GLSI-100’s strong safety profile, with no serious adverse events.
Capricor’s HOPE-2 trial data shows deramiocel preserves muscle function, slowing Duchenne muscular dystrophy progression.
Genmab’s Rina-S achieves a 55.6% response rate in ovarian cancer, with Phase 3 trials underway for further evaluation.
AstraZeneca licenses ALT-B4 from Alteogen to develop subcutaneous cancer treatments, improving patient convenience.
SIGA adds General Jack Keane to its board, enhancing biodefense strategy with his national security expertise.
Whitehawk Therapeutics unveils its new name and vision, accelerating next-gen ADCs for cancer treatment.
Chugai introduces LUNSUMIO, a bispecific antibody, as a new treatment for relapsed follicular lymphoma in Japan.
FDA accepts BLA for AVT03, a proposed biosimilar to Prolia® and Xgeva®, developed by Alvotech and Dr. Reddy’s.
Allogenica receives €2.5M to scale its universal CAR-T therapy, offering a cost-effective solution for blood cancer patients.
ANI Pharmaceuticals introduces Nitazoxanide Tablets, offering a cost-effective alternative for patients nationwide.
Auron Therapeutics names Glenn Goddard as CFO, strengthening financial strategy as it advances groundbreaking therapies.
Todd Baumgartner joins Applied Therapeutics as Chief Regulatory Officer to lead global regulatory strategy for rare disease therapies.
Join the London Biotechnology Show 2025 at ExCeL London for cutting-edge insights, networking, and industry advancements.
Recognizing top pharma quality teams for innovation, reliability, and industry leadership. Nominate today!
Join industry leaders in Mumbai for Pharma GMP & Quality 2025, focusing on compliance, AI, and manufacturing excellence.
Merck unveils breakthrough research on PAH & cholesterol management at ACC.25, shaping the future of heart health.
Join top EHS leaders at the 2nd EHS for Biopharma East Summit 2025 to explore safety, sustainability, and compliance trends.
Sanofi strengthens its immunology pipeline by acquiring DR-0201, a novel B-cell depletion therapy for autoimmune diseases.
Alvotech expands R&D with Xbrane’s acquisition, strengthening biosimilar development and establishing a Swedish presence.
Infinitopes welcomes biotech leaders Dan Menichella & Jo Brewer to its board as it moves its cancer vaccine ITOP1 into clinical trials.
Novartis' gene therapy OAV101 IT improves motor function in SMA patients, marking a major step forward in treatment.
Dr. Igor Matushansky joins Immuneering to lead clinical trials for cutting-edge cancer therapies, including IMM-1-104.
Plus Therapeutics secures FDA conditional acceptance for REYOBIQ™, its lead radiotherapeutic for CNS cancers, boosting brand recognition.
CARBIOS names Isabelle Parize as Chairwoman and Vincent Kamel as CEO, following Philippe Pouletty’s resignation.
FDA approves Telix’s Gozellix®, improving PSMA-PET imaging access for prostate cancer patients across the U.S.
Harbour BioMed and AstraZeneca team up on next-gen antibody therapies, with a $105M investment and $4.7B in milestone payments.
CStone applies for EMA approval of sugemalimab in stage III NSCLC, backed by strong GEMSTONE-301 Phase III trial results.
Everest’s EVM14, an mRNA cancer vaccine for NSCLC and HNSCC, gets FDA IND clearance, marking a key milestone.
Junshi Biosciences’ Toripalimab-Bevacizumab Combo Gains NMPA Approval for First-Line Advanced Liver Cancer Treatment
Newronika’s AlphaDBS receives CE Mark, bringing adaptive deep brain stimulation to Parkinson’s patients in Europe.
DBV's Viaskin peanut patch for 4–7-year-olds advances toward FDA approval with VITESSE data, accelerating its launch.
Novo Nordisk secures global rights (ex. China) for UBT251, a next-gen obesity & diabetes drug, in a $2B deal with TUL.
Elicio Therapeutics names Dr. Preetam Shah as CFO, strengthening its leadership in cancer immunotherapy innovation.
PharmAla partners with a U.S. logistics firm to enhance MDMA clinical trial distribution and mitigate import risks.
The FDA is reviewing tolebrutinib to slow MS-related disability, with a decision expected by September 2025.
Tempero Bio starts a Phase 2 trial for TMP-301, an mGluR5 NAM for alcohol use disorder, under a deal with Nxera.
New data from Onconetix’s Proclarix® confirms high accuracy in prostate cancer detection, reducing false positives.
Alumis teams up with Kaken to bring ESK-001, a next-gen TYK2 inhibitor, to Japanese patients with immune disorders.
AstraZeneca’s Tagrisso shows strong results at ELCC 2025, extending survival and quality of life for lung cancer patients.
Hikma strengthens its US portfolio with Cisatracurium Besylate Injection, supporting anesthesia and critical care.
TFS HealthScience appoints Miriam Martin as VP of Business Development, strengthening strategic growth and clinical innovation.
Merck secures global rights to HRS-5346, an investigational Lp(a) inhibitor, in a deal worth up to $1.97 billion.
Charles River and Valo Health’s AI-powered Logica® identifies a potential lupus treatment, accelerating drug discovery.
Elutia’s antibiotic-eluting bioenvelope eradicates bacteria, showing promise in preventing CIED infections.
David Banko joins Tevogen Bio as Global Head of Government Affairs, driving patient access and commercialization strategies.
Sanofi’s mRNA chlamydia vaccine moves forward with FDA fast track, aiming to combat rising global infection rates.
Jane Healy joins Photocure as GM EMEA, bringing decades of expertise to drive growth in uro-oncology across Europe.
Alvotech, Kashiv, and Advanz Pharma announce MHRA acceptance of AVT23, a biosimilar to Xolair® for asthma and nasal polyps.
Shane Olwill joins Asgard Therapeutics as CDO to lead the development of AT-108, a breakthrough cancer immunotherapy.
Avalo Therapeutics welcomes Michael Heffernan as Chairman to drive growth and pipeline expansion in immune-mediated diseases.
Intellia’s NTLA-2001 earns FDA RMAT designation, accelerating its development for transthyretin amyloidosis with cardiomyopathy.
Join biopharma experts in San Francisco for key insights on biotech, biomanufacturing, and future innovations.
Pittcon 2027 brings global scientists back to Pittsburgh, marking 60 years since its last event in the city.
Ajay Royan rejoins Invivyd’s Board to support breakthrough monoclonal antibody treatments for high-risk patients.
Chugai’s Evrysdi tablet offers SMA patients a more convenient treatment option with easier storage and administration.
Alvotech welcomes Dr. Balaji Prasad as Chief Strategy Officer to advance biosimilar innovation and global market expansion.
BridgeBio receives Japanese approval for Beyonttra (acoramidis) to treat ATTR-CM, with Alexion leading commercialization and a $30M milestone payment.
LIXTE Biotechnology updates on LB-100 trials for ovarian and colorectal cancer, progressing with GSK and Roche collaborations.
CPHI Americas 2025 gathers pharma leaders in Philadelphia for three days of networking, innovation, and collaboration.
Merck’s subcutaneous pembrolizumab meets key endpoints in Phase 3 trial, showing promise for lung cancer treatment.
PacBio names Jim Gibson as CFO, tapping into his leadership experience from Tesla, Apple, and Netflix to fuel growth.
Regeneron and Sanofi’s Dupixent receives approval in Japan for COPD, offering new hope for patients with uncontrolled disease.
IASO Bio secures NDA approval in Macau for Equecabtagene Autoleucel, a breakthrough for relapsed multiple myeloma.
Chugai and IFReC uncover FOXP3’s regulatory network, opening doors to innovative autoimmune disease treatments.
Elutia teams up with Advantus to offer EluPro™, an FDA-cleared antibiotic-eluting BioEnvelope, through GPO networks.
Genmab’s TIVDAK gets Japan’s first ADC approval for advanced cervical cancer, cutting death risk by 30% in trials.
FDA flags manufacturing and impurity issues in CARDAMYST review; Milestone to work on resubmission for approval.
Langhua Pharmaceutical passes its fourth FDA inspection, boosting its global CDMO services for small-molecule drug development.
CDMO Live 2025 unites pharma leaders in Rotterdam to discuss outsourcing, innovation, and strategic partnerships.
Novartis promotes Karen Hale to Chief Legal & Compliance Officer as Klaus Moosmayer steps down in April 2025.
AstraZeneca’s Calquence receives CHMP recommendation, showing a 27% risk reduction in MCL progression or death.
Valneva applies for UK approval to extend IXCHIQ® use to adolescents, following EMA’s positive opinion.
AAVantgarde and TIGEM's study in Science Advances highlights a novel AAV-based gene therapy for Stargardt’s disease.
IDEAYA’s darovasertib gets FDA Breakthrough Therapy status for neoadjuvant uveal melanoma treatment, advancing to Phase 3.
Kenan Thompson shares his GERD journey with Phathom to help others find relief and spark conversations on treatment.
Merck’s WINREVAIR™ delivers a 76% risk reduction in PAH mortality & hospitalization in a groundbreaking clinical trial.
TransCon CNP, a weekly treatment for achondroplasia, shows promise in growth, muscle function, and leg straightening.
Nxera Pharma appoints Kiyoshi Kaneko as CCO and promotes Mariko Nakafuji to CLO to support global expansion.
TEV-'749 receives strong patient and provider satisfaction in the SOLARIS trial, presented at SIRS 2025.
LIXTE and NKI launch a pre-clinical study to explore LB-100’s ability to eliminate early cancer-linked cells.
TIVDAK earns EU approval, becoming the first ADC for recurrent or metastatic cervical cancer, improving survival rates.
Telix initiates the ZOLAR trial, exploring TLX300-CDx as a theranostic solution for metastatic soft tissue sarcoma.
TONIX ONE™ integrates telehealth, e-prescriptions, and symptom tracking to simplify migraine management.
The EU grants approval for Valneva’s IXCHIQ® vaccine in adolescents, expanding protection against chikungunya.
Amneal and Shilpa debut BORUZU™, a ready-to-use bortezomib injection for multiple myeloma and lymphoma, simplifying prep.
Apellis’ EMPAVELI® for rare kidney diseases gets FDA Priority Review; intense Phase 3 results support approval bid.
Inventiva enrolls 1,419 patients in Phase 3 trial for lanifibranor, a potential MASH treatment; results expected in H2 2026.
Join experts at Pharma Sterile & Injectables 2025 to explore innovations, regulations, and best practices in manufacturing.
Rilzabrutinib receives FDA orphan drug status for wAIHA & IgG4-RD, marking progress in rare disease treatment.
Novo Nordisk restructures its executive team as Camilla Sylvest steps down, appointing new leaders in key strategic roles.
Roche’s Phase III MUSETTE trial confirms OCREVUS 600 mg as optimal for MS, showing record-low relapse rates.
Algorae welcomes Vishal Shah as CCO, leveraging his 20+ years of pharma leadership to fuel growth and innovation.
Anne Whitaker joins Telix as Non-Executive Director, bringing global pharma and Nasdaq governance expertise.
Globus Medical completes Nevro acquisition, unlocking a $2.5B chronic pain and neuromodulation market.
Argent BioPharma gains approval for CannEpil™ in Germany, expanding access for patients with refractory epilepsy.
ONTOFORCE launches DISQOVER to streamline access and integration of Parkinson’s disease research data, accelerating insights and scientific collaboration.
GSK partners with ABL Bio for £2B+ deal to develop neurodegenerative therapies using Grabody-B BBB platform.
LIfT BioSciences names Mark Exley CSO to steer clinical launch of its neutrophil-based cancer immunotherapy.
Telix names Dr. Paul Schaffer CTO, boosting its radiopharma leadership with expertise in isotope technology.
SkyCell partners with Microsoft to embed AI in Teams, improving pharma logistics with real-time insights and alerts.
India’s pharma sector gains profit from Trump’s tariff relief on medicines, boosting exports and bilateral trade ties.
Jeune Aesthetics taps BOTOX® leader Marc Forth as CEO to drive growth in skin rejuvenation therapies.
ImmuCell taps IDEXX veteran Timothy Fiori as CFO to strengthen financial strategy and fuel future growth.
The KAFTRIO label expands in the EU to treat younger patients with non-class I mutations, allowing broader access in key countries.
AbbVie's RINVOQ becomes first oral therapy approved in EU for giant cell arteritis, offering new hope to patients.
EC approves subcutaneous RYBREVANT® + LAZCLUZE® for NSCLC with EGFR mutations using Halozyme's ENHANZE® drug delivery technology.
Rhythm’s Phase 3 trial shows major BMI reduction in rare hypothalamic obesity, FDA filing set for Q3 2025.
Troculeucel shows improved cognition and biomarker shifts in small Alzheimer’s study—Phase 2a now underway.
MaaT033 safely passes Phase 2b checkpoint in stem cell transplant patients, trial advances across Europe.
Veranova appoints Dr. Zugel as Global VP of Analytical Ops, boosting R&D with deep industry and GMP lab experience.
Health Canada grants Priority Review to AGAMREE, a potential first DMD treatment in Canada by end of 2025.
J&J’s nipocalimab shows durable gMG benefits, improving symptoms and reducing steroid use in Phase 3/OLE data.
Indivumed unveils novel cancer targets, expands leadership, and accelerates CRC drug discovery with AI and biobank.
Valneva and LimmaTech launch Phase 2 infant trial for S4V2, a vaccine to prevent life-threatening shigellosis.
Artiva appoints Dr. Banerjee as CMO to accelerate AlloNK’s development for autoimmune diseases.
ValoTx appoints Marcella Origgi as CEO to lead PeptiCRAd-1 trials and global immuno-oncology efforts.
The FDA accepted Outlook's ONS-5010 BLA with the Aug 27, 2025, PDUFA goal based on the clinical trial data.
Tolebrutinib delays MS disability in nrSPMS patients, NEJM publishes results; FDA review set for Sep 28, 2025
Cytosurge appoints Simon Egli as CEO; co-founder Pascal Behr to guide strategy as Board Delegate in 2025.
TRYVIO label updated by FDA, removing REMS and enabling broader use for resistant hypertension patients in retail.
Corvus welcomes biotech leader Richard van den Broek to its board, supporting ITK inhibitor clinical strategy.
Tonix and Makana team up to combine TNX-1500 with GE pig organs for xenotransplantation therapy development.
Grace Therapeutics receives FDA guidance supporting NDA submission for GTx-104 IV nimodipine in aSAH treatment.
Tevogen Generics launches to lower drug costs and expand U.S. pharma manufacturing; Sadiq Khan named interim lead.
IDEAYA launches Phase 1/2 expansion of IDE397–Trodelvy combo trial for MTAP-deletion urothelial cancer patients.
Pharma Live 2025 hits Mumbai April 17–19 with 35K+ attendees, 200+ exhibitors & keynotes on AI, diagnostics, APIs.
Pharma Now joined INTERPHEX 2025 in NYC, featuring Learning Labs, tech demos, and key pharma partnerships.
Arcutis CFO David Topper to retire in May; Latha Vairavan steps in to lead financial operations amid company growth.
Circio signs agreement with Lonza to evaluate circular mRNA technology in Lonza's expression system for protein production.
Jennifer Cote steps down as CFO of Harvard Bioscience; Mark Frost named interim replacement with effect in May.
CRL launches Single-Use Gamma Bags, engineered for gamma sterilization to meet pharma and biotech standards.
Icotrokinra shows significant skin clearance and safety in adolescents with plaque psoriasis in Phase 3 trial data.
Baxter introduces Hemopatch with room temperature storage, enhancing access for bleeding control in surgeries across Europe.
Shuttle Pharma advances PSMA-targeted cancer therapy with a new patent for PARP conjugates in metastatic prostate cancer.
Phase 1/2a trial of [212Pb]VMT01 starts monotherapy cohort for metastatic melanoma, including brain metastases.
Sun Pharma appoints Shaik Barak Tulla as SVP to drive commercial excellence and global business growth.
Eyestem reports promising vision improvement and safety in Phase 1 trial for dry AMD cell therapy Eyecyte-RPE™.
Roche's Columvi + GemOx was approved in the EU for relapsed/refractory DLBCL, doubling survival compared to standard therapy.
IDEAYA wins FDA backing to start Phase 3 trial of darovasertib in primary uveal melanoma patients.
Celularity supports CMS move delaying LCD on wound care, preserving Medicare access and enabling reform talks.
Cue and Boehringer collaborate on targeted T-cell therapy to transform autoimmune disease treatment.
Sanofi’s amlitelimab shows efficacy in inflammatory asthma; the pipeline expands with multiple Phase 2/3 studies in respiratory disease.
Lifecore welcomes Tom Salus as Chief Legal Officer, bringing 30+ years of legal and life sciences expertise.
MetaVia's DA-1726 achieves 6.3% weight loss with good tolerability in Phase 1 trial; shows promise for obesity and T2D.
Wiley teams up with Anatek to provide advanced spectral databases and tools to analytical labs across India.
Charlotte Moser joins Parexel as CMO, bringing 25+ years of leadership in clinical development and oncology research.
Vivani and Okava broaden OKV-119 development for ageing dogs, aiming to tackle obesity and diabetes and extend lifespans.
Telix’s TLX101 extends survival in recurrent glioma; early Phase 2 data confirms safety and efficacy at NMN Symposium.
Nobel Prize winner Dan Shechtman joins NeuroNOS’s SAB to support breakthrough ASD and Alzheimer’s research.
Dr. Rebecca Taub becomes advisor; Dr. David Soergel named CMO as Madrigal advances MASH treatment pipeline.
Industry leaders shared practical strategies and insights on aseptic processes at Pharma Now’s 2025 event in Ahmedabad.
Phathom adds Ted Schroeder to its Board to strengthen commercial strategy and expand VOQUEZNA®’s reach.
ACIP recommends Bavarian Nordic’s VIMKUNYA™ single-dose chikungunya vaccine for at-risk travellers and lab workers.
Scilex gains FDA orphan designation for colchicine in pericarditis, expanding beyond pain into rare inflammatory diseases.
Addex regains ADX71149 rights as Janssen exits the epilepsy program; the partnership officially ends with the return of asset rights.
Vabysmo improves vision and retinal swelling in angioid streaks. Patients meet Phase III endpoints with a good safety profile.
Dr. Robert Langer joins Decoy Therapeutics' SAB post-Salarius merger, enhancing innovation in peptide therapeutics.
Werewolf appoints Steven Bloom as CBO to drive growth as it advances breakthrough immunotherapy programs.
Design Therapeutics welcomes Dr. Storgard as CMO to advance clinical milestones for genetic disease treatments.
NewAmsterdam appoints pharma veteran Adele Gulfo to its board, enhancing leadership with decades of industry success.
Tevogen Bio collaborates with CD8 to develop a facility that enables in-house research and GMP cell therapy production.
BVI Medical's FDA-cleared Leos™ system revolutionises glaucoma care with advanced laser and imaging technology.
Africa CDC and WHO updated the mpox plan to boost control, vaccines, and resilience amid the global case surge.
Atea names Dr. Berman as Board observer under new deal with Radoff-JEC Group, who will support nominees at the 2025 vote
Lilly’s oral GLP-1 drug, orforglipron, shows strong results in type 2 diabetes and weight management trial.
Biotech leader Craig Wheeler joins Apellis Board to boost innovation and advance strategic vision in groundbreaking C3 therapies. Read More!
Enhertu plus pertuzumab demonstrates superior progression-free survival compared to THP in patients with HER2+ metastatic breast cancer. Read more!
Elutia initiates a multi-center study to assess the safety and performance of EluPro™ in patients undergoing CIED implantations and neurostimulation procedures.
Medicus expands SKNJCT-003 trial to 90 patients after IRB approval; interim data shows strong efficacy and safety for treating BCC.
Achieve’s cytisinicline Phase 3 results published in JAMA, showing strong efficacy and tolerability for smoking cessation; NDA planned for June 2025.
Jazz completes $935M Chimerix acquisition, gains promising brain cancer drug dordaviprone, under FDA Priority Review with a PDUFA date in August 2025.
A Myriad Genetics study published in the Journal of Clinical Psychopharmacology reveals that GeneSight testing led to a 39% reduction in psychiatric-related hospitalizations for depression patients.
NeuroNOS receives FDA Orphan Drug Designation for BA-102, a therapy targeting Phelan-McDermid Syndrome, a rare neurodevelopmental disorder linked to autism.
Roche to invest $50B in the U.S. over 5 years, creating 12,000+ jobs and expanding R&D, manufacturing, and diagnostics capabilities.
Sun Pharma & Ambuja Foundation start a 4-year water management project in Dhari, Gujarat, to improve irrigation, farming, and groundwater for 40 villages.
HUTCHMED completes Phase II enrollment for savolitinib in MET+ gastric cancer, aims for China approval in 2025.
Cassava announces Dr. Kupiec’s retirement and Dr. Moore’s appointment as Senior VP of Clinical Development, effective April 2025.
Rob Bancroft appointed CEO of AEON Biopharma, bringing 25+ years of life sciences leadership.
Rona Therapeutics gets NMPA approval for RN1871, an siRNA drug for hypertension, advancing to clinical trials in China.
BiomatiQ inaugurates world-class life science manufacturing facility in Hyderabad to advance life science manufacturing in India.
Abivax adds Dr. Dominik Höchli to Board, strengthening leadership ahead of Phase 3 ulcerative colitis data expected in Q3 2025.
Regeneron to nearly double biologics manufacturing through Fujifilm partnership, boosting U.S. capacity with a $3B+ investment and expanded job creation.
- Charles River reveals new cancer research platforms ahead of AACR 2025, including AI-driven analysis, humanised models, and 3D tumour screening tech.
1Cell.Ai launches OncoIncytes to power next-gen precision oncology with AI and single-cell insights.
- MetaVia’s DA-1726 demonstrates promising weight loss and safety in Phase 1 trial, with follow-up studies planned targeting Wegovy dropouts.
Tagworks starts Phase 1 trial of TGW101, a novel ADC; appoints Keith Orford as Chief Medical Officer.
Ascletis reports strong Phase Ib results for oral GLP-1R agonist ASC30 in obesity and submits 13-week Phase IIa study plan to FDA.
Gannet BioChem appoints Dr. Harry Rathore to its Board, bringing 35+ years of expertise to drive growth in specialty chemicals and CDMO services.
Roche's Chest Pain Triage algorithm earns CE mark, enhancing ACS detection and emergency care with AI-driven diagnostics via navify Algorithm Suite.
Voyager SPAC to merge with VERAXA Biotech, creating a Nasdaq-listed firm focused on next-gen cancer therapies.
DIOSynVax and ACM Biolabs team up on a universal bird flu vaccine, aiming for needle-free, global pandemic protection.
Clearmind launches CMND-100 clinical trial for Alcohol Use Disorder at Yale, Johns Hopkins, and IMCA, advancing psychedelic-based treatment research.
Coave Therapeutics appoints Romain Pettenaro to lead U.S. business development, enhancing its strategic focus on gene therapy innovation and growth.
Zealand Pharma begins Phase 2b ZUPREME-2 trial of petrelintide for overweight or obese adults with type 2 diabetes to assess efficacy and safety.
Zealand Pharma names Utpal Singh Chief Scientific Officer to lead peptide therapeutics discovery and drive innovation in obesity and metabolic diseases.
Pfizer to highlight 60+ studies at ASCO 2025, with new data on ADCs, BRAFTOVI®, XTANDI®, VERITAC-2, and epigenetic modulators.
Plus Therapeutics names Kyle Guse to its Board of Directors, bringing deep finance, legal, and biotech experience to support CNS radiotherapeutics strategy.
Cardiff Oncology secures U.S. patent for onvansertib-bevacizumab combo in mCRC; Phase 2 trial data expected in 1H 2025.
Artax Biopharma to present Phase 2a AX-158 psoriasis trial data in a prestigious late-breaking oral session at SID 2025, held in San Diego, CA.
Biomerica's Fortel® Ulcer Test for H. pylori detection gains approval from UAE Ministry of Health, offering rapid diagnosis for gastrointestinal diseases.
Mineralys publishes Phase 2 Advance-HTN results in NEJM, showing lorundrostat's strong efficacy in lowering blood pressure in resistant hypertension.
Calidi Biotherapeutics names Eric Poma, Ph.D., as CEO, marking a leadership transition to advance its virotherapy platform for cancer treatment.
Akoya and STCC partner on the SUPER study to identify spatial biomarkers that predict patient response to cancer immunotherapy in Singapore.
Inventiva identifies a biomarker that predicts responses to lanifibranor in MASH patients. Data was published in Clinical Gastroenterology and Hepatology.
Hikma sees strong growth across Injectables and Branded segments, reinforces U.S. manufacturing, and boosts R&D for long-term momentum.
Hikma sees strong growth across its Injectables and Branded segments, strengthens U.S. manufacturing, & accelerates R&D investments to drive long-term momentum.
AbbVie seeks FDA approval for TrenibotE, a novel short-acting neurotoxin with rapid onset designed for treating glabellar lines and attracting new users.
Actimed Therapeutics appoints Shaun Claydon as CFO to enhance leadership and advance innovation in treatments for muscle-wasting diseases. Read more!
Avidicure secures $50M in seed funding to advance its multifunctional antibody therapy for cancer, targeting innovative treatments with reduced toxicity.
DYNE-251 earns EMA orphan drug designation for Duchenne muscular dystrophy, strengthening Dyne's commitment to rare neuromuscular disease treatment.
FluidForm Bio publishes breakthrough CHIPS tissue platform in Science Advances, marking major progress in bioprinted, insulin-secreting therapies.
NurExone names Jacob Licht as CEO of Exo-Top and VP at NurExone, strengthening U.S. operations and completing its relocation from Alberta to Ontario.
DYNE-251 receives EMA orphan drug status for Duchenne muscular dystrophy, advancing Dyne’s efforts in rare neuromuscular diseases.
Beyond Air secures U.S. Patent for using gNO to treat NTM lung infections, offering a new treatment option for patients.
Merck KGaA, Darmstadt, Germany acquires SpringWorks Therapeutics for $3.9B to strengthen its rare tumor and U.S. healthcare market presence.
BEYONTTRA® (acoramidis) approved in the UK for ATTR-CM, offering near-complete TTR stabilization and improved patient outcomes, based on Phase 3 study success.
Portage Biotech reports strong PORT-7 preclinical results, prepares for human trials, and plans a PORT-6/PORT-7 combo to advance cancer immunotherapy.
Zentalis Pharmaceuticals begins dosing in DENALI Part 2 trial of azenosertib, targeting Cyclin E1+ PROC, aiming for accelerated approval if successful.
Explore Goldstab's comprehensive guide on Various BIS standards for UPVC Pipes to ensure compliance and reliable performance in your piping systems.
- Tevogen forecasts $1B first-year oncology sales and $10–14B over five years, highlighting its rapid, cost-effective drug development blueprint.
ADMA Biologics secures FDA approval for a new production process, boosting yields by 20%, enhancing efficiency, and advancing plasma-derived products.
Jade Biosciences finalizes Aerovate merger, secures $300M in funding, and advances JADE-001 for IgA nephropathy to transform autoimmune disease treatment.
PacBio licenses CUHK’s deep learning tech to expand methylation detection in HiFi sequencing, enabling 5hmC, hemimethylation, and 6mA profiling.
AAVantgarde names Rasmus Holm-Jorgensen as Chief Financial Officer to strengthen leadership, support strategic growth, and advance gene therapy programs.
AstraZeneca halts the CAPItello-280 Phase III trial of Truqap (capivasertib) in metastatic castration-resistant prostate cancer due to interim data failing to meet primary endpoints.
Krystal Biotech gets EC approval for VYJUVEK® to treat DEB, offering the first gene therapy for COL7A1 mutations in patients from birth across Europe.
Mesoblast appoints Lyn Cobley, former CEO of Westpac Institutional Bank, to its Board of Directors, bringing over 30 years of global financial expertise.
Roche's VENTANA TROP2 CDx, an AI-powered diagnostic device, earns FDA Breakthrough Designation for supporting NSCLC therapy & advancing lung cancer diagnostics.
Bayer announces Guru Ramamurthy as CFO of its Crop Science division, effective July 2025, bringing over 20 years of global finance leadership to the role.
Fablab names Mayur Hedaoo as Group CEO, advancing its global pharma & healthcare innovation with tech-driven, purpose-led leadership.
Adagene welcomes Dr. John Maraganore, former CEO of Alnylam Pharmaceuticals, as Executive Advisor to provide strategic guidance and support growth in antibody-based therapies.
Annovis Bio appoints Hui Liu as Director of Biostatistics, bringing 19+ years of clinical trial expertise across multiple therapeutic areas to leadership team.
CytoDyn will participate in the ESMO Breast Cancer 2025 Conference in Munich on May 15, highlighting advancements in breast cancer research and therapies.
Ardelyx names Merdad Parsey, M.D., Ph.D., to its Board of Directors, bringing biotech leadership and clinical expertise to advance the company’s mission.
INX-315 granted FDA Fast Track status for CCNE1-amplified platinum-resistant ovarian cancer, accelerating its path toward potential treatment approval.
Aclaris Therapeutics names Jesse Hall, M.D., as Chief Medical Officer to lead clinical strategy and innovation in immuno-inflammatory disease programs.
Therini Bio announces promising Phase 1a trial results for THN391, showing safety and tolerability in healthy volunteers for Alzheimer’s and retinal diseases.
Charles River’s new incubator welcomes 6 biotech innovators, offering mentorship and global resources to fast-track cell and gene therapies.
Abivax completes patient enrollment for its Phase 3 ABTECT trials of obefazimod, aiming to treat moderately to severely active ulcerative colitis.
Sandoz and Henlius sign a $301M global licensing deal to commercialize an ipilimumab biosimilar across the US, EU, and Japan, expanding their oncology reach.
Rinvoq (upadacitinib) gets FDA approval as the first oral JAK inhibitor for giant cell arteritis in adults, based on strong Phase III SELECT-GCA results.
AbbVie receives FDA approval for RINVOQ in GCA, supported by intense Phase 3 results showing higher sustained remission vs. placebo.
Merck begins $1B biologics facility in Delaware to produce KEYTRUDA and next-gen therapies, expected to create 500+ new jobs in the region. Read more!
Perspective Therapeutics begins Phase 1/2a trial, dosing first patient with [212Pb]PSV359 to evaluate safety and efficacy in FAP-α solid tumours.
Pharma Now launches its April–May 2025 magazine packed with expert insights, AI in pharma, regulatory updates, leadership stories & market trends.
Explore highlights from the Pharma Quality Excellence Awards 2025 in Mumbai, recognising top pharma innovators and quality champions.
Nipro India starts producing high-quality glass cartridges for dental and pen applications to meet increasing market demand.
Cassava appoints Dr. Bordey as SVP, Neuroscience to lead preclinical research on simufilam for TSC-related epilepsy and expand pipeline programs.
Mark F. Kubik joins Akari Therapeutics to lead business development for their ADC platform and AKTX-101 in oncology.
BioCardia enrolls first patient in Phase 3 CardiAMP HF II trial to evaluate autologous cell therapy for heart failure, advancing treatment options.
Dr. Olivier Brandicourt, former Sanofi CEO, joins Vaxcyte’s Board to support vaccine innovation and global commercialization strategy.
Windtree secures Houston property deal to generate rental income while advancing its cardiovascular and oncology drug pipeline.
Shinya Tsuzuki, formerly a top analyst at Mizuho Securities, joins Nxera Pharma as Head of Investor Relations, reporting to the CFO.
Foghorn Therapeutics appoints Dr. Neil Gallagher and Stuart Duty to its board, strengthening clinical and strategic leadership.
Adial Pharmaceuticals receives U.S. patent for using AD04 in genetically defined patients with alcohol or opioid-related disorders.
Elutia regains U.S. sales rights to its cardiovascular products, boosting margins and appoints Dwayne Montgomery to lead the new division.
BOTOX® Cosmetic expands its Confidence Project to support 250 women with training, mentorship, and $20K grants.
Breztri Aerosphere showed meaningful lung function improvements in Phase III asthma trials, with no new safety concerns.
MHRA approves VIMKUNYA for ages 12+, expanding chikungunya protection as Bavarian Nordic readies UK launch ahead of 2025 travel season.
ARS Pharma and ALK-Abelló team up to bring neffy® nasal epinephrine to more U.S. pediatricians, improving access for kids with severe allergies.
REC-4881 demonstrates up to 82% polyp burden reduction in FAP Phase 1b/2 trial, with a favorable safety profile and potential first-in-class promise.
Context Therapeutics appoints Dr. Karen Smith as interim CMO to lead clinical strategy and ensure continuity during a key leadership transition.
Autonomix concludes its first trial phase, showing significant pain relief, opioid reduction, and no serious adverse events in clinical trial participants.
Scorpius Holdings announces a $6M cost-saving plan, explores halal-certified CDMO facilities in Malaysia, and appoints key board members for global expansion.
Teva and Alvotech's SELARSDI gains FDA approval as an interchangeable biosimilar to Stelara, expanding treatment options for immune-mediated diseases.
PacBio and Chulalongkorn University launch Asia-Pacific's first newborn genome screening using HiFi WGS to detect rare conditions early in Thailand.
Moleculin secures two new U.S. patents for Annamycin, strengthening IP for its cancer therapy with no known cardiotoxicity or dose-limiting toxicity.
Immutep’s efti + KEYTRUDA® shows 17.6 months OS in head and neck cancer patients with CPS <1, outperforming standard treatments in clinical results.
Alterity's ATH434 receives FDA Fast Track designation for treating Multiple System Atrophy, accelerating its development and review process.
RetinalGenix leases lab space at MBC BioLabs to develop its DNA/RNA/GPS platform and repurpose drugs for neurodegenerative and ophthalmic diseases.
BioNTech names Ramón Zapata-Gomez as CFO, starting July 2025, to lead financial strategy and support upcoming oncology product launches and global growth.
Capricor clears FDA mid-cycle review for deramiocel in DMD-cardiomyopathy; no issues found. PDUFA approval decision expected by August 31, 2025.
Phase 1/2 trial data of IMNN-001 plus chemo for ovarian cancer to be published in *Gynecologic Oncology* and presented at ASCO 2025, highlighting key findings.
EU greenlights Calquence plus bendamustine/rituximab for untreated MCL in transplant-ineligible adults, based on ECHO trial showing 27% risk reduction.
INBS debuts Localised websites in Arabic, Italian, and Spanish to boost sales of its drug screening tech in Latin America, the Middle East, and Southern Europe.
Roche debuts Elecsys PRO-C3 test for fast, accurate liver fibrosis staging in MASLD patients, enabling earlier intervention and guiding new treatment options.
Mersana Therapeutics restructures, cutting workforce by 55% to prioritize breast cancer ADC programs and extend cash runway through mid-2026.
Galimedix completes SAD phase of GAL-101 Phase 1 trial, showing promising safety & pharmacokinetics for amyloid beta aggregation in neurodegenerative diseases.
Opus Genetics’ gene therapy for LCA5 receives FDA RMAT designation, expediting development for inherited retinal disease and advancing treatment options.
Essential Pharma appoints Duncan Ferguson as VP, Commercial, to lead strategy and growth in rare disease treatments with 25+ years of experience.
ENA Respiratory strengthens INNA-051's development with Kenny Simmen, PhD, and Alison Humbles, PhD, as strategic advisors for viral infection treatments.
Syndax’s Phase 2 data on revumenib for mNPM1 AML published in Blood, supports sNDA submission under FDA’s RTOR program for expanded label approval.
Theriva’s VCN-01 improves survival outcomes in Phase 2b VIRAGE trial for first-line metastatic PDAC, with manageable side effects and dose-dependent benefits.
Hepion pivots into diagnostics with CE-marked tests for celiac, HCC, H. pylori, and respiratory diseases, targeting $ 15 B+ market with strong growth potential.
Alvotech expects minimal financial impact from U.S. tariffs on imported pharmaceuticals, as costs fall to customers and not the company.
GRI Bio completes Phase 2a patient enrollment for GRI-0621 in IPF; interim analysis on track for Q2 2025, with topline results expected by Q3 2025.
Orchestra BioMed adds 27 patents to its AVIM therapy IP, advancing hypertension and heart failure treatments with FDA Breakthrough Designation.
EMA reviews Valneva’s chikungunya vaccine IXCHIQ® after reports of serious adverse events in adults 65+. Use remains unchanged for ages 12 to 64.
Trogenix adds Prof. Nada Jabado and Prof. Burkhard Becher to its Scientific Advisory Board, enhancing focus on pediatric oncology and immunotherapy.
DESTINY-Breast11 Phase III trial shows Enhertu plus THP improves pathologic complete response in high-risk HER2-positive early-stage breast cancer.
ARS Pharma launches neffy, a needle-free epinephrine nasal spray for kids with severe allergies, now available in U.S. with broad access and affordability.
Kartik Rajendran appointed MD of Abbott India, succeeding Swati Dalal post her resignation, effective June 14, 2025.
IMUNON opens first site for Phase 3 OVATION 3 trial of IMNN-001 in newly diagnosed advanced ovarian cancer patients at Washington University.
Amneal and Apiject partner to boost U.S. production of sterile injectables using advanced BFS technology at Amneal’s Brookhaven facility.
ReciBioPharm licenses NewBiologix’s Xcell-Eng-HEK293 cell line to boost AAV therapy production with high yield, quality, and scalability.
Seamless Therapeutics appoints biotech leader Alvin Shih to its Board to strengthen strategy and advance gene editing therapies.
Merck Animal Health partners with Kansas to invest \$895M in expanding its De Soto facility, boosting manufacturing and R\&D capabilities for animal health.
AVMAPKI FAKZYNJA CO-PACK gains FDA accelerated approval as the first treatment for KRAS-mutated recurrent LGSOC, marking Chugai’s seventh global approval.
Corvus reports Phase 1 data showing soquelitinib improves eczema symptoms with higher efficacy at 400 mg/day vs. placebo, even in patients with severe baseline disease.
Adial to meet with FDA in July to finalise Phase 3 plans for AD04, a precision treatment for Alcohol Use Disorder in genetically identified heavy drinkers.
Shuttle Pharma’s Ropidoxuridine nears 50% enrollment in Phase 2 glioblastoma trial; shows favorable safety and strong adherence with data expected in 2026
Conduit secures patent for a novel AZD5904 form with better solubility, extending IP and enabling development in infertility and inflammation-linked diseases.
Zepbound led to 47% more weight loss than Wegovy in a head-to-head Phase 3b obesity trial, with greater waist reduction and a favourable safety profile.
Addex and Indivior advance their GABAB PAM program to clinical stage after clearing IND-enabling studies, targeting treatment for substance use disorders.
FDA and CDC pause IXCHIQ® use in adults 65+ during safety review. Valneva backs global investigations and continues monitoring vaccine safety | Pharma Now.
AstraZeneca’s Trixeo Aerosphere for COPD approved in UK with low-GWP propellant, cutting carbon footprint by 99.9% | Sustainable care by Pharma Now.
REAL8 Phase 3 study shows once-weekly Sogroya® matches daily treatment for SGA, Noonan syndrome & ISS, offering a well-tolerated, effective option.
Amylyx shares 48-week Phase 2 HELIOS trial data for AMX0035 in Wolfram syndrome, showing sustained efficacy and favorable safety profile | Pharma Now.
Syndax Pharmaceuticals appoints Dr. Nicholas Botwood as Head of R&D and CMO, bringing 25+ years of oncology leadership experience from BMS and AstraZeneca.
Ascendis Pharma reveal 214-week Phase 2 data showing lasting benefits of TransCon PTH in adults with hypoparathyroidism and a strong safety profile | Pharma Now
Curium secures Swiss approval for PYLCLARI® to detect PSMA-positive lesions in prostate cancer patients, expanding its EU rollout to 12 countries.
Federal Circuit sends CRISPR patent case back to PTAB; Editas says ruling won't affect its CRISPR/Cas12a patents or licensing strategy.
Moleculin gets EMA approval to expand its Phase 3 MIRACLE trial for Annamycin in relapsed or refractory AML with sites across the US, EU, and Middle East.
Revive and DRDC advance Bucillamine research for nerve agent exposure; human trials may begin in late 2025 pending positive preclinical results.
ElevateBio names Ger Brophy, Ph.D., as Interim CEO and Board member, succeeding David Hallal. Brophy focuses on expanding genetic medicine capabilities.
Biodexa receives Orphan Drug Designation from the EC for eRapa in treating familial adenomatous polyposis (FAP), advancing toward Phase 3 study.
Dr. Launa Aspeslet appointed Chief Translational Officer at API to lead life sciences commercialization and support innovation across Canada.
ACELYRIN stockholders approve merger with Alumis to advance therapies for immune-mediated diseases. Completion expected in Q2 2025.
Capricor names Dr. Michael Binks as CMO to lead deramiocel's development for Duchenne muscular dystrophy and expand future pipeline.
Renovaro and Amsterdam UMC collaborate on blood platelet RNA diagnostics, aiming to revolutionize cancer detection using AI and ML technologies.
Connect Biopharma initiates Phase 2 Seabreeze study to test rademikibart for acute asthma exacerbations, aiming to improve lung function in asthma patients.
HCW9206 shows superior CAR-T cell performance; HCW Biologics prepares for commercial sales following FDA filing and new study data.
Oragenics gains HREC approval to start Phase II trial of ONP-002 for concussion treatment in Australia, advancing a new therapy for brain injury.
Erasca clears FDA IND for ERAS-0015, secures 3+ years of cash runway, and targets RAS-mutant cancers with promising therapies in early clinical stages.
BMB-101 eliminated drop seizures and boosted survival in DBA/2 mice, showing promise for drug-resistant epilepsy and SUDEP prevention.
CytoDyn reveals that leronlimab increases PD-L1 in tumors, potentially turning "cold" tumors "hot" and improving response to immunotherapy.
Join Asia Labex 2025 at BIEC, Bengaluru, from June 11-13, with Pharma Now as media partner, featuring 300+ exhibitors, 7,000+ products, seminars, and networking.
Explore the NutrifyToday C-Suite SumFlex 2025 in Mumbai, where global leaders in nutraceuticals, pharma, and policy unite to drive India's growth.
Pharma Now partners with the 4th GPCR-Targeted Drug Discovery Summit 2025 in Boston, offering exclusive coverage on next-gen GPCR therapeutics, featuring insights from industry leaders.
Tonix Pharmaceuticals appoints Joseph Hand as General Counsel & Executive Vice President of Operations, strengthening leadership ahead of TNX-102 SL launch.
Surrozen receives U.S. Patent for SWAP™ technology, targeting Wnt pathway receptors to enhance tissue repair and regeneration.
Therini Bio raises $39M in Series A to fund Phase 1b trials for THN391 targeting Alzheimer's and Diabetic Macular Edema.
Connect Biopharma launches Phase 2 Seabreeze STAT study to test rademikibart for treating acute COPD exacerbations with type 2 inflammation.
Hilary Kramer joins GT Biopharma's Board, bringing financial expertise to support strategic growth and advance its immuno-oncology pipeline.
Pharma Now is the official media partner for the 5th India Biopharma Leaders Conclave, June 5-6, 2025, in Hyderabad, focusing on biosimilars, biologics, and industry advancements.
Merck's KEYTRUDA achieved significant benefits in the Phase 3 KEYNOTE-B96 trial for platinum-resistant ovarian cancer, improving progression-free survival.
Autonomix secures U.S. patent for catheter-based nerve mapping and ablation system; trials for pancreatic cancer pain begin in 2025.
Amneal’s Brekiya autoinjector gains FDA approval as the first self-administered DHE treatment for migraines and cluster headaches.
Hikma sets 2030 revenue target of $5B, introduces new guidance and rebrands Generics as Hikma Rx at Ohio facility event.
Voyager's VCAP-102 capsid crosses the blood-brain barrier via ALPL receptor, enabling efficient CNS gene delivery in primates.
Pharma Now is the official media partner of the 2nd Annual Structure-Based Drug Design, June 3-5, 2025, in Boston.
Pharma Now is the official media partner of the 3rd Global Pharma Tech Summit 2025, Zurich, June 23–24, exploring pharma innovation.
BlueSphere Bio appoints Dr. Alan Korman as CSO to lead TCR-T cell therapy innovation, bringing 30+ years of expertise in immunology and drug discovery.
Novo Nordisk CEO Lars Jørgensen will step down amid market pressure; ex-CEO Lars Sørensen joins board meetings as observer.
BioMarin will acquire Inozyme Pharma for $270M in cash, adding late-stage therapy INZ-701 for ENPP1 Deficiency to its rare disease portfolio.
Pharma Now partners with the European Pharma Outsourcing Summit 2025 in Düsseldorf, covering insights on outsourcing, manufacturing, and supply chain.
Pharma Now has launched its official mobile app, offering real-time news, expert insights, and global pharma event updates—available on Google Play Store and App Store.
AstraZeneca’s Airsupra (albuterol/budesonide) reduced severe asthma exacerbations by 47% in the Phase IIIb BATURA trial.
Regeneron secures 23andMe’s Personal Genome Service®, Biobank, and health research assets for $256M, expanding its genetic research capabilities.
Daiichi Sankyo and Merck begin Phase 3 trial of I-DXd in advanced ESCC patients post-chemotherapy and immunotherapy.
Chugai Pharma Taiwan earns TFDA approval for PiaSky® to treat PNH in patients 13+ years old and 40+ kg, based on Phase III COMMODORE studies.
Rejuvenate Biomed starts Phase 2 trial of RJx-01 in older COPD patients with muscle weakness, backed by Wellcome Leap.
Alvotech appoints DNB Carnegie as liquidity provider for its SDRs on Nasdaq Stockholm to boost trading stability.
Acoramidis raises serum TTR early, lowering death risk in ATTR-CM patients.
Don Haut joins Arbor Biotechnologies to lead business strategy and partnerships for gene editing therapies.
Steven Johnson joins Zealand Pharma to lead development and regulatory strategies in obesity treatment innovation.
Rick Austin joins VERAXA Biotech as CSO to advance cancer therapy pipeline and BiTAC platform.
Oruka begins Phase 1 trial of ORKA-002, a long-acting IL-17A/F antibody for psoriasis; first participants dosed in safety and PK study.
GENFIT earns €26.5M milestone as Italy approves pricing and reimbursement for Ipsen’s Iqirvo® in PBC treatment.
Columvi + GemOx improves survival in relapsed DLBCL; FDA advisory panel requests more U.S. data before approval decision.
Marker’s MT-601 MAR-T cells expand better and show stronger clinical activity with lymphodepletion, as Phase 1 lymphoma trial enrollment accelerates.
Aligos Therapeutics names Laura Kavanaugh VP, Head of Legal, bringing 25+ years of biotech legal experience to support its clinical-stage programs.
AstraZeneca completes acquisition of EsoBiotec for up to $1B, boosting in vivo cell therapy capabilities via ENaBL platform.
Astoriom has expanded its Tramore, Ireland site to boost cryogenic and ICH-compliant stability storage, strengthening its global biorepository network.
Chugai’s Phase III TALENTACE trial shows TACE PFS benefit for unresectable HCC with Tecentriq, Avastin & TACE; OS data immature at prespecified first interim analysis.
Tonix starts Phase 2 OASIS trial of TNX-102 SL to reduce acute stress symptoms in trauma patients; funded by $3M DoD grant and UNC Trauma Institute.
Silo Pharma teams with Resyca for a study of its microchip nasal spray system for SPC-15, a novel PTSD prophylactic; IND-enabling studies ongoing.
Sandoz debuts Europe’s first ustekinumab biosimilar autoinjector, Pyzchiva®, boosting comfort and adherence in chronic disease treatment.
Trethera welcomes Dr. Benjamin Greenberg to its SAB to guide TRE-515's clinical development for optic neuritis and ADEM, rare autoimmune CNS diseases.
Dr. Gayathri Ramaswamy presented RIPK2 PROTAC degraders at DDC 2025, spotlighting Aurigene’s approach to targeted drug discovery and synthesis.
SynVivo appoints Dr. Richard Eglen to its Board, boosting scientific leadership to advance organ-on-chip tech for better drug discovery and development.
Sanofi to acquire Vigil Neuroscience for $470M, gaining rights to VG-3927, a potential TREM2-based treatment for Alzheimer’s. Deal to close in Q3 2025.
OSE teams with Inside Therapeutics & MiNT Lab on HexARN project to develop mRNA therapies, supported by €1.3M France 2030 grant via Bpifrance.
Medicus Pharma to begin Phase 2 UAE trial of non-invasive basal cell carcinoma treatment at four major hospitals.
Sernova forms Clinical Advisory Board led by Dr. Robert Gabbay to support the Cell Pouch platform for type 1 diabetes.
Astellas and Pfizer report 5- and 8-year data: XTANDI reduces death risk in metastatic prostate cancer by 30%.
PacBio and Haorui Gene partner to expand HiFi sequencing in China for clinical genomics and blood typing.
FDA approves Susvimo, Roche’s implant for diabetic retinopathy, offering vision protection with one refill every nine months.
Dianthus Therapeutics adds Simon Read, Ph.D., industry veteran, to its board as it advances antibody complement therapies for autoimmune diseases.
In an exclusive Pharma Now interview, Dr. Tathagata Dutta shares insights on pharma innovation, DNA research, leadership, and India's future in biologics.
Bachem, a Swiss peptide manufacturing company rolls out major investments across its site networks in US, UK and Switzerland
New biotech ABLi Therapeutics debuts to develop c-Abl kinase inhibitors, led by Risvodetinib for Parkinson’s and related disorders.
Vivoryon gains U.S. composition of matter patent for varoglutamstat, reinforcing its IP portfolio and advancing kidney disease treatment innovation.
CHMP recommends AstraZeneca’s Imfinzi for MIBC in the EU, citing NIAGARA trial results showing 32% risk reduction in disease progression.
Bio-Thera and Hikma receive FDA approval for STARJEMZA®, a Stelara® biosimilar, for plaque psoriasis and more.
C4X earns €8M from Sanofi for progress on oral IL-17A inhibitor, aiming to treat psoriasis and other inflammatory diseases with an oral therapy.
Rocket’s Phase 2 trial for Danon disease gene therapy is on FDA hold following a patient SAE and death. The company investigates and adjusts cash priorities.
Ocugen receives Rare Pediatric Disease Designation for OCU410ST, targeting Stargardt and other ABCA4-related eye diseases. Phase 2/3 trial to launch soon.
Biogen and City Therapeutics launched an RNAi drug collaboration targeting CNS diseases; the deal is worth up to $1B in milestones plus royalties.
ImmunityBio signs MOU with Saudi entities to deploy its FDA-approved Cancer BioShield in the Middle East, advancing immune-restorative therapies.
Novartis begins tender offer to acquire Regulus for $7/share plus CVR, expiring June 24, 2025; board recommends shareholder acceptance.
Altamira partners with undisclosed biotech to test its CycloPhore™ platform for delivering circular RNA; potential licensing may follow.
Acadia names Allyson McMillan-Youngblood SVP, Rare Disease Franchise, to drive DAYBUE® success and lead future product launch strategies.
VIVUS expands access to QSYMIA for weight loss, now offered at Costco Pharmacies with affordable pricing for Costco members.
Teva’s TEV-53408 earns FDA Fast Track for celiac disease, aiming to ease symptoms in patients on a gluten-free diet through IL-15 inhibition.
Coherus and STORM start Phase 1b/2 trials of STC-15 plus LOQTORZI for NSCLC, melanoma, and other cancers.
BC Platforms names Keith Collier as Chief Product Officer and Michele Lichtenfield as EVP & Head of Global Marketing to expand its Real-World Data impact and innovation.
Quantum BioPharma receives Australian ethics approval for a 60-patient trial testing FSD202 in chronic pain from MCAS, targeting major inflammatory disorders.
Telesis Bio licenses its high-throughput Gibson SOLA platform to Regeneron, enabling rapid, in-house DNA/mRNA synthesis to speed biologics R&D.
Charles River and CHDI Foundation extend their Huntington’s drug discovery collaboration, enhancing global R&D efforts with expanded AI and preclinical capabilities.
Alvotech and Advanz Pharma expand their biosimilar partnership with 3 new candidates, adding $180M in milestones and access to a $13.8B European market.
SCYNEXIS restarts Phase 3 MARIO trial for oral ibrexafungerp as step-down therapy for invasive candidiasis after FDA lifts clinical hold.
Eton Pharma's KHINDIVI™ gets FDA nod as first oral liquid hydrocortisone for kids 5+ with adrenal insufficiency.
FDA grants RMAT status to Candel’s CAN-2409 for localized prostate cancer after positive Phase 3 results showing improved disease-free survival.
ORIC-944 plus AR inhibitors shows early efficacy and safety in mCRPC Phase 1b trial, with strong PSA responses and mild to moderate side effects.
Taysha aligns with FDA on TSHA-102 pivotal trial design for Rett syndrome, backed by positive REVEAL data and Rett syndrome natural history insights.
Unbuzzd Wellness appoints MNP LLP for PCAOB audit as part of IPO prep, replacing Stern & Lovrics and advancing capital market plans.
Regeneron and Sanofi’s COPD drug itepekimab reduces exacerbations in the AERIFY-1 Phase 3 trial but misses primary endpoint in AERIFY-2.
BLA for patritumab deruxtecan in EGFR+ NSCLC withdrawn as HERTHENA-Lung02 trial misses OS endpoint; full data to be shared at ASCO 2025.
Auron Therapeutics doses first patient in Phase 1 trial of AUTX-703, a novel KAT2A/B degrader, for advanced AML and MDS treatment.
CC-42344 from Cocrystal Pharma shows strong antiviral effects against H5N1 avian flu, outperforming Tamiflu and advancing influenza treatment options.
Dr. Karen Chagin appointed Chief Medical Officer at Context Therapeutics, bringing 10+ years’ experience in T cell therapies for solid tumors.
CPHI Americas 2025 hosted 3,900+ attendees and 370+ exhibitors in Philadelphia, spotlighting pharma innovation, U.S. and LATAM markets, and global networking.
Pfizer's BRAFTOVI + cetuximab + mFOLFOX6 halved the risk of death in mutant metastatic colorectal cancer; OS improved to 30.3 months in the BREAKWATER Phase 3 trial.
AbbVie partners with the Chicago Cubs on the "Striking Out Cancer" campaign, donating $233 per strikeout to fight cancer.
Fate Therapeutics adds Neurocrine CFO Matthew Abernethy to its board; Timothy Coughlin steps down concurrently.
Nxera achieves a development milestone in its collaboration with Eli Lilly on diabetes, triggering a payment and progress toward $694M in milestones.
Novartis reports Kisqali reduces recurrence risk in early breast cancer, with greater benefit for younger, pre-menopausal patients.
VERIFY Phase 3 trial shows rusfertide significantly improves hematocrit control in polycythemia vera patients with good safety also met all endpoints.
Ziftomenib gets FDA Priority Review for treating relapsed/refractory NPM1-mutant AML. PDUFA date set for Nov 30, 2025.
In an exclusive Pharma Now interview, Dr. Rajput shares insights on pharma leadership, mentorship, and building solid professionals for the future.
Sandoz introduces WYOST® and Jubbonti®, the first interchangeable denosumab biosimilars in the U.S., expanding affordable access to osteoporosis and cancer care.
Novartis' Pluvicto shows significant rPFS benefit in PSMA+ mHSPC patients in Phase III trial, reinforcing its potential in earlier prostate cancer treatment.
Sutro Biopharma names Greg Chow as CFO. With 25+ years in finance and biotech, he’ll drive financial strategy and support ADC pipeline growth.
Dr. William Andrews named Chief Medical Officer at Catalyst Pharma, bringing 20+ years of biopharma and rare disease expertise.
Research backs Artelo’s FABP inhibitors as potential treatments for anxiety and depression with fewer side effects.
Elite Clinical Network names Christopher Brennan as CEO to drive growth and expand its clinical research site network and capabilities.
Dyadic names Joe Hazelton President to drive growth in ancillary proteins for life sciences, nutrition, and industry, aligning leadership with new focus.
Sernova names CEO Jonathan Rigby as interim Chair, continues financing talks, and announces CBO Dr. Modestus Obochi’s exit.
Roche’s Tecentriq-lurbinectedin combo cut disease progression risk by 46% in extensive-stage small cell lung cancer. The combo boosts survival in the ES-SCLC.
Neurocrine doses first patient in Phase 3 schizophrenia trial of NBI-‘568, triggering a $15M payment to Nxera, recorded as Q2 2025 revenue.
Renovaro gains U.S. patent to enhance its AI-driven platform for drug discovery and diagnostics, strengthening its precision medicine capabilities.
FABA launches India's first biotechnology finishing school, training graduates in lab skills, cell culture, and industry-ready soft skills in 27 days.
Chemomab gains new patents for nebokitug in China and Russia, boosting IP protection and advancing PSC treatment efforts globally.
Entrada appoints Dr. Maha Radhakrishnan to its Board, boosting leadership with deep drug development and biopharma expertise.
Rose Hill Life Sciences secures exclusive rights to Johns Hopkins' psilocybin-based therapies targeting motor function restoration in stroke and CNS injury patients.
Cognition Therapeutics initiates an expanded access program for zervimesine (CT1812) in DLB, funded by a philanthropic donation, across multiple U.S. sites.
Takeda gains EU approval for ADCETRIS® with ECADD in frontline Hodgkin lymphoma, based on the HD21 trial showing safer outcomes vs. standard care.
Amylyx earns FDA Fast Track for AMX0114 in ALS. Phase 1 trial underway to assess calpain-2-targeting ASOs’ safety, biomarkers, and neuroprotective effects.
Roche’s Evrysdi now approved in EU as a room-temperature stable 5mg tablet, offering convenience for SMA patients 2+ years old weighing at least 20kg.
Accumulus Synergy and Veeva Systems team up to boost global regulatory connectivity for life sciences firms via cloud interoperability.
Conduit and Manoira launch JV to test AZD1656 in animal osteoarthritis, boosting R&D for both human and veterinary markets.
Shuttle Pharma appoints veteran executive George Scorsis as Chairman to lead strategic oncology advancements.
Oncovita’s MVdeltaC receives FDA Orphan Drug Designation for pleural mesothelioma treatment.
Moleculin’s Phase 1B/2 trial shows promising Annamycin results in soft tissue sarcoma lung metastases.
HCW Biologics completes key deliverable, secures $7M upfront, and finalizes license agreement with WY Biotech for novel immunotherapy HCW11-006.
Frédéric Robert joins EUROAPI as Chief Commercial Officer to lead API Solutions and CDMO operations, driving growth and global strategy.
Tempest Therapeutics secures EMA orphan drug designation for amezalpat in hepatocellular carcinoma (HCC), following strong Phase 2 survival data.
Valneva presents positive six-month safety and immune response data for IXCHIQ® chikungunya vaccine in children.
Autonomix receives Uzbekistan approval to start next-phase PoC 2 Cancer Pain clinical trial for nerve ablation in cancer pain management.
Hikma introduces Triamcinolone Acetonide injectable (40mg/mL) in the US, targeting inflammation and autoimmune disorders.
Alvotech and Dr. Reddy’s partner to co-develop, manufacture, and commercialize a biosimilar to Keytruda®, a $29.5B blockbuster cancer drug.
SELLAS Life Sciences adds Drs. Amrein and Kentsis to its Scientific Advisory Board to strengthen cancer therapy development and clinical strategy.
Kailera strengthens its Board with Adam Koppel and Christopher Hite to boost leadership in advancing next-gen obesity therapies.
FDA grants Orphan Drug Designation to Avadel’s LUMRYZ™ for treating idiopathic hypersomnia with once-nightly extended-release sodium oxybate.
VeonGen (formerly ViGeneron) advances VG801 gene therapy for Stargardt disease with FDA Rare Pediatric Disease Designation and ongoing clinical progress.
Vertex shares new data showing ALYFTREK’s superior clinical and quality of life outcomes for CF patients, with benefits linked to sweat chloride reduction.
MIT and Recursion launch Boltz-2, an open-source biomolecular AI model with near-FEP accuracy at 1,000x speed for scalable drug discovery.
Join the London Biotechnology Show on June 18–19, 2025, at ExCeL London. Explore cutting-edge science, transformative innovation, and forward-thinking leadership in biotech.
Apellis and Sobi report 68% sustained proteinuria reduction with EMPAVELI in C3G and IC-MPGN; safety remains consistent at 1 year.
Biomerica names Eric B. Chin to Board of Directors and Chair of Audit Committee, succeeding Cathy Coste. Mr. Chin is the CFO at Akido.
Shawn Rose appointed Nkarta’s CMO & R&D Head as company pivots to autoimmune therapies; succeeds Dr. Shook, who steps down to pursue oncology roles.
On Pharma Now’s YouTube podcast, ex-Wockhardt President Pradnya Deshmukh reveals key lessons in pharma leadership, regulatory excellence, and work-life balance—essential listening for future industry leaders.
Pharma Now proudly participated in the 5th Indian Biopharma Leaders Conclave 2025, connecting with top industry leaders.
Biotech veteran Dr. Michael Kauffman joins FibroGen’s board to support pipeline growth, oncology focus, and strategic development.
Dr. Srishti Gupta to become Idorsia's CEO from July 1, 2025, bringing 20+ years of experience to drive long-term success and portfolio growth.
Dr. Jayne Morgan joins Micron Biomedical to support education and access to needle-free, dissolvable drug and vaccine delivery solutions.
George Medicines' WIDAPLIK, a triple-combo pill, gets FDA nod to help adults control high blood pressure with once-daily, single-pill therapy.
Lyell appoints new board and executive leaders to drive LYL314 development, enhance governance, and support future commercial growth in CAR T-cell therapy.
Merck’s enlicitide met all endpoints in two Phase 3 trials, reducing LDL-C in statin-treated adults without major safety concerns.
Merck’s ENFLONSIA wins FDA approval for preventing RSV in infants, showing strong efficacy in lowering infection rates and hospitalizations over five months.
CervoMed hires Dr. Marco Verwijs as EVP, Technical Ops to lead CMC and support Phase 3 and commercial prep of neflamapimod for dementia with Lewy Bodies.
Dr. Michael Vasconcelles joins Day One as Head of R&D to lead research, development, and medical affairs, supporting OJEMDA and pipeline expansion.
FDA clears IND for Monte Rosa’s MRT-8102, a NEK7-targeting molecular glue degrader for inflammatory diseases; Phase 1 trial to start soon.
Jazz’s Zepzelca-Tecentriq combo earns U.S. FDA Priority Review for first-line maintenance in extensive-stage small cell lung cancer; PDUFA set for Oct 7, 2025.
Xilio Therapeutics names Dr. Tunde Bello to its board, bringing 25+ years of oncology and clinical pharmacology expertise from BMS and Pfizer.
Inventiva appoints Renée Aguiar-Lucander to its Board. As former CEO of Calliditas, she led its $1.1B sale to Asahi Kasei and FDA approval of TARPEYO®.
Adial advances Phase 3 design of AD04 for Alcohol Use Disorder with help from Cytel; trial to target genetic subgroups and launch in late 2025.
AbbVie’s MAVYRET® gets FDA approval to treat acute HCV in patients 3+, becoming the first 8-week regimen with 96% cure rate and Breakthrough Therapy status.
Biogen highlights felzartamab’s Phase 3 progress in AMR, IgAN, and PMN, targeting CD38+ cells for precise treatment of autoimmune and kidney diseases.
Vivani Medical names Anthony Baldor as CFO, succeeding Brigid Makes, to drive growth and advance its long-acting drug implant programs.
Capricor clears key FDA inspection, progressing Deramiocel toward potential approval for Duchenne muscular dystrophy under priority review.
Vanessa Tolosa and Vivek Pinto join Precision Neuroscience to drive innovation and clinical strategy in the brain–computer interface technology.
Chemomab receives FDA alignment on CMC and toxicology plans, advancing nebokitug toward Phase 3 trials for primary sclerosing cholangitis.
AIM secures U.S. patent for manufacturing methods of dsRNA, including Ampligen, strengthening IP protection and advancing development through 2041.
BioNTech to acquire CureVac in a $1.25B all-stock deal, aiming to boost mRNA innovation for cancer and infectious diseases with expanded R&D power.
Starton opens enrollment for Phase 2a trial of STAR-LLD, a continuous low-dose lenalidomide therapy, aiming to improve outcomes in multiple myeloma.
Fabhalta® achieves Hb normalization, fatigue reduction, and no transfusions in PNH patients switching from anti-C5 therapies, with long-term safety confirmed.
Novo Nordisk to begin Phase 3 trials of subcutaneous and oral amycretin for weight management in early 2026 after positive Phase 2 results.
Merck initiates Phase 3 trial for V181, a single-dose quadrivalent dengue vaccine, enrolling first participants in Singapore.
Rakesh Kumar Sinha shares his leadership journey, vaccine manufacturing insights, and vision for pharma excellence at Biological E in this exclusive interview.
Kirti Ganorkar to succeed Dilip Shanghvi as Sun Pharma’s MD from Sept 2025. Shanghvi to continue as Executive Chairman, focusing on strategic growth.
BIOPLUS-INTERPHEX KOREA debuts Asia Bio Connect, a trilateral biotech forum linking Korea, China, and Japan for collaboration and global integration.
London Biotechnology Show 2025 kicks off June 18–19 at ExCeL, showcasing biotech breakthroughs, global experts, and 100+ exhibitors across the industry.
Roche advances prasinezumab to Phase III for early Parkinson’s, aiming for first disease-modifying therapy with promising long-term data.
Roche pauses ELEVIDYS dosing in non-ambulatory DMD patients after two fatal liver failure cases; ambulatory use remains unchanged.
Dupixent significantly outperformed Xolair in all CRSwNP and asthma endpoints in the Phase 4 EVEREST trial, showing superior efficacy and similar safety.
Syncromune appoints Kerri-Ann Millar as CFO to lead financial strategy and support clinical advancement of its SYNC-T immunotherapy for solid tumors.
Teva and Fosun Pharma join forces to develop TEV-56278, an anti-PD1-IL2 immunotherapy aiming to enhance cancer treatment with targeted immune activation.
Osmol secures EU patent for OSM-0205, a novel drug to prevent chemo-induced neuropathy and cognitive issues in cancer patients.
Hepion names Dr. Lbiati interim CEO to lead strategic growth and expand its diagnostic programs for celiac disease, HCC, and respiratory infections.
Centessa to begin Phase 1 trial of ORX142, an OX2R agonist, in sleep-deprived adults to assess safety and alertness effects. Data expected later in 2025.
Ocugen to begin Phase 2/3 trial of OCU410ST gene therapy for Stargardt disease following FDA clearance and positive Phase 1 safety and efficacy results.
Marker teams up with Cellipont for cGMP manufacturing of MT-601, advancing trials and prep for commercialization.
Acurx’s ibezapolstat shows promising CDI treatment results in Phase 2b trial, supporting move to Phase 3.
X-Chem appoints Stephen Fair as CFO and Maureen Hart as HR SVP to support growth and strengthen its global drug discovery operations.
Biocartis appoints Ben Svarczkopf as SVP Global Marketing to boost commercial growth and expand global reach in precision oncology solutions.
Relmada names urology expert Dr. Raj Pruthi as CMO to lead NDV-01 clinical development for NMIBC following positive Phase 2 data at AUA 2025.
Capricor earns FDA Orphan Drug Designation for BMD and reports BLA progress for Deramiocel in Duchenne Muscular Dystrophy ahead of August 2025 PDUFA date.
Synfini and O2nix Bio team up to develop first-in-class cancer therapies targeting FTSJ1, a key enzyme in metastatic cancer survival.
Dr. Edgar Charles joins Climb Bio as CMO to lead clinical strategy and development in immune-mediated diseases.
Eyestem submits Phase 1 report of Eyecyte-RPE to CDSCO after showing vision gains in dry AMD patients; Phase 2 to begin post regulatory approval.
Zealand Pharma’s GLP-1/GLP-2 agonist dapiglutide shows 11.6% weight loss and good safety in 28-week Phase 1b trial.
Akari Therapeutics gains Indian patent for PH1 ADC payload, expanding global IP for its novel immuno-oncology cancer therapies.
First patient dosed in Phase 3 trial of ifinatamab deruxtecan vs docetaxel for advanced prostate cancer by Merck and Daiichi Sankyo.
AbbVie's atogepant shows superior tolerability and efficacy vs. topiramate in Phase 3 TEMPLE migraine trial.
Biogen begins global Phase 3 BRAVE trial testing omaveloxolone in children under 16 with Friedreich ataxia (FA).
Aligos appoints pharma veteran Kieron Wesson, PhD, as VP and Head of CMC to bolster drug development efforts.
Roche’s SUNMO trial shows Lunsumio + Polivy combo significantly improves outcomes in relapsed LBCL vs. R-GemOx.
Novo Nordisk's STEP UP trial shows semaglutide 7.2 mg leads to 21% weight loss in obesity patients without diabetes.
FDA approves Dupixent for adults with bullous pemphigoid, providing relief from blisters, itch, and steroid use.
argenx's VYVGART SC wins EC approval to treat CIDP in adults, offering a targeted, self-injectable therapy with proven functional benefits.
Aptose gets $8.5M loan from Hanmi to advance tuspetinib in AML triplet therapy. Early trial data show strong safety, remissions, and MRD negativity.
Biocon’s Varma Bhupatiraju discusses vaccine approvals, regulatory strategy, and India’s role in shaping global pharma compliance and innovation.
CagriSema shows 22.7% weight loss over 68 weeks in the REDEFINE 1 trial; results published in NEJM and presented at the American Diabetes Association.
Novo Nordisk’s Mim8 shows safe transition from emicizumab in haemophilia A patients, with high patient preference and no washout or loading dose needed.
Chugai’s NXT007 showed no bleeds and strong safety in high-dose cohorts of the Phase I/II NXTAGE study in severe hemophilia A patients.
RAPT Therapeutics appoints Drs. Braunstein and Dombkowski to its board, boosting leadership as RPT904 advances in allergy and immunology trials.
Carisma and OrthoCellix merge to form a new company focused on advancing NeoCart®, a regenerative therapy for knee cartilage repair.
Dr. Andreas Moraitis joins MBX Biosciences as SVP of Clinical Development to lead strategy for endocrine and metabolic disorder therapies.
Anne Marie Cook joins Phathom as Chief Legal Officer to lead legal and governance strategy, bringing deep pharma legal and compliance expertise.
Vertex inks exclusive deal with Ono to co-develop and commercialize povetacicept in Japan and South Korea for IgAN and pMN.
Medicus Pharma Ltd. names Andrew Smith as Chief Operating Officer, bringing over 30 years of leadership in asset management and financial operations.
FDA grants accelerated approval to Datroway for EGFR-mutated NSCLC after prior targeted and platinum chemotherapy.
CytoDyn doses first patient in Phase II trial of leronlimab for relapsed colorectal cancer, marking a key step in its oncology program.
Lexeo Therapeutics partners with PXV and venBio to launch a non-viral RNA cardiac therapy venture, backed by $40M and targeting genetic heart conditions.
Revuforj earns FDA Priority Review for treating relapsed/refractory AML with mNPM1 mutation; PDUFA date set for October 25, 2025.
Merck’s WINREVAIR shows significant benefit in newly diagnosed PAH patients in Phase 3 HYPERION trial, reducing clinical worsening risk.
Novartis completes Regulus buyout, adding RNA therapy farabursen for ADPKD to its pipeline in a major nephrology and biotech expansion move.
Nicola Heffron joins Essential Pharma as Non-Executive Director, bringing 25+ years of rare disease and oncology expertise to strengthen board leadership.
Discover Dr. Mithilesh Trivedi’s inspiring journey through pharma leadership, humility, and spiritual wisdom in Pharma Now's powerful podcast.
Amicus secures Japan approval for Pombiliti + Opfolda to treat late-onset Pompe disease, expanding access to its enzyme-enhancing therapy in major markets.
Arbor Biotechnologies appoints Pfizer veteran Dr. Mikael Dolsten to its Board, boosting strategic leadership in gene editing and biotech innovation.
Amneal reports ADL-018 matches XOLAIR® in clinical trial for CSU; FDA filing expected Q4 2025, U.S. rights secured.
Scott Madel joins Biomerica as CCO to lead global growth of inFoods® IBS, drive payer strategy, and expand commercial reach in gastroenterology diagnostics.
argenx to begin registrational trial of ARGX-119 for CMS after Phase 1b shows safety, tolerability, and improved patient outcomes.
Addex invests CHF 2M in Stalicla to advance precision therapies for autism and CNS disorders; CEO Tim Dyer joins Board ahead of Phase 2 trials.
Hans Clevers and Barbara Schädler to retire from Roche, stepping down from pRED and Group Communications roles.
Circio and NeoRegen enter preclinical stage with circVec-NICT platform to enhance delivery of RNA therapeutics.
Biogen launches global Phase 3 PROMINENT trial of felzartamab in PMN to evaluate remission outcomes vs. tacrolimus.
Protagonist PN-477, a triple agonist peptide for obesity, with oral and injectable forms set for trials in 2026.
AbbVie to buy Capstan Therapeutics for $2.1B, securing in vivo tLNP CAR-T candidate CPTX2309 and RNA delivery tech for autoimmune disease therapy.
FDA approves Takeda’s GAMMAGARD LIQUID ERC, a 10% ready-to-use IG therapy with low IgA, for PI; U.S. launch in 2026, EU in 2027 as DEQSIGA.
Rocket Pharmaceuticals receives FDA IND clearance to begin Phase 1 trial of RP-A701 for BAG3-associated dilated cardiomyopathy.
FDA accepts Allergan’s sPMA for SKINVIVE by JUVÉDERM® to treat neck lines, aiming to expand its approved use beyond cheek smoothness in U.S. adults.
T-knife Therapeutics appoints Christoph Broja, Partner at EQT Life Sciences, to its Board of Directors, strengthening its leadership in TCR-T cancer therapies.
Outlook Therapeutics appoints biopharma veteran Bob Jahr as CEO to drive growth as it advances its retinal disease treatment pipeline
Jade Biosciences names Brad Dahms CFO to support growth, advance autoimmune pipeline, and build long-term stakeholder value.
GRI Bio finalizes patient enrollment for Phase 2a trial of GRI-0621 in IPF; topline data expected Q3 2025.
Sandoz invests $440M in a new Slovenia facility to boost biosimilars production, expand EU operations, and strengthen global distribution.
Alvotech and Advanz Pharma enter supply deal for AVT10, a Cimzia® biosimilar, with European launch expected in Q4 2025.
Vertex’s ALYFTREK® approved in the EU for CF patients aged 6+ with non-class I CFTR mutations; early access in Ireland, Denmark, and Germany.
Florida’s new law enables investigational stem cell therapies; Celularity is ready with FDA-registered inventory.
Jazz secures EC nod for Ziihera, the first HER2-targeted therapy conditionally approved in the EU for advanced BTC.
PharmaTech Expo 2025, with new Contract Manufacturing & Raw Material expos, will host 400+ exhibitors and 22,000+ visitors in Gandhinagar, August 5–7.
BioVersys partners with Shionogi in a global deal to advance BV500, a broad-spectrum NTM therapy, with potential milestones up to CHF 479M.
Pelthos Therapeutics completes merger with Channel Therapeutics, raises $50.1M, and begins trading on NYSE American as "PTHS" on July 2, 2025.
Instil Bio secures FDA IND clearance to begin Phase 1 trial of AXN-2510, a PD-L1xVEGF bispecific antibody, in relapsed/refractory solid tumors.
Regeneron’s Lynozyfic wins FDA approval for relapsed/refractory multiple myeloma after ≥4 prior therapies, with strong response data from LINKER-MM1 trial.
Theratechnologies to be acquired by Future Pak affiliate for $3.01/share + CVRs worth up to $1.19; total deal could reach $254M.
FDA grants priority review to Merck's sBLA for WINREVAIR in PAH, based on Phase 3 ZENITH trial showing 76% reduction in mortality and morbidity risk.
FDA approves Hikma’s TYZAVAN™, a room-temp, ready-to-infuse vancomycin for fast treatment of sepsis and other serious infections.
Nxera earns $4.8M in milestones from Centessa after IND clearance and Phase 1 trial start for OX2R agonist ORX142 targeting neurological conditions.
Thermal Energy wins $4.1M more for a pharma heat recovery project, now worth $5.6M, aiming to cut 2,038 metric tons of CO₂ annually.
Novartis reports Phase III GCAptAIN study results for Cosentyx® in giant cell arteritis; primary endpoint not met, but safety remains consistent.
MDxHealth appoints Michael Holder as Audit Chair and announces CFO Ron Kalfus to step down; Scott McMahan named interim CFO.
Essential Pharma names Simon Ramsden as CFO and Rob Smith as CTO to boost leadership and support growth in niche pharma markets.
Explore FDC Limited's award-winning training approach with Rajesh Bhattacharjee as he shares the PAC model, TNA methods, and pharma L&D insights.
AB Science to launch Phase 3 trial of masitinib for late-stage prostate cancer, with FDA and EMA approvals and biomarker-driven patient selection.
Immuthera adds top global experts to its new advisory board to advance Treg therapies for diabetes and autoimmune diseases.
Chugai and Gero enter $250M partnership to develop novel antibody therapies for age-related diseases using Gero’s AI target discovery platform.
Conduit Pharmaceuticals files 4 new patents for AZD1656 and AZD5658, leveraging AI with Sarborg to drive IP-rich asset development in autoimmune therapies.
Baxter appoints Andrew Hider as CEO, effective Sept 2025. Hider brings life sciences automation success from ATS to drive Baxter’s next chapter.
ImmunityBio gains UK approval for ANKTIVA in bladder cancer, marking its first international market nod after strong long-term response data.
SELLAS appoints Dr. Linghua Wang to its Scientific Advisory Board, enhancing expertise in cancer genomics, AI-driven research, and precision oncology.
Clearsynth Labs secures DST-TDB funding to establish India’s first large-scale deuterated chemical facility, promoting Make in India and self-reliance.
Coartem Baby wins Swissmedic nod as first malaria treatment for infants under 4.5kg, aiming to close a deadly care gap in Africa.
Join 60+ global experts in San Francisco for the first-ever West Coast edition of the Operationalize: Expanded Access Programs Summit.
Agios adds biotech veteran Dr. Jay Backstrom to Board of Directors to strengthen clinical and regulatory strategy.
Plus Therapeutics starts dosing patients in REYOBIQ™ LM trial to optimize radiotherapy for CNS cancer metastases.
Novo Nordisk files for EMA approval of 7.2 mg Wegovy®, citing 21% average weight loss in obesity trials.
Romaco Innojet unveils a heat recovery system for fluid bed processors, reducing energy consumption by up to 60% using a smart heat pump design.
Alvotech appoints Linda Jónsdóttir as CFO to lead global financial strategy, bringing vast experience in finance, healthcare, and corporate leadership.
Ascentage’s Lisaftoclax gets China NMPA nod as first Bcl-2 inhibitor approved for CLL/SLL, offering a novel at-home oral option for relapsed patients.
Pelthos launches ZELSUVMI™, the first FDA-approved at-home gel for treating molluscum contagiosum in adults and children aged 1 year and older.
Merck to acquire Verona Pharma for $10B, gaining Ohtuvayre®, the first novel inhaled COPD therapy in 20+ years, expanding its respiratory portfolio.
Aurigene fast-tracks bispecific antibody from development to patient dosing in under a year, showcasing advanced biologics capabilities.
AVP at Cadila, Mahesh Saini shares insights on FDA remediation, QA vs QC, and building world-class pharma plants in this inspiring video interview.
Drug Safety Symposium 2025: India’s PV Evolution
Oryzon wins patent approvals in Canada and Israel for vafidemstat to treat aggression and social withdrawal in CNS disorders.
Disc Medicine appoints Nadim Ahmed, CEO of Cullinan Therapeutics, to its Board of Directors.
Vertex’s non-opioid pain treatment JOURNAVX™ honored by Premier, Inc. as a 2025 Breakthrough Innovation.
Recludix Pharma expands leadership; Dr. Brian Hodous named CSO, joined by Dr. Vic Kadambi and Kristin Polsenski in elevated roles.
BiomX starts Phase 2b trial of BX004 in cystic fibrosis; first patient dosed to assess treatment for chronic P. aeruginosa lung infections.
Katalyze AI launches Digityze on Snowflake to automate pharma document processing and accelerate biomanufacturing insights.
Aegle appoints Dr. Scott Braunstein as Chairman to guide AGLE-102’s development for rare skin disease RDEB and lead strategic growth.
Iovance appoints Corleen Roche as CFO, bringing 30+ years of biotech financial leadership to support growth and TIL therapy advancement.
Dr. Yair Lotan joins Relmada as Chair of Clinical Advisory Board to guide Phase 3 development of NDV-01 for bladder cancer.
ENTOD and VESCOP sign MoU to bridge pharma academia-industry gap, promoting R&D in pharmaceuticals, nutraceuticals, and student-led innovation.
FDA approves Biocon’s Kirsty™ as first interchangeable NovoLog® biosimilar, expanding U.S. diabetes care options.
Mukul Mehta to become CFO of Novartis in March 2026, succeeding Harry Kirsch, who retires after 22 years of service and over a decade as CFO.
Madrigal secures USPTO allowance for Rezdiffra patent, covering weight-based dosing and extending U.S. IP protection through September 2044.
Onconetix to acquire Ocuvex in a merger deal; Ocuvex holders to own 90% of the combined firm. Merger aims to advance late-stage ophthalmic treatments.
Cue Biopharma’s CUE-101 + pembrolizumab combo shows 50% ORR, 2 complete responses, and 32-month mOS in HPV+ head and neck cancer Phase 1 trial.
Anselamimab didn’t meet its primary Phase III endpoint in AL amyloidosis but showed strong benefit in a key subgroup.
Voyager unveils new gene therapy to reduce Alzheimer’s risk by lowering APOE4 and delivering protective APOE2 via TRACER capsid.
Oragenics collaborates with Sterling Pharma Solutions for GMP production of ONP-002, aiming to advance clinical trials for concussion treatment.
INBS and SMARTOX expand partnership globally, launching SmarTest Patch for continuous, non-invasive drug detection.
Rocket’s RP-A601 gets RMAT status from FDA for PKP2-ACM after promising Phase 1 results in heart function, protein expression & patient quality of life.
NKGen and HekaBio team up to accelerate approval and rollout of NK cell therapy troculeucel for neurodegenerative diseases in Japan.
Vor Bio names Dr. Qing Zuraw as Chief Development Officer, adding 25+ years of global clinical leadership to its autoimmune drug development efforts.
Hyphens Pharma debuts Winlevi acne cream in Singapore and Malaysia, marking first Southeast Asia launch under exclusive deal with Cosmo Pharmaceuticals.
Ryan Richardson to leave BioNTech’s Management Board by Sept 2025 as part of a planned transition, marking the end of his strategic leadership since 2018.
Moleculin names Roche veteran Adriano Treve as Strategic Advisor to drive partnerships as Phase 3 AML trial advances toward key 2025–26 milestones.
This interview explores how pharma L&D is transforming into a strategic lever—integrating tech, data, and agility to boost sales outcomes and business goals.
Roche’s astegolimab shows significant benefit in Phase IIb ALIENTO COPD trial but falls short of statistical significance in Phase III ARNASA.
Sun Pharma’s ILUMYA shows significant efficacy in PsA Phase 3 trials; safety aligns with prior psoriasis data.
NKGen gains FDA Expanded Access approval for troculeucel in treating up to 20 patients with neurodegenerative diseases lacking effective therapies.
Tonix launches the “Move Fibro Forward” campaign to raise awareness and highlight unmet needs in fibromyalgia care after 15 years without new treatments.
Globus Medical appoints Keith Pfeil as CEO, sees 18.4% Q2 revenue growth; Nevro acquisition boosts sales, base business also rises.
Join global leaders in Boston on July 30–31 for the 5th Next Gen Gene Therapy Vectors Summit—exploring breakthroughs in viral and non-viral vector desig
Monte Rosa starts Phase 1 study of NEK7-targeting MRT-8102 to treat inflammation via NLRP3, IL-1β, and IL-6 modulation.
Takeda gets FDA 510(k) clearance for HyHub and HyHub Duo devices, simplifying HYQVIA infusion for PI and CIDP patients with needle-free vial transfer.
Autonomix Medical secures U.S. patent for smart torquer, boosting precision in minimally invasive, nerve-targeted treatments for high-need conditions.
AstraZeneca plans $50B U.S. investment to expand R&D and drug manufacturing, create jobs, and boost supply chain for next-gen therapies by 2030.
Biogen invests $2B to expand its North Carolina RTP facility, boosting advanced manufacturing to support its pipeline and global medicine supply.
Connect Biopharma expands its board, appoints biotech veteran Jim Schoeneck to accelerate development and commercialization of rademikibart.
Spruce Biosciences and HMNC Brain Health begin Phase 2 TAMARIND trial of tildacerfont for MDD, targeting stress-related depression using precision medicine.
DBV Technologies appoints James Briggs as Chief HR Officer to lead talent strategy and support the company's shift toward potential commercialization.
BioVie appoints Dr. Amy Chappell and Kameel Farag to its Board, strengthening leadership as it advances therapies for Parkinson’s, long COVID, and Alzheimer’s.
aTyr Pharma completes Phase 3 EFZO-FIT™ trial for efzofitimod in pulmonary sarcoidosis. Topline results expected in Q3 2025 to guide next steps.
Quanta names Vanessa Jacoby as CFO & CBO and begins dose expansion in Phase 1 trial of KRAS inhibitor QTX3034 for G12D-mutant solid tumors.
Rocket Pharma restructures to focus on AAV cardiovascular therapies, reducing workforce by 30% and delaying other programs.
Gefurulimab shows strong Phase III results in AChR+ gMG, improving MG-ADL scores with a favorable safety profile. Data to be shared with regulators.
Sanofi’s Sarclisa approved in EU with VRd for adults with newly diagnosed multiple myeloma eligible for stem cell transplant, showing deep, lasting response.
BioCardia requests PMDA consultation to review clinical data and discuss approval path for CardiAMP cell therapy for ischemic heart failure in Japan.
ICT Mumbai and ITRI sign an EOI for the ₹30 crore Mumbai Biocluster, a cutting-edge facility driving translational biopharma research, honoring Prof. M. M. Sharma.
Torrent Pharma expands its Shelcal® brand with Shelcal® Total—an adult nutrition supplement targeting bone, joint, muscle, and overall health.
FDA accepts sBLA and grants Priority Review to AstraZeneca’s Imfinzi for early gastric and GEJ cancers, with decision expected by Q4 2025.
GSK enters $500M deal with Hengrui Pharma to co-develop up to 12 drugs, boosting COPD and oncology pipelines for post-2031 growth.
Roche unveils new Alzheimer’s trial data and launches a Phase III study for early diagnosis and treatment using trontinemab and blood-based biomarkers.
Aclaris names Dr. Roland Kolbeck CSO, succeeding Dr. Joe Monahan amid retirement. Kolbeck brings 30+ years' expertise in immunology and drug development.
Tevogen unveils Tevogen.AI to enhance immunotherapy R&D using AI, in partnership with Microsoft and Databricks; aims to cut costs and speed development.
Apellis gets FDA approval for EMPAVELI to treat C3G & IC-MPGN, cutting proteinuria and helping kidney function in patients aged 12 and older.
SKYTROFA by Ascendis Pharma gains FDA approval for adult GHD, expanding its use beyond pediatric patients with weekly dosing convenience.
Bio-Rad appoints Rajat Mehta EVP of Global Commercial Operations, bringing deep diagnostics leadership experience.
Entera Bio gets FDA nod to use BMD as primary endpoint in Phase 3 EB613 trial for postmenopausal osteoporosis.
BMS and Bain Capital form NewCo with $300M to advance five immunology assets, targeting autoimmune diseases with unmet needs.
Novo Nordisk names Mike Doustdar as new CEO, effective August 7, following strong growth in International Ops.
Sanofi earns FDA orphan drug status for SAR446523, a GPRC5D-targeting antibody, aimed at treating relapsed or hard-to-treat multiple myeloma.
Altanine names Charles J. Andres, Ph.D., J.D., as CEO to lead clinical growth and innovation in drug delivery technologies across key therapeutic areas.
Asia’s top biopharma event returns to Seoul, Oct 15–17. Explore innovation, partnering, and global insights. Early-bird tickets available now!
Positive DSMB reviews allow Tenaya to advance TN-201 and TN-401 gene therapy trials for HCM and ARVC; updated results expected later in 2025.
Madrigal inks $2B licensing deal with CSPC for oral GLP-1 candidate SYH2086, aiming to start trials in 2026.
Neuronetics' study finds 70% of teens and young adults with depression improved using NeuroStar TMS, reinforcing its role as a non-drug option.
Intelligent Bio Solutions to deploy drug testing tech across the major London transport network, boosting safety at 14 sites.
RINVOQ (upadacitinib) hits primary and secondary endpoints in pivotal Phase 3 study for alopecia areata, showing major improvements in hair regrowth.
PharmaTech Expo 2025, held from August 5–7 at Helipad Exhibition Centre, Gandhinagar, showcased 400+ exhibitors and attracted over 22,000 professionals.
Plus Therapeutics to launch CNSide CSF assay in Texas this August, aiding early diagnosis of CNS metastases in cancer patients.
Charles River & BioTech Social may partner to offer CGT incubator participants up to $5M crowdfunding access via BioTech Funding Portal.
Oragenics selects Southern Star Research as CRO for Phase IIa mTBI trial of ONP-002, leveraging Australia's clinical and regulatory advantages.
Altasciences partners with VoxCell BioInnovation to integrate 3D bioprinted tissues in preclinical research, enhancing speed and human relevance.
Xencor appoints Dr. Raymond Deshaies to its board, adding decades of expertise in protein science and biopharma R&D to guide its antibody development programs.
Repligen teams up with Novasign to integrate machine learning into bioprocessing, enhance TFF systems, and advance digital twins for smarter manufacturing.
CoRegen names Dr. Sonal Gupta as CMO to lead clinical strategy and advance its SRC-3 cancer platform into the clinic, boosting biotech leadership
Certara appoints Dr. Chris Bouton as CTO to drive AI-powered biosimulation and boost model-informed drug development with a next-gen platform
GRI Bio reports early Phase 2a data for GRI-0621 in IPF, showing reduced fibrogenesis markers and no safety issues. Full results expected in Q3 2025.
Charlie Gayer to become BioCryst CEO on Jan 1, 2026, succeeding Jon Stonehouse after his Dec 2025 retirement. Gayer also joins the board with the new role.
Insights from Dr. Shuvankar Ballav on biosimilars, AI in compliance, and leadership in global regulatory affairs at IPCA.
Saudi Arabia becomes the first to approve PYRUKYND for alpha- and beta-thalassemia, expanding treatment access for adult patients.
MetaVia teams up with Syntekabio to optimize DA-1241, a GPR119 agonist showing promise in MASH and T2D, using AI-driven drug discovery tools.
Vor Bio names Dallan Murray Chief Commercial Officer. He brings 25+ years in biotech leadership, including Sarepta, Gilead, Biogen & Vertex.
Praxis’s vormatrigine shows strong efficacy and safety in Phase 2 study for adult focal onset seizures, signaling best-in-class potential.
New peer-reviewed case study highlights CannEpil®'s success in treating Lennox-Gastaut Syndrome, improving seizure control and quality of life.
Catalyst Pharmaceuticals names Dr. Daniel Curran to its Board to strengthen strategy, growth, and rare disease innovation.
FDA accepts sBLA for Breyanzi in relapsed/refractory MZL with Priority Review; decision expected by Dec 5, 2025, expanding CAR T options.
Systemair to exhibit hygiene AHUs and HVAC innovations at PharmaTech Expo 2025, Stall B-110, Hall 10, Gandhinagar, August 5–7.
Sanofi finalizes acquisition of Vigil Neuroscience to advance Alzheimer’s drug VG-3927 and expand neuro R&D.
Nxera Pharma unveils next-gen obesity pipeline with novel GPCR-targeted programs, including oral GLP-1.
Quantum BioPharma’s Lucid-MS passes Phase 1 safety trial with no adverse effects, advancing MS neuroprotection.
Conduit becomes CDT Equity, focusing on AI-driven biotech, drug repurposing, animal health, and digital asset strategy.
Silo Pharma launches a crypto treasury strategy with BTC, ETH, SOL, appoints Corwin Yu to lead and adds AI market tech.
Fortrea names Tracy Krumme as SVP of Investor Relations, bringing 30+ years of experience in CRO and healthcare to lead global IR strategy.
Clearmind gets IRB nod to start Phase 1/2a trial of CMND-100 for Alcohol Use Disorder at Hadassah Medical Center, expanding its global clinical program.
Mukesh Patale of Dr. Reddy’s shares his journey, bioprocessing insights, and leadership lessons in an inspiring Pharma Now podcast.
Sandoz partners with Elawan Energy on a 150 MW solar project in Spain to meet 90% of its European electricity demand and advance decarbonization goals.
Cormica appoints Dr. Kishore Hotha as GM of TPM Labs, bringing 20 years of global expertise in analytical sciences, regulatory strategy, and lab operations.
AbbVie is investing $195M to expand U.S. API manufacturing at its North Chicago site, boosting production for key neuroscience, immunology, and oncology drugs.
New Phase II study shows EscharEx strongly links wound bed preparation to closure in venous leg ulcers, highlighting improved healing outcomes.
Eric Risser named MacroGenics CEO and President, strengthening leadership to advance innovative antibody-based cancer therapies and strategic growth.
Onco360 partners with Regeneron to provide Lynozyfic™ for relapsed/refractory multiple myeloma, ensuring patient access & safe distribution through the REMS program.
Greenwich LifeSciences expands Phase III breast cancer trial into Romania, partnering with top oncologist Dr. Nicoleta Antone.
Alto Neuroscience adds Dr. Raymond Sanchez to its Board, bringing 20+ years of CNS drug development and biotech leadership experience.
Tonix Pharmaceuticals’ Tonmya™, a first-in-class non-opioid therapy, wins U.S. FDA approval as a new treatment option for adults with fibromyalgia.
Novo Nordisk’s Wegovy® gains U.S. FDA approval for treating MASH in adults with liver fibrosis, expanding its use beyond obesity.
Explore Dr. Ashok Kumar Patra’s journey from research labs in Orissa to leadership in India’s biopharma sector. Learn how AI, biosimilars, and resilience shaped his vision for biologics.
HUTCHMED completes enrollment in SANOVO Phase III trial of ORPATHYS® + TAGRISSO® as first-line treatment for EGFR-mutated, MET+ NSCLC in China.
Madrigal’s Rezdiffra wins EC approval as first EU therapy for MASH with moderate to advanced fibrosis, offering new hope for liver disease patients.
SpyGlass Pharma names Elizabeth O’Farrell as Independent Director & Audit Chair, adding 30+ years of pharma and biotech leadership expertise.
MMS collaborates with Friends of Cancer Research to develop decision frameworks for interpreting interim overall survival (OS) data in oncology trials.
Alvotech appoints Patrik Ling as VP Investor Relations Scandinavia, leveraging his 25+ years of life-science and equity analyst experience.
Aligos Therapeutics announces the appointment of Dr. Ramón Polo, PharmD, PhD, MBA, as Senior VP, Head of Global Regulatory Affairs, to lead regulatory strategies for ALG-000184.
PharmaTech & LabTech Expo 2025 concludes with 400+ exhibitors, 22K+ visitors, and major innovations in pharma and lab technology.
Crinetics Pharmaceuticals secures FDA Orphan Drug Designation for atumelnant, a novel ACTH receptor antagonist in development for congenital adrenal hyperplasia.
Parexel appoints Jim Anthony as Chief Commercial Officer and President of Biotech to drive growth, customer focus, and advance life sciences solutions.
The European Commission approves Mynzepli®, Alvotech’s biosimilar to Eylea®, for retinal diseases, key steps in expanding access to vision care in Europe.
PathAI and Moffitt Cancer Center team up to deploy AISight® Dx digital pathology platform, driving innovation and precision in cancer detection and research.
Krystal Biotech updates oncology program, advancing inhaled KB707 for non-small cell lung cancer with promising efficacy and FDA engagement.
AbbVie’s Phase 3 UP-AA program shows RINVOQ® helps restore scalp, eyebrow, and eyelash hair in severe alopecia areata, with a consistent safety profile.
Thermo Fisher launches a 375,000-sq-ft carbon-neutral site in Mebane, N.C., producing 40M pipette tips weekly to power U.S. medicine and diagnostics.
HUTCHMED appoints CFO Johnny Cheng as Acting CEO after Dr. Weiguo Su takes medical leave, ensuring leadership continuity and strategic progress.
Argent BioPharma’s ArtemiC™ achieved 85% survival in a severe viral ARDS study, reducing viral load and cytokine-driven inflammation.
FDA suspends Valneva’s IXCHIQ® license after four new adverse events. The company is investigating cases while assessing financial impact.
Eisai & Biogen launch LEQEMBI® in Austria & Germany, the first EU therapy targeting amyloid plaques and protofibrils in early Alzheimer’s disease.
Terumo India introduces smart infusion pumps with digital monitoring to boost ICU efficiency, drug accuracy, and critical care safety.
Immuneering signs clinical supply deal with Eli Lilly to study atebimetinib plus olomorasib in Phase 2 trial for KRAS G12C-mutant NSCLC patients.
Oculis appoints neuro-ophthalmology pioneer Dr. Mark Kupersmith and retina specialist Dr. Sebastian Wolf as Chief Medical Advisors to advance innovation.
Grace Therapeutics’ NDA for GTx-104, an IV nimodipine for aSAH, has been accepted by the FDA with a PDUFA target date of April 23, 2026.
Eli Lilly’s Verzenio plus endocrine therapy showed significant OS, IDFS, and DRFS benefits in the Phase 3 monarchE trial for high-risk early breast cancer.
Santhera signs a 5-year deal with Ikris to distribute AGAMREE for Duchenne muscular dystrophy in India, starting 2025 for patients aged 4 and older.
Outlook Therapeutics receives FDA CRL for ONS-5010 in wet AMD due to efficacy concerns, while expanding LYTENAVA™ commercialization in Europe.
Thermo Fisher earns R&D 100 Awards for its Stellar MS, PlasmidPro, and SteriSEQ products, advancing precision medicine, cell therapy, and biopharma research.
Eagle Pharmaceuticals appoints Abhinav Jain to its Board as part of an agreement with Nantahala Capital, with plans for a second new director by May 2026.
Sandoz launches generic rivaroxaban 10, 15, and 20 mg in Germany, expanding access after a key patent win and joining discount agreements to boost affordability.
FDA approves Sanofi’s Wayrilz (rilzabrutinib), the first BTK inhibitor for adults with immune thrombocytopenia unresponsive to prior treatments
Rotzinger PharmaPack unveils VarioFill, a compact, modular filling and capping platform for OTC pharma, cosmetics, and nutraceuticals—offering 50% space savings and rapid product changeovers.
Merck’s VERQUVO did not meet its primary endpoint in the VICTOR trial for stable HFrEF, but pooled data with VICTORIA showed significant benefit across patients.
Novo Nordisk’s STEER study shows Wegovy® lowers risk of heart attack, stroke, or death by 57% vs tirzepatide in obese patients with heart disease.
Novartis’ V-DIFFERENCE study shows Leqvio® enables early LDL-C goal achievement with 43% lower muscle pain risk, improving outcomes in high cholesterol patients.
Roche and Alnylam launch global Phase III ZENITH trial to test zilebesiran in 11,000 patients with uncontrolled hypertension for cardiovascular outcomes.
ELMACH unveils the EPI-3015 PDA, a modular blister machine with 100% inspection, servo precision, and tool-less changeovers for pharma, nutra, and personal care.
OMass inks $20M deal with Genentech to develop and commercialize new oral therapies for inflammatory bowel disease, with milestones over $400M.
FibroGen completes $220M sale of China subsidiary to AstraZeneca, repays debt, and extends cash runway into 2028 to support key clinical milestones
Jade Biosciences dose first cohort in Phase 1 trial of JADE101, a novel anti-APRIL antibody aiming to treat IgA nephropathy by targeting APRIL.
Maze Therapeutics appoints Misbah Tahir as CFO, adding 20+ years of biopharma financial leadership and $1B fundraising success at IGM Biosciences.
Step Pharma doses first participant in Phase 1b trial of dencatistat for essential thrombocythaemia, advancing CTPS1 inhibition for safer targeted therapies.
Opus Genetics names Rob Gagnon, CPA, MBA, CFO to drive financial strategy and growth in gene therapy and ophthalmic drug development.
Candel Therapeutics appoints immunotherapy pioneer Dr. Carl H. June to its Research Advisory Board to advance viral immunotherapy programs for cancer.
NMD Pharma names Dr. Ana de Vera as CMO to lead development of neuromuscular disease therapies, including Phase 2 trials of lead candidate NMD670.
Sanara MedTech appoints Seth Yon as President & CEO effective Sept 15, 2025, succeeding Ron Nixon, who remains Executive Chairman.
Vaxart announces Chairman Michael J. Finney’s retirement, marking his impactful leadership in advancing oral pill vaccine programs.
Valneva reports strong Phase 2 booster data for Lyme vaccine VLA15 with 100% seroconversion and favorable safety across all age groups.
Eisai and Biogen begin FDA rolling submission for LEQEMBI IQLIK, a weekly SC autoinjector offering a convenient home-use option for early Alzheimer’s treatment.
Outlook Therapeutics submits FDA Type A meeting request to discuss CRL on ONS-5010, seeking clarity on confirmatory evidence for U.S. approval.
Thermo Fisher acquires Sanofi’s Ridgefield, NJ facility, expanding U.S. sterile fill-finish capacity and strengthening its CDMO and CRO Accelerator™ platform.
Thermo Fisher completes $4B acquisition of Solventum’s Purification & Filtration business, expanding bioproduction and industrial filtration capabilities.
Vor Bio appoints Adi Osovsky, S.J.D., as General Counsel, bringing 17 years of biotech legal and compliance expertise to support company growth.
Medicus Pharma acquires Antev, gaining rights to Teverelix for prostate cancer and AURr. Adds $6B market potential and new board members in strategic expansion.
Join 800+ global experts at Cell & Gene Therapy International 2025 in Boston from Sept 16–18. Explore manufacturing, analytics, CDMO partnerships, AI, and more. Register now.
LIXTE adds new board members, appoints CFO, and relocates HQ to Florida, strengthening its mission to advance innovative cancer therapies.
Achieve Life Sciences’ NDA for cytisinicline to aid adult smoking cessation accepted by FDA, with a PDUFA target action date of June 20, 2026.
Adagene welcomes Dr. Axel Hoos, oncology leader and immunotherapy pioneer, as Executive Advisor to guide its antibody-based cancer therapy pipeline.
Artelo Biosciences reports positive Phase 2 CAReS results for ART27.13 in cancer anorexia-cachexia, boosting plans to secure a development partner.
Perspective Therapeutics appoints GSK U.S. Commercial President Maya Martinez-Davis as independent director, bringing oncology and pharma leadership expertise.
Charles River integrates Akadeum’s GMP-grade T cell isolation kit into its Cell Therapy Flex Platform, boosting cell viability and streamlining CAR-T development.
Allergan Aesthetics launches “Naturally You” campaign with providers and influencers to educate on safe, natural-looking outcomes of HA injectable fillers.
Silo Pharma has been granted an Australian patent for SPC-15, an intranasal therapy targeting PTSD, enhancing its global intellectual property portfolio.
AbbVie’s Phase 2 trial shows epcoritamab can be safely dosed outpatient in R/R DLBCL, with strong response rates in earlier treatment lines.
Autonomix’s first-in-human trial shows rapid, lasting pain relief in pancreatic cancer patients, with responders opioid-free at three months.
Roche’s Contivue® with Susvimo earns EU CE mark, showing sustained vision outcomes in nAMD with fewer treatments and strong long-term durability.
Explore Borosil Scientific’s lab solutions at analytica Anacon India 2025, Booth H4-B41, from glassware to LabQuest instruments and packaging.
Hinge Bio adds biotech leaders to advance GEM-DIMER™ programs and shares HB2198 preclinical proof in Scientific Reports for autoimmune diseases.
Walden Biosciences boosts its Phase 2 study of WAL0921 for rare kidney diseases with expert regulatory guidance and a NephCure patient partnership.
Arcutis files sNDA with FDA to expand ZORYVE® cream 0.3% use for plaque psoriasis in children ages 2–5, aiming to provide the first non-steroidal option.
Longeveron names Than Powell interim CEO and Dr. Joshua Hare Executive Chairman as the company advances pivotal stem cell therapy trials.
Agios announces FDA extended PYRUKYND sNDA review to Dec 7, 2025, after REMS submission to address hepatocellular injury risk in thalassemia patients.
Oncotelic shares pipeline updates and honors CEO Dr. Vuong Trieu, whose inventions include Abraxane® and Cynviloq™, shaping oncology and rare disease innovation.
Indaptus updates its INDP-D101 trial, showcasing its Decoy platform’s potential in cancer and viral diseases through multi-pathway immune activation.
Amneal gains FDA approval for risperidone ER injectable, with 180-day exclusivity and Q4 2025 launch, targeting schizophrenia and bipolar I disorder.
Roche reports new Vabysmo® data: sustained 4-year outcomes in nAMD and vision gains with lesion resolution in PCV, confirming durability and safety.
Join Agilent’s free webinar on Sept 17 to master polar compound analysis using HILIC, SPP, and reverse-phase columns. Reserve your seat now!
Sionna Therapeutics names Caroline Stark Beer CBO to lead business strategy, partnerships, and corporate development, advancing therapies for cystic fibrosis.
Moleculin begins EU dosing in Phase 3 MIRACLE trial evaluating Annamycin plus cytarabine for relapsed/refractory AML, targeting fast-track approval.
ElevateBio appoints Larry Lockwood, Ph.D., as CCO to drive commercial strategy, expand BaseCamp partnerships, and boost genetic medicine growth.
CHARM Therapeutics appoints Dr. Erkut Bahceci as CMO to lead clinical strategy for its next-gen menin inhibitor, targeting AML trials starting in 2026.
BioNTech & BMS share Phase 2 results of pumitamig in ES-SCLC, showing strong tumor responses, early PFS benefit, and manageable safety profile.
I-Mab boosts investment in givastomig, plans Phase 2 trial in 2026 with Phase 1b data readout early 2026, and announces key leadership changes
Lexicon shares new clinical data with FDA to support Zynquista resubmission, highlighting benefit-risk profile as adjunct therapy in type 1 diabetes.
Telix will resubmit NDA for glioma imaging agent TLX101-CDx in Q4 2025 after FDA guidance, with expedited review likely.
Phase 2 data show ANKTIVA reverses lymphopenia in NSCLC, significantly prolonging survival in patients resistant to checkpoint inhibitors.
Real-world data show ARS Pharma’s neffy nasal spray successfully treats 89% of anaphylaxis cases, matching epinephrine injection efficacy.
BioAtla announces FDA-guided pivotal trial for ozuriftamab vedotin in HPV+ OPSCC, targeting accelerated approval via ORR and full approval with OS benefit.
Medicus Pharma launches Phase 2 trial for non-invasive BCC therapy in the UAE, expands U.S./EU studies, signs HelixNano MoU, and acquires Antev for Teverelix.
Regeneron reports Phase 3 success for investigational allergen-blocking antibodies in cat and birch allergies, meeting primary and secondary endpoints.
NKGen Biotech acquires NKMax, gaining full control of its manufacturing, IP, and commercialization rights to expand NK cell therapy capabilities.
Teva’s emrusolmin receives FDA Fast Track for treating rare neurodegenerative disorder Multiple System Atrophy, accelerating its Phase 2 development.
Capricor addresses FDA’s public CRL for Deramiocel, its DMD cell therapy, and outlines plans to resolve issues and advance regulatory approval.
Silo Pharma secures Japan patent for SPC-15, licensed from Columbia University, strengthening its global IP portfolio for PTSD treatment.
Numab appoints Barbara Angehrn Pavik as CEO and Board member, succeeding co-founder David Urech, who transitions to Chair of the R&D Committee
Novartis plans to acquire Tourmaline Bio, adding pacibekitug, an IL-6 antibody for ASCVD, to strengthen its cardiovascular pipeline.
Amneal secures FDA approval and 180-day CGT exclusivity for risperidone extended-release injectable suspension in four strengths.
Sandoz resolved Regeneron’s patent dispute, paving the way for U.S. launch of its FDA-approved Eylea® biosimilar Enzeevu™ as early as Q4 2026.
Regeneron’s Libtayo plus chemotherapy improved survival in advanced NSCLC, with a 34% lower death risk and nearly double five-year survival rates.
Xilio advances tumour-activated IL-12 therapy XTX301 into Phase 2 for advanced solid tumours, earning $17.5M from Gilead, with cash runway into 2027.
Jazz’s Modeyso™ (dordaviprone) gains NCCN guideline inclusion as a treatment for recurrent H3 K27M-mutant glioma, following FDA accelerated approval.
HCW Biologics develops second-gen T-cell engagers targeting tissue factor and mesothelin in solid tumours, showing strong preclinical efficacy and safety.
Elutia to sell EluPro™ and CanGaroo® bioenvelopes to Boston Scientific for $88M, eliminating debt and funding its drug-eluting breast reconstruction pipeline.
Join 63,000+ professionals at CPHI Frankfurt 2025, the world’s largest pharma event, featuring 2,000+ exhibitors, new zones, and global networking.
Greenwich LifeSciences earns FDA Fast Track for GLSI-100 in HLA-A*02 HER2+ breast cancer, enabling rolling review and potentially earlier approval.
Artelo Biosciences reports preclinical data showing ART12.11 surpasses CBD in efficacy and bioavailability, advancing toward human studies in 2026.
Design Therapeutics appoints Justin Gover, ex-CEO of GW Pharma, to its Board as Arsani William steps down after guiding IPO and pipeline progress.
Kane Biotech surpasses enrollment goals with 28 participants in U.S. case series of its FDA-cleared revyve® Antimicrobial Wound Gel and Spray.
LIXTE Biotechnology buys $2.6M in Bitcoin and Ethereum, now holding 43.6% of its treasury in crypto while advancing its cancer drug pipeline.
Trethera finishes Phase 1 enrollment for TRE-515, a dCK inhibitor showing safety and early antitumor activity in advanced solid tumors.
FDA grants fast track to Sanofi’s SAR402663 gene therapy for neovascular AMD, aiming to speed development and improve treatment for wet AMD patients.
Merck reports positive Phase 3 STRIDE-13 results for CAPVAXIVE®, showing immune protection in high-risk children and adolescents against pneumococcal disease.
Amneal secures FDA approval for its sodium oxybate oral solution, expanding access to a standard of care therapy for narcolepsy patients.
Charles River announces alliances with PICI and CHLA, expanding its oncology CDMO role with preclinical services and support for pediatric cancer research.
Achieve Life Sciences names Dr. Mark Rubinstein as Interim CMO, succeeding Dr. Cindy Jacobs, to advance cytisinicline for smoking cessation.
Nacuity’s NPI-001 slows photoreceptor loss in Usher syndrome-related retinitis pigmentosa, showing strong Phase 1/2 trial results and safety profile.
Immix Biopharma names ex-Tanox CEO Nancy T. Chang to its board after her Goose Capital investment, strengthening its cell therapy expertise.
OSE and FoRT finish enrolling 105 patients for Combi-TED Phase 2 testing Tedopi® with nivolumab or docetaxel in advanced NSCLC. Results due 2026.
GRI Bio reports six-week Phase 2a results for GRI-0621 in IPF, showing stable lung function, anti-fibrotic biomarker trends, and continued trial progress.
Join Pharma Now × Pharmig UK for a free webinar on Annex 1 and microbiological compliance in India. Live on Sept 23, 2025. Register now for FREE!
Thermo Fisher introduces Olink® Target 48 Neurodegeneration panel, enabling absolute quantification of 41 biomarkers to drive precision research in neurology.
aTyr Pharma's Phase 3 EFZO-FIT™ trial of efzofitimod in pulmonary sarcoidosis missed its primary endpoint but demonstrated improved quality of life and steroid reduction.
Thermo Fisher introduces Gibco™ Efficient-Pro™ Medium (+) Insulin, AOF formulation, and simplified workflows for CHO-based biologics.
Raludotatug deruxtecan (R-DXd), Daiichi Sankyo and Merck’s CDH6-targeting ADC, earns FDA Breakthrough Therapy Designation in platinum-resistant ovarian cancer.
Monte Rosa and Novartis expand partnership with $120M upfront and up to $5.7B in milestones to advance molecular glue degraders for immune-mediated diseases.
Perspective Therapeutics doses first patient in Phase 1/2a [212Pb]VMT01 + Opdivo melanoma trial, aiming to improve survival for patients with metastatic disease.
Ocugen signs deal with Kwangdong for exclusive Korean rights to OCU400, with $7.5M upfront, milestones, 25% royalties, and plans for 2026 BLA filing.
EMA approves Rybelsus update highlighting cardiovascular benefits from the SOUL trial in type 2 diabetes.
Spyre starts Phase 2 SKYWAY trial of SPY072 for RA, PsA & axSpA, aiming for long-lasting, low-dose rheumatic therapies.
Atavistik Bio appoints Dr. Susan Pandya as CMO to guide ATV-1601 trials and advance its precision allosteric therapeutics pipeline.
Biocartis’ Idylla CDx MSI Test earns FDA PMA to guide OPDIVO and YERVOY use in MSI-H colorectal cancer patients.
Krystal Biotech’s VYJUVEK label now lets DEB patients of any age apply treatment at home with easier wound care flexibility.
SpyGlass names Anand Sundaram VP & Head of Commercial to lead launch strategy for its late-stage ophthalmic drug delivery platform.
Corbus’ CRB-701 earns FDA Fast Track for recurrent or metastatic HNSCC after chemo and PD-(L)1 therapy.
Parexel names Rob Goodwin COO to enhance clinical operations and drive excellence in global research solutions.
Oryzon secures new AU & EU patents for LSD1 inhibitors, boosting IP for oncology and CNS therapies.
Adagene amends deal with Exelixis to develop a masked ADC using its SAFEbody tech, targeting solid tumors with improved safety.
AstraZeneca’s Saphnelo met the primary endpoint in the Phase III TULIP-SC trial, showing disease reduction in lupus patients with a consistent safety profile.
Nxera Pharma and Cancer Research UK announce first patient dosed in Phase 2a trial of HTL0039732, a novel EP4 antagonist for advanced solid tumours.
Theratechnologies secures final court approval for its arrangement with Future Pak affiliate CB Biotechnology, with closing expected by September 25, 2025.
Baxter introduces the FDA-cleared Welch Allyn Connex 360 Vital Signs Monitor, designed to boost clinical efficiency, security, and patient data accuracy.
Takeda will be the first pharma company to transport medicines between Europe and the U.S. using VELA’s wind-powered sailing cargo trimarans, debuting in 2026.
AstraZeneca announced topline results from the Phase III RESOLUTE trial of Fasenra in COPD, study missed its primary endpoint but maintained safety profile.
Neuronetics announces New York State Medicaid will cover NeuroStar® TMS for major depressive disorder beginning Oct. 2025, expanding access to patients.
Biogen announces EU approval of ZURZUVAE®, the first treatment for post-partum depression, offering a novel 14-day oral therapy for mothers across Europe.
Roche announces agreement to acquire 89bio, expanding its CVRM pipeline with pegozafermin, a late-stage therapy for MASH and advanced liver fibrosis.
Eli Lilly’s SURPASS-PEDS trial shows Mounjaro® significantly improves A1C and BMI in children and adolescents with type 2 diabetes.
Eli Lilly’s ACHIEVE-3 trial shows orforglipron delivers greater A1C and weight loss benefits than oral semaglutide in type 2 diabetes patients.
Akari Therapeutics files patent for PH1 spliceosome payload ADC platform to advance innovative cancer treatments and improve outcomes.
Mumbai Biocluster launches PCG 2025, uniting global leaders to shape the future of peptides and complex generics on Sept 25–26.
ADARx names industry veteran Laura Shawver, Ph.D., as Board Chair to strengthen leadership and guide growth in RNA therapeutics development.
Invivyd appoints communications expert Kristie Kuhl as CCO to lead strategy and advocacy, strengthening its mission to combat viral diseases.
Palisade Bio’s PALI-2108 shows rapid clinical activity and safety in Phase 1b UC study, supporting its potential as a targeted anti-inflammatory and anti-fibrotic therapy.
Tonix secures global rights to TNX-4800, a Phase 2/3-ready monoclonal antibody offering single-dose, seasonal protection against Lyme disease.
Informa Markets unveils the finalists for the CPHI Pharma Awards 2025, celebrating innovation, sustainability, leadership, and women shaping the future of pharma.
Eight Roads Ventures hosts Scale-Up Health 2025, spotlighting biotech, AI, and value-based care as India enters a decade of healthcare transformation.
Vaxart names veteran CPA and ex-Deloitte executive W. Mark Watson as lead independent director to guide its innovative oral vaccine platform.
Labindia’s 1Labinfra unveils a Ductless Fume Hood with HEPA & multi-filter tech at Analytica India 2025, boosting lab safety & energy efficiency.
Epitopea appoints four renowned cancer immunology experts to its advisory board to advance RNA-based cancer immunotherapies.
Tonix reports positive FDA Pre-IND meeting on TNX-102 SL, advancing plans to develop a new treatment option for major depressive disorder.
Biogen to acquire Alcyone Therapeutics, enhancing CNS drug delivery tech with ThecaFlex DRx™ for SPINRAZA and future pipeline therapies.
Intellia finishes global Phase 3 HAELO trial enrollment for lonvo-z to treat hereditary angioedema, with topline data expected in early 2026.
Novo Nordisk’s REACH study shows Ozempic cut risk of heart attack, stroke, and related events by up to 25% vs. dulaglutide in Medicare patients.
Greenwich LifeSciences expands Phase III FLAMINGO-01 breast cancer trial to Ireland, partnering with Dr. Janice Walshe to advance GLSI-100 immunotherapy.
Grace Therapeutics strengthens IP estate with U.S. patent for GTx-104’s IV dosing regimen, extending protection to 2043 alongside FDA Orphan Drug exclusivity.
Vertex Pharmaceuticals announces reimbursement agreement with Italy’s AIFA, expanding access to CASGEVY® for eligible beta thalassemia and sickle cell disease.
Immix Biopharma surpasses 50% enrollment in NEXICART-2 trial of CAR-T therapy NXC-201 for relapsed/refractory AL Amyloidosis, with data presented at ASCO 2025.
Quantum BioPharma gains Health Canada approval for Qlarity, supporting energy, endurance, and cognitive health, expanding presence with U.S. brand unbuzzd™.
ARS Pharma secures PMDA approval in Japan for neffy® nasal spray to treat anaphylaxis, expanding global access following U.S. and European launches.
Regeneron will donate up to 500 doses of its Ebola therapy Inmazeb® to the WHO, ensuring free access for low-income nations supporting outbreak response.
Syndax’s revumenib is now a Category 2A recommendation in NCCN AML guidelines for relapsed NPM1-mutated patients, with FDA priority review decision expected by Oct 2025.
Alvotech and Fuji Pharma receive Japan approvals for three biosimilars: denosumab, golimumab , and aflibercept, expanding their partnership portfolio.
Avalo Therapeutics appoints Kevin R. Lind to its Board, strengthening leadership as AVTX-009 Phase 2 trial for hidradenitis suppurativa progresses.
Actuate Therapeutics submits updated elraglusib data to FDA for upcoming FDA and EMA talks on pancreatic cancer therapy progress.
Lexicon sends extra Zynquista® data to FDA to support benefit-risk profile for type 1 diabetes; FDA feedback expected later this year
Plus Therapeutics gets $1.9M advance from CPRIT to support CNS cancer trials and diagnostic development.
Oryzon sponsors first study on Phelan-McDermid syndrome to assess its impact and guide development of new therapies.
Roche’s phase III evERA trial shows giredestrant plus everolimus significantly improves PFS in ER+ HER2- breast cancer, with positive safety profile and OS trend.
AstraZeneca and Amgen’s Tezspire receives CHMP recommendation for EU approval in chronic rhinosinusitis with nasal polyps, based on phase III WAYPOINT trial.
Alvotech and Advanz Pharma announce CHMP’s positive opinion for Gobivaz®, a Simponi® biosimilar, covering multiple inflammatory diseases across the EU and EEA.
AstraZeneca’s Koselugo receives CHMP backing for EU approval to treat adult NF1 patients with symptomatic, inoperable plexiform neurofibromas.
Alvotech announces CHMP positive opinion for AVT03, its proposed biosimilar to Prolia® and Xgeva®, with commercialization by STADA and Dr. Reddy’s in Europe.
Fortrea expands its Board with veteran William Sharbaugh, bringing 30+ years of pharma and CRO expertise to strengthen governance and drive growth.
Abselion expands its Amperia™ platform with the new Protein G Total Antibody Quantification Kit, enabling rapid, user-friendly, and accurate measurement across diverse antibody formats.
BPGbio strengthens leadership by bringing back NAi platform co-inventor Slava Akmaev as COO and Chief AI Officer to advance AI-driven drug discovery.
Biotech leader NeuraClick names industry veteran Daniel M. Bradbury to guide strategic and metabolic programs for its neurotherapeutics pipeline.
Amneal secures FDA approval for generic 0.01% bimatoprost ophthalmic solution, offering more accessible glaucoma and ocular hypertension treatment options
Vor Bio appoints Navid Z. Khan, Ph.D., as Chief Medical Affairs Officer to lead medical strategy and support autoimmune disease treatment programs.
Trethera secures $1.8M NIH funding to advance TRE-515 preclinical studies for Crohn’s disease, supporting development of a first-in-class oral therapy.
Sanofi commits $625M more to Sanofi Ventures to boost investments in biotech and digital health, accelerating next-gen therapies and innovation.
Biogen shares FDA feedback on high-dose nusinersen for SMA; clinical data intact, resubmission planned to advance global regulatory approvals.
Vertex teams up with Jayson Tatum to spotlight JOURNAVX, the first new non-opioid pain medicine class in 20+ years, approved by FDA in 2025.
Seres gets FDA feedback to finalize SER-155 Phase 2 for bloodstream infection prevention, while extending its cash runway into mid-2026.
Veru gains FDA clarity for enobosarm in obesity: approved endpoint is incremental weight loss with GLP-1 RAs, preserving muscle and driving fat reduction.
Allergan Aesthetics expands SKINVIVE® to 57 global markets in 2025, highlighting hydration, radiance, and natural skin quality.
Bristol Myers Squibb’s Phase 3 trial of iberdomide with daratumumab and dexamethasone shows significant MRD results in relapsed or refractory multiple myeloma.
Hanson Wade’s Genome Editing Therapeutics Summit 2025, Sept 30–Oct 1 in Boston, gathers 100+ experts to explore breakthroughs, clinical advances, and regulatory strategies in gene-editing therapies.
Eminence Business Media hosts the 7th Pharma Manufacturing & Automation Convention on Oct 8–9 in Hyderabad, uniting 250+ leaders to explore lean, digital, and efficient pharma manufacturing.
The 8th Neuropsychiatric Drug Development Summit gathered 150+ leaders to advance precision psychiatry, neuroplastogens, and novel therapies shaping the future of mental health treatment.
The Pharma Manufacturing & Automation Excellence Awards 2025, themed F.A.S.T., will recognize outstanding individuals and organizations driving innovation, sustainability, automation, and talent growth in pharma.
Cell & Gene Therapy International 2025 gathered global leaders, 220+ exhibitors, and top innovators in Boston to advance cell and gene therapy R&D, manufacturing, and commercialization.
Sapu Nano starts Phase 1 trial of Sapu003 to improve Everolimus absorption and breast cancer treatment outcomes.
Invivyd adds Dr. Paul B. Bolno, CEO of Wave Life Sciences, to its Board of Directors and Compensation Committee, boosting biotech leadership.
Dr. Park CDMO teams with Thermo Fisher to equip a viral vector facility, enhancing AAV production and cell therapy capabilities.
Zealand Pharma appoints Rachel James-Owens as VP of Corporate Communications & Media Relations with 20+ years of pharma experience.
Cell & Gene Therapy International 2025 gathered global leaders, 220+ exhibitors, and top innovators in Boston to advance cell and gene therapy R&D, manufacturing, and commercialization.
Novartis' new Kesimpta study data show durable efficacy, 90%+ NEDA-3 rates, and no new safety concerns in relapsing multiple sclerosis.
Chugai seeks MHLW approval for Avastin in NF2, backed by Phase II BeatNF2 trial showing hearing improvement and disease control in patients.
Acadia reports Phase 3 COMPASS PWS trial results: intranasal carbetocin showed no efficacy over placebo but maintained a safety profile in PWS patients.
The TGA has approved LEQEMBI® (lecanemab) for early Alzheimer’s in Australia, reversing a prior rejection. Eisai and Biogen will co-commercialize the therapy.
BIOPLUS-INTERPHEX KOREA 2025, running October 15–17 at COEX, Seoul, will host 12,000+ leaders with 33 sessions, keynotes by Dr. Robert Hariri & Dr. David Berry, and 550+ exhibitors driving biopharma innovation.
Concept Life Sciences opens expanded state-of-the-art drug discovery site in Chapel-en-le-Frith, uniting chemistry, ADMET, and biology with 130 scientists to accelerate life-changing therapies.
Annovis Bio strengthens leadership with Mark Guerin as CFO to support buntanetap development for neurodegenerative diseases.
Australia approves MediWound’s NexoBrid for burn care, expanding its global presence and offering non-surgical eschar removal.
Boehringer advances Numab’s T cell engager for lung and GI cancers, triggering milestone payment and preclinical development.
Nuvectis Pharma adds biotech leader Juan Sanchez, MD, to its Board of Directors to support oncology pipeline and Phase 1b program development.
LB Pharmaceuticals appoints William Kane and Rekha Hemrajani to its Board to guide LB-102 development for schizophrenia and bipolar depression.
Sethera Therapeutics appoints Drs. Jeffery Kelly and Alexander Klibanov to the SAB, joining Dr Robert Langer to guide peptide therapeutic innovation.
Vertex Pharmaceuticals reports major progress in IgAN, AMKD, and ADPKD programs, including FDA breakthrough designation and new Phase 2/3 clinical trials.
Theratechnologies has been acquired by CB Biotechnology, a Future Pak affiliate, with shareholders receiving US$3.01 per share plus CVRs worth up to US$1.19.
CNSide Diagnostics, a Plus Therapeutics subsidiary, signs UHC deal to cover CNSide® CSF tumour cell test, boosting access for over 51M Americans.
Medicus Pharma updates on FDA Type C meeting for Skinject D-MNA, highlighting 505(b)(2) regulatory pathway support, Phase 2 trial progress, and Teverelix acquisition for advanced prostate cancer.
Alan Sandler named CDO as Revolution Medicines adds new U.S. and Europe GMs to strengthen oncology development and commercial readiness.
Usman “Oz” Azam becomes Cue Biopharma CEO, while Daniel Passeri transitions to Strategic Advisor, driving development of autoimmune and T cell therapies.
J. Kevin Judice joins Revagenix board as Andrew McCandlish steps down, bringing biotech expertise to advance next-generation antibiotic development.
Andrew Bayliffe joins Quotient Therapeutics as CDO to lead somatic genomics-based drug development and advance breakthrough medicines.
Christophe Arbet-Engels joins Altimmune as CMO to lead clinical development of pemvidutide, advancing Phase 3 trials in liver and metabolic diseases.
The inaugural PCG 2025 Symposium in Mumbai gathered 400+ pharma leaders, regulators & innovators to shape India’s future in peptides & complex generics.
AbbVie begins construction of a new $195M API plant in North Chicago, expanding U.S. production capacity for neuroscience, immunology, and oncology medicines.
RAPT Therapeutics secures FDA clearance to launch Phase 2b prestIgE trial of RPT904, a novel anti-IgE antibody targeting food allergies and allergic diseases.
Enanta Pharmaceuticals’ Phase 2b trial of zelicapavir for RSV shows faster symptom resolution, reduced hospitalisation, and strong safety in high-risk adults.
Tonix Pharmaceuticals, an intranasal oxytocin therapy for Prader-Willi syndrome, is entering Phase 2 after FDA IND clearance and rare disease designations.
Novartis begins $48/share cash tender offer for Tourmaline Bio, with expiration set for October 27, 2025, subject to regulatory and shareholder conditions.
Novartis will launch a U.S. direct-to-patient platform on Nov 1, 2025, offering Cosentyx at a 55% discount to improve affordability and expand access.
Autonomix starts FDA-required GLP preclinical study at CBSET for its Sensing & RF Ablation System, targeting pancreatic cancer pain and broader applications.
Roche announces positive TSIX study results for its 6th-gen Troponin T test, improving heart attack diagnosis and triage in crowded emergency departments.
Nxera earns a $10M milestone from AbbVie after identifying new GPCR ‘hit’ molecules, marking the second achievement in their neurology R&D collaboration.
AbbVie has submitted a BLA to the FDA for Pivekimab sunirine (PVEK) in BPDCN, supported by Phase 1/2 CADENZA trial data and Breakthrough Therapy designation.
Tonix Pharmaceuticals appoints Ganesh Kamath as Head of Market Access, bringing extensive global experience in pricing, market access, and finance.
Pfizer signs historic deal with the Trump Administration to lower U.S. drug prices, offering up to 85% discounts via TrumpRx.gov while focusing on new cures.
Novartis’ Rhapsido gains FDA approval as the first oral BTKi for CSU, giving patients a new treatment option when antihistamines fail.
AbbVie launches $70M expansion at its Worcester Bioresearch Center, enhancing U.S. biologics manufacturing and creating new jobs.
FDA accepts Pharming’s sNDA for leniolisib in children 4–11 with APDS, granting Priority Review with a PDUFA target date of Jan 31, 2026.
SpectronRx’s Actinium-225 Trinitrate Master File receives Health Canada review, enabling Canadian clinical trials and simplifying access to this critical alpha-emitting isotope for targeted cancer therapies.
Hinge Bio partners with Kyorin to develop and commercialize HB2198 for autoimmune diseases in Japan, starting with systemic lupus erythematosus (SLE).
Disc Medicine submits an NDA to FDA for accelerated approval of bitopertin in patients 12+ with erythropoietic protoporphyria (EPP), requesting Priority Review.
EMA PDCO gives positive opinion for Acurx’s ibezapolstat in children with C. difficile infection.
Phase 3 HYPERION trial shows WINREVAIR significantly lowers risk of clinical worsening in newly diagnosed PAH patients on background therapy.
Pharma Now & Pharmig UK present Pharmig India 2025 in Ahmedabad (Dec 2) and Hyderabad (Dec 4), uniting 300+ QA/QC leaders, microbiologists, and regulators for actionable insights on contamination control and Annex 1 execution.
Starton Therapeutics elevates Rod Hartwig to Vice President of Research & Development/Manufacturing, succeeding retiring Chief Manufacturing Officer Andy Rensink, effective October 2025.
Nacuity Pharmaceuticals’ NPI-001 granted FDA Breakthrough Therapy Designation for retinitis pigmentosa, highlighting its potential to slow vision loss and accelerate development of new treatment options.
George Medicines grants Biolab exclusive rights to commercialize GMRx2 in Brazil — an innovative triple combination pill for hypertension designed to improve early treatment outcomes and cardiovascular care.
Roche’s Tecentriq (atezolizumab) with lurbinectedin (Zepzelca) gains FDA approval as the first combination therapy for first-line maintenance in extensive-stage small cell lung cancer, improving survival outcomes.
Cirrus Therapeutics secures $11M seed funding to develop IRAK-M-targeted ocular gene therapy, aiming to prevent and reverse vision loss in dry age-related macular degeneration.
Health Canada approves AGAMREE (vamorolone) for treating Duchenne muscular dystrophy in patients aged 4+, marking the first authorized therapy for DMD in Canada.
Dr. Claudia Süssmuth Dyckerhoff will not seek re-election to Roche’s Board of Directors at the 2026 AGM, concluding a decade of valuable contributions to the company.
Jazz Pharma’s Zepzelca + Tecentriq combo wins FDA approval as the first maintenance therapy for ES-SCLC, showing strong survival benefits in Phase 3 trial.
Corvus Pharmaceuticals appoints Novo Nordisk EVP David Moore to its Board of Directors, bringing deep expertise in pharmaceuticals, biotechnology, and immunotherapy innovation.
Perspective Therapeutics begins second cohort dosing in Phase 1/2a trial of [212Pb]PSV359, a targeted alpha radiopharmaceutical for FAP-α solid tumors.
Astria Therapeutics opens EU sites for the Phase 3 ALPHA-ORBIT trial of navenibart, a potential long-acting treatment for hereditary angioedema (HAE).
Immunotherapeutics appoints Marc Le Bozec interim CEO as Nicolas Poirier steps down; search for a permanent CEO is underway
Roche gets CE mark for AI Kidney Klinrisk Tool, offering a CKD algorithm panel for early detection and management of chronic kidney disease.
Harness Therapeutics launches MISBA® Duo platform, partnering with Ono Venture Investment to develop dual-target therapies for neurodegenerative diseases.
Trogenix secures £70M Series A to accelerate clinical development of potentially curative therapies for aggressive solid tumours using its Odysseus® platform.
Plasmagen Biosciences names Vivek V Kamath as CEO to lead growth of its plasma-derived biopharma business.
Lonza expands TheraPEAK range with new cytokines and 293-GT medium to boost cell and gene therapy manufacturing.
PL-14 limits allergen penetration, forming a nasal barrier and showing promising preclinical results for allergy prevention.
Eccogene secures FDA clearance for MOSAIC Phase 2a trial evaluating ECC4703 and ECC0509 for MASH treatment.
Phathom Pharmaceuticals appoints Sanjeev Narula as CFO to drive financial growth and strategic expansion.
FDA clears Invivyd’s IND for VYD2311, advancing its pivotal COVID-19 antibody program as a vaccine alternative.
Hervé Hoppenot joins Maze Therapeutics as Chairman, bringing 30+ years of biotech leadership to guide growth and advance kidney and metabolic disease therapies.
Qualigen Therapeutics appoints new executives and board members, enhancing governance and positioning for long-term growth.
AstraZeneca and Daiichi Sankyo’s Datroway significantly improved OS and PFS versus chemotherapy in the Phase III TROPION-Breast02 trial for TNBC.
AbbVie reports positive Phase 2 ELATE trial results for BOTOX® in upper limb essential tremor, meeting primary and secondary endpoints.
Marker Therapeutics treats first patient in its off-the-shelf MAR-T cell program, reporting encouraging safety results from the Phase 1 RAPID trial.
Merck launches three Phase 2b trials for tulisokibart (MK-7240) in hidradenitis suppurativa, axial spondyloarthritis, and rheumatoid arthritis.
EMA accepts Alvotech and Advanz Pharma’s MAA for AVT23, a proposed biosimilar to Xolair® (omalizumab), advancing global access to allergy and asthma therapies.
Alembic and Amlan launch MinerTox-Z and MinerTox-A in India to protect poultry from toxins and boost farm productivity.
Theolytics names Dr. Matilde Saggese as Chief Medical Officer to lead clinical development of THEO-260 and strengthen oncolytic immunotherapy leadership.
Qualigen Therapeutics appoints new Co-CEO, CFO, and Board members to strengthen leadership, enhance oversight, and drive strategic growth.
CervoMed names Matthew Winton, Ph.D., Chief Commercial & Business Officer to lead late-stage development and commercialization of neflamapimod for DLB.
Jade Biosciences launches JADE201, a half-life extended anti-BAFF-R antibody designed to deliver lasting efficacy in treating autoimmune disorders.
Relmada Therapeutics appoints Dr. Max Kates to its Clinical Advisory Board to support the development of NDV-01 for urologic oncology patients.
Bioxodes names industry leader Philippe Monteyne as Chairman to guide late-stage development of its breakthrough stroke therapy, BIOX-101.
Eli Lilly’s Omvoh (mirikizumab) becomes the first IL-23p19 inhibitor to sustain long-term remission through four years in ulcerative colitis patients.
Oragenics collaborates with Receptor.AI to utilize AI-driven receptor modeling, aiming to expand its brain-targeted therapeutics portfolio for neurological conditions.
Merck completes the $10 billion acquisition of Verona Pharma, gaining Ohtuvayre COPD therapy, to expand its cardiovascular and pulmonary pipeline.
Baxdrostat’s Phase III trial shows significant 24-hour systolic BP reduction in treatment-resistant hypertension with a consistent safety profile.
Hyderabad hosts analytica Lab India & Pharma Pro&Pack Expo 2025, uniting 650+ exhibitors and 32,000+ visitors in innovation.
Libtayo is now the first immunotherapy approved to prevent recurrence in high-risk CSCC after surgery and radiation.
Santhera partners with Biomedica to launch AGAMREE for Duchenne muscular dystrophy in Russia, expanding access for patients from Q1 2026.
Tessera Therapeutics receives $41.3M from ARPA-H to advance next-gen in vivo CAR-T therapies using Gene Writing and LNP delivery platforms.
Biomerica adds former LabCorp CEO Gary Huff to its board to drive growth, innovation, and expansion in advanced diagnostic solutions.
Ascendis Pharma seeks EMA approval for TransCon CNP to treat children with achondroplasia, backed by pivotal clinical data.
Children’s Hospital Colorado becomes newest center for ZEVASKYN gene therapy, providing FDA-approved treatment for RDEB patients of all ages.
FDA approves protocol amendment for Aardvark’s Phase 3 HERO trial, lowering age to 10 to evaluate ARD-101 in more patients with Prader-Willi Syndrome.
Charles River and Toxys announce collaboration to integrate ReproTracker®, an assay for developmental toxicity assessment in drug and chemical testing.
Astria Therapeutics launches Phase 3 ORBIT-EXPANSE trial of navenibart for hereditary angioedema, featuring flexible Q3M and Q6M dosing to enhance patient care.
Werewolf Therapeutics earns FDA Fast Track Designation for WTX-124, an IL-2 INDUKINE therapy for advanced or metastatic cutaneous melanoma post-immunotherapy.
Rigel starts Phase 1b dose expansion for R289, its IRAK1/4 dual inhibitor, in relapsed or refractory lower-risk MDS after completing dose escalation.
Thermo Fisher unveils MMDx Lung, a machine learning–based test that enhances biopsy accuracy and aids early detection of lung transplant rejection.
Gelteq teams with Melbourne Health to develop a gel-based HAMSB product aimed at reducing bowel polyp growth and lowering bowel cancer risk.
Akari Therapeutics expands its IP with two USPTO filings supporting its PH1 payload and next-gen immuno-oncology ADC therapies.
TELA Bio names Dr. Betty Jo Rocchio to its Board of Directors as Lisa Colleran steps down after five years of dedicated service.
Alex Kane joins Pyxis Oncology as Senior VP of Investor Relations & Capital Markets to strengthen capital strategy and investor engagement for ADC programs.
FDA grants Breakthrough Therapy designation to Cidara’s CD388 for preventing seasonal influenza in high-risk adults and adolescents.
Dr. Mark Hyman joins ADvantage Therapeutics to support Klothea Bio’s Klotho longevity programs and advance next-generation anti-aging therapies.
Shuttle Pharmaceuticals signs letter to acquire Molecule.ai, integrating its AI-powered drug discovery platform to accelerate therapeutic development.
Autonomix earns a new U.S. patent for its feedback-driven cardiac neuromodulation system, expanding precision treatment platform across major heart conditions.
Adial Pharmaceuticals completes analytical validation of its swab genetic test with Genomind, advancing AD04 toward FDA registration for Alcohol Use Disorder.
Acurx Pharmaceuticals earns Australian patent for DNA Polymerase IIIC inhibitors, expanding its global antibiotic IP protecting next-gen Gram-positive therapies.
Novo Nordisk will acquire Akero Therapeutics in a $4.7B deal, strengthening its metabolic disease pipeline with Phase 3 MASH candidate efruxifermin (EFX).
Kodo Life Sciences’ Dr. Ravish Patel shares leadership insights, Gen Z lessons, and the mindset behind pharma innovation.
Teva and Medincell’s UZEDY® (risperidone) wins FDA approval as a once-monthly injectable for maintaining treatment in adults with bipolar I disorder.
Bristol Myers Squibb to acquire Orbital Therapeutics for $1.5B, gaining an AI-driven RNA platform and an in vivo CAR T-cell therapy candidate, OTX-201.
Elutia adds healthcare veteran Guido J. Neels to its Board and audit committee, bringing 40+ years of leadership from Guidant, EW Healthcare, and Eli Lilly.
AstraZeneca strikes a historic deal with the Trump administration to lower U.S. drug prices, expand manufacturing, and invest $50B in American innovation.
AbbVie gains FDA approval to expand RINVOQ’s indication for adults with ulcerative colitis and Crohn’s disease, offering more treatment flexibility.
LEQEMBI IQLIK, Eisai and Biogen’s at-home Alzheimer’s treatment autoinjector, is named among TIME’s Best Inventions of 2025 in the healthcare category.
Palisade Bio gets Canadian patent for PALI-2108, a colon-targeted PDE4 inhibitor for Crohn’s disease and ulcerative colitis, valid through 2041.
Abeona’s ABO-503 for X-linked retinoschisis selected for FDA RDEA pilot, advancing rare disease endpoints and accelerating gene therapy development.
Ardelyx names Sue Hohenleitner as CFO to drive strategic financial growth, leveraging 30+ years of industry experience in finance and operations.
Soleno Therapeutics adds Mark W. Hahn to its Board to strengthen strategic leadership and support the commercial growth of VYKAT™ XR for rare diseases.
Hinge Bio’s HB2198, a first-in-class B cell-depleting therapy for SLE and Lupus Nephritis, receives FDA IND clearance to start clinical trials.
BioCryst acquires Astria Therapeutics for $700M, adding late-stage HAE drug navenibart and strengthening its rare disease treatment pipeline.
Rocket Pharmaceuticals’ BLA resubmission for KRESLADI™, a gene therapy for severe LAD-I, accepted by FDA; PDUFA date set for March 28, 2026.
Celularity’s Phase 2 trial shows PDA-002 significantly improves healing in diabetic foot ulcers with PAD, offering a safe, regenerative treatment option.
Globus Medical unveils the ANTHEM™ Elbow Fracture System, anatomically contoured plates with polyaxial locking to simplify complex elbow fracture surgeries.
SpyGlass Pharma’s BIM-IOL System demonstrates a 42% reduction in IOP and complete independence from eye drops at 24 months, offering hope for glaucoma patients.
Cabaletta Bio names Steve Gavel as Chief Commercial Officer to drive global commercialization of rese-cel and future autoimmune therapy programs.
Arthur Golden joins Turn Therapeutics’ Board to enhance governance and support strategic growth in dermatology, wound care, and infectious disease programs.
James Rawls joins LB Pharmaceuticals as SVP of Regulatory Affairs to advance LB-102 trials for schizophrenia and bipolar depression.
Candel Therapeutics raises $130M term loan to fund CAN-2409 Phase 3 trials, clinical development, and growth initiatives in prostate cancer and NSCLC.
Robert J. Dempsey appointed Interim CEO at Ashvattha to advance migaldendranib after positive Phase 2 results and FDA guidance on pivotal trials.
Kamal Adawi joins Fate Therapeutics as CFO to drive corporate strategy and support clinical development of iPSC-derived cellular therapies.
Sheikh Dr. Khalid Al Thani joins BPGbio to guide global oncology, AI-driven programs, and strategic corporate development.
FDA grants platform technology status to Krystal Biotech’s HSV-1 vector, supporting KB801 development for neurotrophic keratitis treatment.
Quercis Pharma and founder Thomas Lines are nominated for the 2025 Prix Galien USA “Best Startup” award, honoring innovation in biopharma.
Novartis’ Fabhalta® meets Phase III endpoint, showing slowed kidney function decline in adults with IgA nephropathy (IgAN).
Belite Bio’s Tinlarebant receives China NMPA priority review for Stargardt disease based on positive interim Phase 3 DRAGON trial results.
Taysha Gene Therapies regains full global rights to TSHA-102 for Rett syndrome, following Astellas agreement expiry, advancing toward pivotal REVEAL trial.
Galapagos NV appoints Fred Blakeslee as Executive VP and General Counsel to enhance its global legal and corporate strategy during its transformation.
Candel Therapeutics appoints Dr. Bali Pulendran, a leading systems immunology expert, to its Research Advisory Board to advance CAN-2409 and CAN-3110 programs.
Merck reports positive final results from its KEYNOTE-B96 trial, showing improved survival for ovarian cancer patients treated with KEYTRUDA-based therapy.
Praxis Precision Medicines announces successful Phase 3 Essential3 trial results for ulixacaltamide, showing strong efficacy and durability in essential tremor.
Thermo Fisher Scientific partners with OpenAI to integrate AI across research, clinical trials, and operations, accelerating drug development and boosting innovation.
Aligos Therapeutics announces the USAN Council has adopted “pevifoscorvir sodium” as the official generic name for its investigational HBV therapy, ALG-000184.
Genentech introduces its first Direct-to-Patient program for Xofluza, offering $50 flu treatment, home delivery, and expanded savings to improve U.S. patient access.
Disc Medicine secures FDA Commissioner’s National Priority Voucher for bitopertin, a potential new therapy for erythropoietic and X-linked protoporphyria (EPP/XLP).
AstraZeneca and Amgen’s Tezspire was approved by the FDA for CRSwNP, the first TSLP-targeting biologic for adults and adolescents with uncontrolled nasal polyps.
Novartis’ Scemblix receives a positive CHMP opinion for EU approval in all lines of Ph+ CML-CP, showing superior efficacy compared to other TKIs in trials.
Oryzon Genomics received FDA feedback on its Phase III vafidemstat BPD trial, plans to revise and resubmit protocol; other CNS programs continue as scheduled.
AstraZeneca’s Saphnelo wins CHMP backing for EU approval as a once-weekly self-injectable treatment for systemic lupus erythematosus, expanding patient access.
SystImmune and Bristol Myers Squibb’s bispecific ADC iza-bren shows promising antitumor activity and manageable safety in global Phase I NSCLC study.
AbbVie completes acquisition of Gilgamesh’s bretisilocin, a next-gen short-acting 5-HT2A agonist in Phase 2 trials for major depressive disorder.
AstraZeneca’s Imfinzi plus BCG therapy cut the risk of recurrence or death by 32% in BCG-naïve, high-risk NMIBC patients, per Phase III POTOMAC results.
Valitor appoints biotech and ophthalmic veteran Gregory D. Kunst as CEO to advance next-gen eye therapies and clinical programs.
Roche’s evERA trial shows giredestrant plus everolimus boosts PFS by 44% in ITT and 62% in ESR1-mutated ER+ advanced breast cancer.
Novartis Kisqali® shows 28% lower recurrence risk in high-risk early breast cancer in 5-year NATALEE trial.
FDA awards Achieve Life Sciences a priority voucher for cytisinicline, supporting nicotine e-cigarette and vaping cessation.
Katina Dorton joins Prelude Therapeutics’ Board, bringing 30+ years of healthcare and finance expertise to advance the precision oncology pipeline.
FDA grants Orphan Drug Designation to Kiniksa’s KPL-387 for pericarditis, supporting development of a monthly self-injection therapy; Phase 2/3 data expected H2 2026.
CHMP gives positive opinion for PYRUKYND® (mitapivat) to treat anemia in adults with alpha- or beta-thalassemia, pending EU approval.
India’s biggest life sciences pitch stage returns Nov 14 at ISB Hyderabad with $5M capital, investor access & biomanufacturing scale-up support.
Pharma leaders convened at PM&AC 2025, Hyderabad, to spotlight digital transformation, sustainability, AI, and award industry trailblazers.
PM&AE Awards 2025 recognized India’s top pharma companies and leaders for innovation, sustainability, automation, and visionary manufacturing.
Novartis to buy Avidity Biosciences for $12B, adding AOC RNA tech and late-stage neuromuscular programs to boost its neuroscience pipeline.
Kura Oncology earns $30M from Kyowa Kirin as Phase 3 KOMET-017 trials begin for ziftomenib, a menin inhibitor targeting AML treatment.
Health Canada approves LEQEMBI, the first treatment targeting Alzheimer’s cause, slowing cognitive decline in early-stage patients.
Syndax gains FDA approval for Revuforj to treat relapsed or refractory NPM1-mutated AML in adults and children, expanding its leukemia therapy reach.
Medera begins Phase 2 of the MUSIC-HFrEF trial, dosing the first patient with SRD-001 gene therapy for heart failure with reduced ejection fraction.
Clearmind Medicine appoints Mary-Elizabeth Gifford as Chief of Global Impact to lead U.S. partnerships, advocacy, and ethical advancement in psychedelic medicine.
Immatics appoints Amie Krause as Chief People Officer to lead HR strategy and drive growth as the company transitions to a commercial-stage enterprise.
Cellectar receives FDA Rare Pediatric Disease Designation for iopofosine I-131, advancing its mission to treat pediatric high-grade glioma brain cancer.
Evaxion appoints Dr. Helen Tayton-Martin as CEO to lead growth, leveraging her biotech expertise and leadership to advance AI-Immunology™-powered vaccines.
Biomea Fusion begins Phase I trial of BMF-650, its next-gen oral GLP-1 receptor agonist for obesity, after strong preclinical results showing significant weight loss.
Cocrystal Pharma secures a $500K SBIR Phase I grant from NIH/NIAID to develop an oral broad-spectrum antiviral targeting the influenza polymerase complex.
FDA expands Merck’s WINREVAIR approval to include reduced risk of death, hospitalization, and transplant in pulmonary arterial hypertension patients.
BridgeBio’s BBP-418 delivers positive Phase 3 results in limb-girdle muscular dystrophy, showing strong safety, with an FDA filing planned for 2026.
Artelo Biosciences appoints Mark Spring as Chief Financial Officer, strengthening its financial leadership, advancing its clinical pipeline and growth plans.
RAPT Therapeutics begins its Phase 2b prestIgE trial evaluating ozureprubart for IgE-mediated food allergies to assess efficacy and safety.
Amneal introduces Brekiya, the first ready-to-use DHE autoinjector for acute migraine and cluster headaches in adults, now available via specialty pharmacies.
Step Pharma names Dr. Karen L. Smith as CMO to advance CTPS1 inhibitor dencatistat in cancer and blood disorder treatment.
ORYZON names Dr. Iman Barilero as Senior Advisor for Regulatory Affairs to strengthen global strategy and support Phase III trials of vafidemstat in BPD.
AC Immune names Dr. Catherine Mummery as Chair of its Clinical Advisory Board to guide clinical strategy and advance neurodegenerative drug development.
CervoMed names David Quigley to its Board of Directors to guide growth and Phase 3 plans for neflamapimod in dementia with Lewy bodies.
Palisade Bio names Sharon Skare, PhD(c), as VP, Global Head of Clinical Operations to advance PALI-2108 and strengthen its precision therapy pipeline.
Roche’s Elecsys® Dengue Ag test earns CE mark, enabling early and accurate dengue diagnosis amid record global infections.
The EU has approved Alexion’s Koselugo for adults with NF1 and inoperable plexiform neurofibromas, backed by strong Phase III KOMET trial results.
Merck and Eisai’s WELIREG + LENVIMA combo significantly improves PFS and ORR in advanced RCC, showing promise beyond current anti-PD-1/L1 therapies.
Merck’s KEYTRUDA + WELIREG combination shows significant disease-free survival benefit in Phase 3 adjuvant RCC trial, a key milestone in kidney cancer care.
Novartis finalizes its $48-per-share acquisition of Tourmaline Bio, delisting it from Nasdaq and making it an indirect wholly owned subsidiary.
Jazz Pharmaceuticals adds Dr. Ted Love, former GBT CEO, to its Board effective Dec 1, 2025, as long-time member Kenneth O’Keefe announces retirement.
PDS Biotech requests FDA meeting for expedited approval of PDS0101 after strong VERSATILE-002 results in HPV16-positive head and neck cancer.
Avalo Therapeutics completes Phase 2 LOTUS trial enrollment for AVTX-009 in hidradenitis suppurativa; topline results expected by mid-2026.
Dewpoint Therapeutics receives FDA Orphan Drug Designation for DPTX3186, a novel condensate modulator targeting gastric cancer, with trials set for 2025.
AnaptysBio reports durable efficacy and strong safety for rosnilimab in Phase 2b rheumatoid arthritis trial at ACR 2025.
Amneal receives FDA tentative approval for its first MDI inhaler, the generic version of QVAR, expanding its portfolio into complex respiratory therapies.
RemeGen’s Phase 3 gMG trial shows telitacicept sustained 48-week efficacy and favorable safety, with high MG-ADL and QMG improvement rates across patients.
FDA grants Priority Review to BioMarin’s PALYNZIQ sBLA to include adolescents aged 12–17 with PKU; EU submission to follow based on PEGASUS Phase 3 data.
AbbVie’s Phase 3 trials show RINVOQ (upadacitinib) met key endpoints in adults and adolescents with non-segmental vitiligo, with no new safety concerns.
Skillup To Scaleup opens a new academy in Ahmedabad to train 10 million pharma professionals by 2030.
Medicus partners with the Gorlin Syndrome Alliance to expand FDA compassionate access to SKINJECT™, its investigational microneedle therapy for BCC.
Novartis’ ianalumab met key endpoints in Phase III trials for Sjögren’s disease, showing sustained ESSDAI improvements and favorable safety versus placebo.
Elixir Software’s CEO Dr. Paul Faulder reveals how iTraX unifies pharma R&D teams, streamlines workflows, and accelerates discovery.
Akari Therapeutics appoints Dr. Sara Hurvitz to its new Scientific Advisory Board, strengthening its next-generation oncology ADC pipeline.
Alethio Therapeutics debuts with new leadership to develop two targeted ADC medicines for myeloproliferative neoplasms, chronic blood cancers.
Ritedose wins FDA approval to make Generic Tobramycin Inhalation Solution, becoming the U.S. leader with the largest nebulized drug portfolio.
Cartesian Therapeutics appoints Carsten Brunn, Ph.D., as Chairman, succeeding Carrie S. Cox, to strengthen leadership and advance cell therapy programs.
Arcutis launches FDA-approved ZORYVE® (roflumilast) cream 0.05% for children aged 2–5 with mild to moderate atopic dermatitis in the U.S.
Clearmind Medicine completes first cohort in its FDA-approved Phase I/IIa trial of CMND-100, a psychedelic-derived therapy for Alcohol Use Disorder.
Gefurulimab achieved statistically significant improvements in MG-ADL and QMG scores in the Phase III PREVAIL trial for AChR antibody-positive generalized MG.
Kiora joins Global Genes’ RARE-X Vision Consortium to accelerate research and improve clinical trial design for patients with rare ocular disorders.
Neuronetics signs a three-year exclusive deal with Elite DNA Behavioral Health to supply TMS devices and expand patient-support services across Florida.
Celularity forms a strategic partnership with DefEYE, securing exclusive rights and manufacturing roles for ophthalmic biologics following a $12M investment.
Foghorn Therapeutics reports progress in its ARID1B, CBP, and EP300 degrader programs, targeting key cancer mutations, moving toward proof of concept by 2026.
Lonza to acquire Redberry and its Red One™ platform, expanding rapid sterility and bioburden testing capabilities for pharma QC.
Kyowa Kirin International appoints Julie Dehaene-Puype as President for the International Region, succeeding Jeremy Morgan, supporting the company’s growth.
Oryzon Genomics enrolls first patient in RESTORE, a Phase Ib trial of iadademstat in sickle cell disease, evaluating safety, tolerability, and HbF induction.
Roche’s Phase III ALLEGORY study shows Gazyva achieved significant improvements in systemic lupus erythematosus, meeting all endpoints.
FDA issues a Complete Response Letter for Alvotech’s AVT05, a Simponi biosimilar; company lowers 2025 revenue and EBITDA guidance amid facility updates.
Merck Foundation launches $22M initiative to expand access to high-quality, equitable cardiac care across U.S. communities.
Benitec Biopharma appoints Dr. Sharon Mates to its Board, strengthening leadership as it advances its gene therapy programs.
Benitec’s BB-301 shows 100% response in OPMD trial, earning FDA Fast Track for its gene therapy targeting dysphagia.
Takeda’s QDENGA shows sustained 7-year protection and strong safety in Phase 3 dengue trial, supporting global immunization efforts.
Achieve Life Sciences reports final ORCA-OL trial results and FDA safety update, advancing cytisinicline toward approval for smoking cessation.
Abivax reports positive Phase 3 PRO results for obefazimod, showing quality-of-life benefits in ulcerative colitis patients.
Kailera Therapeutics adds industry veteran Frank K. Clyburn, Jr. to its Board of Directors, strengthening leadership as it advances its obesity treatment portfolio.
Life Biosciences appoints David Guyer, M.D., to its Board, enhancing leadership in cellular rejuvenation and age-related disease research.
Vor Bio names Dr. Jeremy Sokolove as Chief Medical Officer to lead clinical development and advance therapies for autoimmune diseases.
Rein Therapeutics gains FDA clearance to resume its Phase 2 RENEW trial of LTI-03 for idiopathic pulmonary fibrosis, advancing its fibrosis therapy program.
Ardena names Dipesh Patel as Chief Quality Officer and Peter Rose as Chief Information Officer, reinforcing its focus on quality and digital integration.
Sandoz to acquire JEB SAS from Evotec SE, gaining biosimilar manufacturing tech and advancing its USD 300B market strategy.
Ratio Therapeutics names Dr. Marcel Reichen as Chief Strategy Officer to enhance radiopharmaceutical innovation and strategic growth.
ARS Pharma launches “Get neffy on Us” to offer free virtual visits and $0 co-pay access for its needle-free allergy treatment, neffy.
Phathom begins a Phase 2 study of VOQUEZNA for treating eosinophilic esophagitis, aiming to expand GI treatment options.
Praxis secures FDA alignment on relutrigine study for SCN2A and SCN8A epilepsies, paving the way for a potential NDA in early 2026.
Prelude collaborates with Incyte on JAK2 program, advances KAT6A degrader, and pauses SMARCA2 projects to extend cash runway into 2027.
Valneva’s VLA1601 Zika vaccine shows strong immune response and safety in Phase 1, outperforming first-generation candidate.
Merck ends its co-development deal with Falk, gaining full global rights to MK-8690 and recording a $150 million R&D charge.
Merck receives $700 million from Blackstone to fund Phase 3 trials of sacituzumab tirumotecan targeting TROP2 across multiple cancers.
Tonix partners with MGH for a Phase 2 trial of TNX-1500 to prevent kidney transplant rejection with fewer immunosuppressive side effects.
Prelude partners with Incyte for its selective JAK2V617F inhibitor program targeting myeloproliferative neoplasms with potential for disease modification.
Novo Nordisk’s STEP UP trial reveals Wegovy® helps patients achieve obesity and heart health goals, cutting risks beyond weight reduction.
Rhythm Pharmaceuticals secures public coverage for IMCIVREE across major Canadian provinces, improving access for Bardet-Biedl syndrome patients with obesity.
Design Therapeutics progresses GeneTAC® candidates DM1, FA, and FECD, with clinical milestones set for 2026 and a new board addition strengthening leadership
Marker Therapeutics appoints biotech leader Kathryn Penkus Corzo to its Board, reinforcing its mission to advance MAR-T cell therapies for cancer.
Charles River Laboratories’ strategic review leads to focused growth investments, divestitures, $295M in savings, and a new $1B stock repurchase program.
Jaya Biosciences secures a U.S. patent for methods to treat neurological diseases, including Alzheimer’s, strengthening its global gene therapy IP portfolio.
Clearmind files a new patent in South Korea for MEAI, a non-hallucinogenic compound for depression, strengthening its global neuroplastogen IP portfolio.
Jupiter Neurosciences receives FDA clearance to start a Phase 2a trial of JOTROL™ for Parkinson’s disease, marking a key milestone in its clinical development.
Normunity begins Phase 1 trial of NRM-823, a novel T cell engager targeting tumor-specific antigens in solid tumors, marking its move to a clinical-stage company.
Turn Therapeutics names Andrew Scott as VP of Corporate Communications to lead investor relations, capital markets, and growth strategy initiatives
Averoa gains UK MHRA approval for XOANACYL, a dual-action oral therapy for CKD complications.
Astria Therapeutics’ navenibart delivers robust HAE attack prevention and favorable safety in ALPHA-STAR trial, with all patients joining the long-term study.
ORIC Pharmaceuticals reports in Cancer Research that enozertinib, a selective EGFR exon 20 inhibitor, achieves complete systemic and brain responses in NSCLC.
Cue Biopharma partners ImmunoScape to develop a Seed-and-Boost in vivo T cell therapy for solid tumors, combining Immuno-STAT and proprietary TCR platforms.
Alvotech and Advanz Pharma gain UK MHRA approval for Gobivaz®, a biosimilar of Simponi® (golimumab), for treating multiple immune-mediated diseases.
Novo Nordisk’s CagriSema shows major blood pressure and inflammation reduction in obesity trial, suggesting added heart health benefits beyond weight loss.
Coherus Oncology names Arvind Sood Chief Strategy & Corporate Affairs Officer to drive partnerships and strengthen its oncology growth strategy.
Nasus Pharma receives Health Canada approval to begin a Phase 2 trial of NS002, its intranasal epinephrine powder for treating anaphylaxis and severe allergies.
Novo Nordisk reaches agreement with the U.S. Administration to cut prices and expand access to Wegovy® and Ozempic® under Medicare and Medicaid from 2026.
RenovoRx appoints UCLA pancreatic cancer expert Dr. Timothy Donahue to its Scientific Advisory Board to advance targeted therapies for hard-to-treat cancers.
Merck’s Phase 3 CORALreef HeFH trial shows enlicitide, an oral PCSK9 inhibitor, cut LDL-C by 59% at 24 weeks with strong one-year durability safety.
Baxdrostat met its Phase III endpoints, reducing 24-hour systolic BP by 14 mmHg in resistant hypertension and achieving strong efficacy and safety results.
Roche’s BTK inhibitor fenebrutinib met primary endpoints in RMS and PPMS Phase III trials, showing potent efficacy and consistent safety across both studies.
Vaxxas adds Brent MacGregor to its Board as it advances HD-MAP, a needle-free vaccine patch, toward commercialization and global vaccine accessibility.
Acumen Pharmaceuticals appoints biotech veteran George Golumbeski as Chairman to guide Alzheimer’s drug development and drive strategic growth.
Celldex names industry veteran Teri Lawver as SVP and CCO, succeeding Richard Wright, to lead commercialization and drive growth in immunology and inflammation.
HOPE Therapeutics introduces the one-day Ampa ONE-D TMS protocol in Florida, offering rapid, effective treatment for patients with resistant depression.
BioCardia and Henry Ford Health enroll first patient in Phase 3 CardiAMP HF II trial evaluating autologous cell therapy for ischemic heart failure.
Propanc Biopharma raises up to $100M from Hexstone Capital to accelerate proenzyme cancer therapy development and expand its digital asset portfolio.
Novartis inaugurates a 10,000-sq-ft RLT facility in Carlsbad, boosting U.S. cancer care capacity under its $23B investment plan to expand innovation.
AnaptysBio’s rosnilimab was safe but failed to meet efficacy goals in a Phase 2 ulcerative colitis trial, leading to its discontinuation and $10M of savings.
Transition Bio and Voyager Therapeutics form a partnership to develop TDP-43–targeting small molecules for ALS and FTD, with potential deal value up to $500M.
Reviva earns EU patent for brilaroxazine in pulmonary fibrosis, adding to U.S., China, and Japan, drug shows strong efficacy in CNS and inflammatory disorders.
MB-105 CAR-T receives FDA RMAT designation, accelerating development for relapsed or refractory CD5-positive T-cell lymphoma.
Ariceum starts Phase 1/2 trial of 225Ac-SSO110 for ES-SCLC and Merkel Cell Carcinoma, targeting aggressive neuroendocrine tumors.
Quoin Pharmaceuticals reaches 4% and 5% rapamycin concentrations in its topical and patch systems, advancing rare disease therapies.
BPGbio names John Dvor EVP to drive corporate growth, partnerships, and AI-driven biotech innovation.
Svan Analytical to showcase smart compliance, aseptic and analytical solutions at CPHI PMEC India 2025, Hall 15, Stall D32.
Novartis’ new antimalarial GanLum achieves 97.4% cure in Phase III study, offering first major malaria treatment breakthrough in 25 years.
Neuronetics’ NeuroStar TMS gains TRICARE coverage for adolescents aged 15+, expanding access to safe, effective depression therapy across 23 U.S. states.
Apellis reports five-year GALE study data showing SYFOVRE delayed lesion growth by ~1.5 years in geographic atrophy from AMD, confirming long-term efficacy.
Thermo Fisher’s EXENT System earns FDA 510(k) clearance, bringing automated, high-sensitivity testing to improve diagnosis of multiple myeloma.
Sarah Cannon Research Institute and Bristol Myers Squibb expand collaboration to speed oncology research and bring clinical trials closer to patients in U.S.
Cortland Biomedical implements key leadership changes to enhance operations, strengthen strategy, and support continued global business expansion.
LB Pharmaceuticals appoints Kaya Pai Panandiker as Chief Commercial Officer to lead commercial strategy, growth, and advance its neuropsychiatric pipeline.
BetaGlue Therapeutics gains MHRA approval to begin a clinical trial of YntraDose™ for unresectable locally advanced pancreatic cancer, advancing oncology innovation.
Velocity Clinical Research names Drew Reina as CRO to strengthen strategic partnerships, drive growth, and enhance collaboration with Sponsors and CROs.
Moleculin teams up with UNC-Chapel Hill for grant-funded research evaluating Annamycin as a potential new treatment for pancreatic cancer.
Immix Biopharma appoints Michael Grabow as CCO to lead the global launch of NXC-201, a potential first therapy for relapsed/refractory AL amyloidosis.
Longeveron secures a U.S. patent for using its stem cell therapy to treat aging-related frailty linked to inflammaging, extending protection through 2038.
FDA accepts Outlook Therapeutics’ resubmitted BLA for LYTENAVA™, setting a PDUFA date of December 31, 2025, advancing the wet AMD ophthalmic therapy.
Salarius and Decoy finalize their merger, forming Decoy Therapeutics to advance IMP3ACT-engineered peptide-conjugate antivirals and oncology candidates.
Legend Biotech launches a state-of-the-art 31,000-sq-ft R&D center in Philadelphia, strengthening its U.S. cell therapy footprint.
Amneal wins FDA approval for the first generic iohexol injection, expanding access to a key contrast agent used across imaging procedures starting in early2026
Eisai and Biogen secure MHRA approval for LEQEMBI’s once-every-four-weeks maintenance dosing, a long-term treatment option for early Alzheimer’s disease.
ORIC reports new Phase 1b data shows ORIC-944 plus AR inhibitors is well tolerated in heavily pretreated metastatic castration-resistant prostate cancer patients.
Medicus secures UK regulatory and ethical approvals to expand its Phase 2 trial of Doxorubicin Microneedle Array for non-invasive treatment of BCC
Bry-Air unveils the P80x dehumidifier with MOF rotor tech, delivering higher performance and major energy savings for pharma environments.
Biogen acquires Alcyone Therapeutics, adding ThecaFlex DRx™ to its CNS portfolio to improve intrathecal delivery and support future SPINRAZA use.
COSCIENS Biopharma appoints Peter Puccetti as Interim CEO after Anna Biehn’s exit, guiding cost reduction, operational focus, and strategic realignment.
Silo Pharma teams with Allucent to support FDA IND filing for SPC-15, an intranasal therapy targeting PTSD, with Phase 1 trials planned for 2026
Onco360 selected as pharmacy partner for Komzifti™, providing adult AML patients with NPM1 mutation access and support for this targeted therapy.
Dewpoint Therapeutics’ DPTX3186 receives FDA Fast Track for gastric cancer, aiming to speed development of this first-in-class condensate modulator therapy.
Apollomics expands its board with Dr. Ya-Chi (Claudia) Huang, strengthening audit and corporate governance committees.
Clearmind seeks Israeli patent for MEAI-PEA therapy, offering depression relief without hallucinogenic effects.
Johnson & Johnson will acquire Halda Therapeutics, advancing HLD-0915 for advanced prostate cancer, backed by promising Phase 1/2 data.
Akari Therapeutics names finance expert Kameel D. Farag as Interim CFO to support growth and advance its next-generation ADC development strategy.
Neurona Therapeutics appoints Dr. Eduardo Dunayevich as CMO to guide clinical strategy ahead of the pivotal Phase 3 EPIC study of NRTX-1001 for focal epilepsy.
Zymeworks appoints Scott Platshon as Acting CIO to oversee future cash flows from Ziihera and other licensed assets, strengthening its long-term growth strategy.
MediciNova names Dr. Christopher Breder as Clinical and Regulatory Advisor to strengthen its drug development strategy and advance neuroscience programs
Annovis schedules an FDA meeting for its PDD program and reconfirms FDA support for its Phase 3 Alzheimer’s trial, advancing buntanetap development.
FDA approves Genmab’s EPKINLY + R2 for relapsed or refractory follicular lymphoma, offering stronger responses and improved progression-free survival.
HCW Biologics doses the first patient in its Phase 1 trial of HCW9302, a Treg-activating IL-2 fusion therapy developed to treat alopecia areata.
Merck’s Phase 2 CADENCE trial shows WINREVAIR significantly reduces pulmonary vascular resistance in CpcPH due to HFpEF, with safety consistent with prior data.
Roche’s Positive lidERA Phase III Data Support Giredestrant as a Promising New Adjuvant Therapy for ER-Positive Breast Cancer
Thermo Fisher launches its Philadelphia ATxCC, expanding U.S. support for cell and gene therapy innovation with advanced labs and collaborative space.
AbbVie’s EPKINLY + R2 secures full FDA approval for R/Rfollicular lymphoma after strong Phase 3 results showing major gains in response and survival.
Tempest acquires dual-target CAR-T programs from Factor Bioscience expanding its oncology pipeline and extending its cash runway through mid-2027.
Novartis will build a flagship manufacturing hub in North Carolina, expanding biologics, sterile, and oral dosage production while creating thousands of jobs.
Regeneron’s EYLEA HD secures FDA approval for RVO, offering extended dosing options supported by QUASAR trial and ongoing updates to PFS manufacturing plans.
The EU approves Libtayo for high-risk CSCC, backed by Phase 3 data showing a 68% reduction in recurrence or death.
Elicio Therapeutics names Marc Wolfgang as CTO to strengthen CMC, manufacturing, and development ahead of key late-stage milestones.
EU approves subcutaneous Lunsumio for relapsed follicular lymphoma, offering faster one-minute dosing with strong efficacy and flexible treatment options.
Mesoblast and NIH BMT CTN begin a pivotal Phase 3 trial evaluating Ryoncil for adults with severe steroid-refractory aGvHD to improve survival outcomes.
Crinetics begins Phase 3 CAREFNDR trial evaluating once-daily paltusotine for carcinoid syndrome to improve symptom control and long-term outcomes.
Inhibikase Therapeutics advances IKT-001 into a global adaptive Phase 3 IMPROVE-PAH study to improve pulmonary vascular resistance and exercise capacity.
Nasus Pharma appoints Eyal Rubin as Executive Vice President and CFO to lead financial strategy and support clinical and commercial growth.
Evaxion reports new data showing protective effects of novel AI-discovered antigens in its multi-component CMV vaccine EVX-V1.
JetSpray to unveil advanced CIP systems at CPHI & PMEC India 2025, highlighting precision, audit-ready hygiene, and high-efficiency cleaning solutions for pharma.
CNSide Diagnostics signs national deal with Humana, expanding coverage of CNSide® CSF Tumor Cell Enumeration test to 67M people for leptomeningeal metastases care.
Novartis’ Itvisma becomes the first gene replacement therapy approved for SMA patients aged two to adulthood, offering sustained motor function improvement.
The European Commission approves Breyanzi for R/R mantle cell lymphoma, offering high response rates and durable benefit after BTK inhibitor therapy.
Plus Therapeutics progresses its REYOBIQ radiotherapy program after an FDA Type B meeting, addressing need for treatments for leptomeningeal metastases.
Biogen and Dayra Therapeutics team up to develop oral macrocyclic peptides to deliver biologic-like efficacy in immunology, backed by a $50M upfront payment.
Tonix secures FDA IND clearance to advance TNX-102 SL into a pivotal Phase 2 study for major depressive disorder, addressing need for better treatment options.
Novo Nordisk reports oral semaglutide failed to slow Alzheimer’s progression in phase 3 trials, despite biomarker improvements & consistent safety profile.
Tiziana Life Sciences’ Phase 2 nasal foralumab trial for ALS accepted into Healey ALS MyMatch Program, supported by ALS Association and NEALS Consortium.
Teva secures EU approval for PONLIMSI and DEGEVMA, its denosumab biosimilars to Prolia and Xgeva, expanding access to high-quality biologic therapies in Europe.
Clearmind Medicine begins enrolling patients at Tel Aviv Sourasky Medical Center in its Phase I/IIa CMND-100 trial for Alcohol Use Disorder.
Valneva’s VLA15 Lyme vaccine shows strong immune response and favorable safety six months after third booster, supporting annual vaccination potential.
FDA extends review of Ascendis’ TransCon CNP (navepegritide) for children with achondroplasia to Feb 28, 2026 after major NDA amendment.
LIXTE acquires Liora Technologies, adding the advanced LiGHT proton therapy system while progressing LB-100 clinical trials in a new cancer treatment paradigm.
Imfinzi plus FLOT chemotherapy wins US approval for resectable gastric and GEJ cancers after Phase III data show major gains in event-free and overall survival.
Eisai submits sBLA for LEQEMBI’s weekly subcutaneous autoinjector, aiming to offer Alzheimer’s patients an at-home alternative to IV dosing.
Novo Nordisk’s amycretin delivers strong HbA1c reductions and weight loss in phase 2 trials, supporting its move into phase 3 development for type 2 diabetes.
The EU has approved Dupixent for moderate-to-severe CSU in patients 12+, offering a new first-line targeted option for those unresponsive to antihistamines.
GENFIT appoints Dr. Pejvack Motlagh as Chief Medical Officer to lead clinical strategy and advance therapies for rare, life-threatening liver diseases.
Freya Pharma becomes Arletta Pharma, marking a major step toward innovative treatments for FSIAD and advancing women’s sexual health.
Dupixent secures EU approval as the first targeted therapy in 10 years for chronic spontaneous urticaria, offering improved relief for uncontrolled symptoms
Kiora Pharmaceuticals receives a new U.S. patent for novel KIO-104 formulations, expanding delivery options for KIO-104’s retinal inflammation therapy.
Regeneron and Tessera form a global partnership to develop TSRA-196, a gene-writing therapy targeting the genetic cause of alpha-1 antitrypsin deficiency.
Medicus Pharma names President Carolyn Bonner as its new CFO, adding financial leadership to her strategic role as the company advances clinical development.
Decoy Therapeutics and Texas Biomed join forces to test peptide fusion inhibitors against various influenza strains, developing of broad-spectrum antivirals.
The FDA approves Amneal’s generic version of RESTASIS®, a preservative-free cyclosporine 0.05% eye drop for dry eye patients, entering a $2B U.S. market.
COSCIENS signs a 10-year exclusive deal with Wuzhou for Macrilen distribution across Hong Kong, Macao, Singapore, Guangdong, and Hainan.
Mapi Pharma to present partnering opportunities and long-acting depot innovations at the 8th Evercore Healthcare Conference in Miami.
CLN-049 receives FDA Fast Track for relapsed/refractory AML; Phase 1 data to be presented at ASH Annual Meeting.
University of Bonn enrolls first patients in Biodexa’s Phase 3 Serenta trial evaluating eRapa for familial adenomatous polyposis.
Tinlarebant shows positive Phase 3 results in Stargardt disease, reducing retinal lesion growth and marking a historic treatment milestone.
Greg Di Russo joins Kriya Therapeutics as CMO to lead clinical strategy, medical affairs, and drug safety across its expanding gene therapy pipeline.
Propanc requests Spain foreign filing license for two patents on resistant cancer and fibrosis treatments via its Australian subsidiary.
Dogwood Therapeutics files new IP for synthetic Halneuron®, potentially extending exclusivity to 2045 as its Fast Track non-opioid pain therapy progresses.
Thermo Fisher boosts its Asian bioprocessing network with a new Hyderabad center and expanded hubs in Korea and Singapore, enhancing biologics innovation.
Amneal secures FDA approval for its generic albuterol inhalation aerosol, strengthening its growing respiratory portfolio following QVAR® generic approval.
DiagnoSearch Life Sciences marks 30 years of scientific innovation, global clinical research excellence, and commitment to quality and regulatory integrity.
Roche’s new point-of-care PCR test for pertussis gains FDA clearance, CLIA waiver, and CE IVDR certification, improving rapid diagnosis and early treatment.
AstraZeneca’s baxdrostat receives FDA Priority Review for hard-to-control hypertension, backed by Phase 2 results showing significant blood-pressure reductions.
Drs. Richard Colvin and John McHutchison join Comanche Biopharma to advance CBP-4888 for sFlt1-mediated preterm preeclampsia globally.
Dr. Carlos Quezada-Ruiz joins Alkeus Pharmaceuticals to lead Phase 3 development of gildeuretinol for Stargardt disease, advancing vision-preserving therapies
FDA grants Fast Track to Sangamo’s ST-503, an epigenetic regulator for intractable small fiber neuropathy pain, supporting accelerated development.
Dr. Mary Tagliaferri joins ADARx Pharmaceuticals’ board to support growth and advancement of its RNA therapeutics pipeline.
LOMECEL-B gains Canadian patent protection until 2037 for treating aging frailty and non-ischemic dilated cardiomyopathy.
Dr. James Izanec joins Palisade Bio to lead clinical development of PDE4 programs for inflammatory and fibrotic diseases.
Dr. Petra Kaufmann joins Ovid Therapeutics as CMO to lead clinical and regulatory strategy for CNS therapies, including OV329 and KCC2 activators.
Bristol Myers Squibb will enrol more ADEPT-2 patients after identifying site irregularities, advancing Cobenfy’s development for Alzheimer’s psychosis.
New research shows Artelo’s SBFI103 eases anxiety and depression behaviours, boosts endocannabinoid signalling, and preserves neurogenesis in stress models.
Sapu003’s IV formulation reduces everolimus GI exposure by up to 67-fold, improving tolerability while enhancing systemic delivery and antitumor potential.
NEJM publishes strong Phase 3 results for EMPAVELI, showing major improvements in proteinuria, kidney function, and C3 clearance in C3G and IC-MPGN patients.
Marvin Slosman joins BioCardia’s Board as Dr. Richard Krasno steps down after nine years, strengthening leadership for cardiovascular and pulmonary therapies.
Dr. Darshan Dalal joins Actithera as CMO to lead clinical strategy and advance FAP-targeting radioligand therapy into clinical trials.
Former FDA division director Dr. Lee S. Simon joins DIMERx to guide clinical development and regulatory strategy for DMX-101, a non-addictive analgesic candidate.
Breyanzi wins FDA approval for adults with relapsed or refractory MZL after two prior treatments, supported by strong TRANSCEND FL response and durability data.
Takeda closes its collaboration with Innovent, securing global rights to oncology assets IBI363 and IBI343 and investing US$1.2B to expand cancer portfolio.
Praxis announces early-stop EMBOLD success for relutrigine in SCN2A/SCN8A DEEs. FDA to review data soon, with NDA timing to be decided after the meeting.
Merck’s EXZOLT CATTLE-CA1 earns FDA conditional approval for treating New World screwworm and fever ticks, with U.S. availability expected in early 2026.
Praxis gains FDA alignment after a successful pre-NDA meeting; plans to submit its essential tremor therapy NDA in early 2026, addressing unmet medical need.
Sandoz completes the acquisition of JEB SAS, gaining the Toulouse site and continuous manufacturing tech to strengthen its global biosimilars strategy.
Regeneron reports strong Phase 1/2 results for Lynozyfic in newly diagnosed multiple myeloma, with rapid deep responses and manageable safety.
Pfizer’s Phase 3 BASIS study shows HYMPAVZI delivers a 93% reduction in bleeding and improves quality of life for hemophilia A and B patients with inhibitors.
Amit Munshi joins Arcutis Board as founder Bhaskar Chaudhuri retires after nine years, continuing as consultant to support company growth and strategy.
LEQEMBI® (lecanemab) now on China’s Commercial Insurance Innovative Drug List, expanding access for early Alzheimer’s patients starting Jan 2026.
Immutep licenses Efti to Dr. Reddy’s for development and sales outside North America, Europe, Japan, and Greater China, unlocking global cancer therapy access.
Abeona administers FDA-approved ZEVASKYN for RDEB at Stanford, marking the first commercial treatment for this rare and serious genetic skin disorder
Moleculin Biotech teams with Spain’s CIC biomaGUNE to launch preclinical studies of Annamycin for aggressive glioblastoma treatment.
FDA approves ZORYVE® 0.05% cream for mild to moderate atopic dermatitis in children aged 2–5, offering a safe, non-steroidal treatment option.
Roche’s cobas BV/CV assay earns CE Mark, enabling precise detection of bacterial vaginosis and candida vaginitis using a single streamlined test.
EU approves Gazyva/Gazyvaro plus MMF for active lupus nephritis, backed by strong REGENCY data showing superior renal response and disease control.
Praxis announces positive relutrigine and vormatrigine data showing rapid, durable seizure reduction with strong safety ahead of FDA discussions.
Three-year STARGLO results show Columvi plus GemOx significantly improves survival in R/R DLBCL, supporting its global guideline-recommended use.
Agios reports the FDA has not yet ruled on its mitapivat sNDA for thalassemia, with review ongoing as labeling and REMS materials are finalized.
Howard Liang steps down as Tessera’s President & CFO; Kathy Bergsteinsson appointed CFO to support Gene Writing™ platform growth.
Novo Nordisk acquires Akero for $4.7B, offering $54/share cash and $6/share CVR for EFX in MASH cirrhosis, expanding its liver disease pipeline.
Alejandro Weinstein becomes Pluri’s Chairman as the company raises $2.5M via private placement to support growth and cell-based technology initiatives.
Pharma Project & Portfolio Management Conference 2026 in Goa unites industry leaders to master strategy, governance, execution, and digital transformation.
The 5th Drug Safety Symposium 2026 returns to Dubai, uniting regulators and pharma leaders to advance pharmacovigilance and patient safety in the Middle East.
Remarkable Women Camaraderie 2026 & Awards debuts in Goa, celebrating women’s leadership, mentorship, entrepreneurship, and empowerment.
Han Lee and Martin Murphy join Century Therapeutics’ board to advance iPSC-derived cell therapy pipeline and strategic growth.
Irina Ishak joins Tonix to lead legal, governance, and compliance functions starting Dec 8, 2025
Idorsia’s innovative insomnia treatment wins inaugural Prix Galien Bridges Award for Best Biotechnology & Pharmaceutical Product.
Chugai establishes a U.S. partnering office in South San Francisco to boost global innovation, deepen academic and start-up collaborations.
Roche reports Phase III data showing giredestrant reduces risk by 30% in early ER+ breast cancer, with strong safety and distant recurrence benefits.
Kane Biotech’s revyve® Antimicrobial Wound Gel Spray receives Health Canada approval, offering a new option for managing burns, ulcers, and complex wounds.
Valneva’s Phase 2 pediatric trial shows strong one-year immunity and solid safety for the IXCHIQ® chikungunya vaccine, supporting advancement to Phase 3.
Phase 3 HER2CLIMB-05 shows TUKYSA significantly extends progression-free survival in first-line HER2+ metastatic breast cancer.
AJ1-11095 receives FDA Orphan Drug Designation for myelofibrosis, advancing new therapy options for patients with limited treatment alternatives.
Amneal’s dual-format epinephrine injection approved by FDA, supporting emergency treatment of anaphylaxis and septic shock nationwide.
VTP-1000 shows strong safety and dose-dependent effects in Phase 1 AVALON trial for celiac disease, advancing immune tolerance therapy development.
Aardvark begins Phase 3 HERO trial of ARD-101 for hyperphagia in Prader-Willi syndrome, starting with first patient dosed in Australia.
JASCAYD (nerandomilast) approved in China as first new therapy in 5+ years for adults with progressive pulmonary fibrosis, offering improved treatment options.
Telix collaborates with Varian to combine theranostics and external beam radiation, aiming to improve prostate cancer treatment and personalized care.
Professor Prashant Yadav appointed to lead Bio Usawa’s Global Access and Health Equity Advisory Board, advancing equitable access to medicines worldwide.
Centessa Pharmaceuticals names Mario Alberto Accardi as CEO effective January 2026. His leadership will drive the company’s orexin-focused neuroscience pipeline, including OX2R agonists for narcolepsy, idiopathic hypersomnia, and broader neurological disorders.
Kymera receives FDA Fast Track designation for KT-621, a first-in-class oral STAT6 degrader for moderate to severe atopic dermatitis.
Abeona Therapeutics designates UTMB as a new Qualified Treatment Center for ZEVASKYN, the FDA-approved autologous gene therapy for recessive dystrophic epidermolysis bullosa. The partnership expands patient access across Texas and the Gulf Coast and supports advanced care for individuals living with this severe genetic skin disorder.
MAIA Biotechnology has begun dosing patients in the THIO-104 Phase 3 pivotal trial evaluating ateganosine plus a checkpoint inhibitor for advanced NSCLC. The global study compares overall survival against standard chemotherapy and builds on promising earlier data, positioning ateganosine as a potential new standard of care.
OKYO Pharma released new Phase 2 findings showing that urcosimod not only reduces neuropathic corneal pain but also improves corneal nerve structure. Patients receiving 0.05% urcosimod demonstrated increases in nerve fiber count and length, supporting its promise as a first-in-class therapy for NCP.
DISCO Pharmaceuticals appointed Mark Manfredi, Ph.D., as CEO and closed a €36M seed financing round to accelerate its surfaceome-guided ADC programs for SCLC and MSS-CRC. The funding supports IND-enabling studies, pipeline expansion, and continued development of novel oncology therapeutics driven by DISCO’s proprietary discovery platform.
BrandManthan 2025 brings pharma marketing leaders together in Mumbai to explore patient-centric branding, AI, data-driven strategy, and brand excellence awards.
FDA accepts CUTX-101 NDA resubmission for Menkes disease, advancing pediatric treatment with a target action date of January 14, 2026.
InnoCare achieves Phase 2b success for orelabrutinib in lupus and gains China approval to start Phase 3 trial, advancing Zenas BioPharma’s autoimmune pipeline.
Abeona names Mohamad Tabrizi as Chief Business Officer to lead strategy, business development, and enhance operational efficiency.
PharmAla partners with UK manufacturer to produce ALA-002, advancing its novel MDMA therapy toward Phase 2 trials in 2026.
Belgium approves BetaGlue’s clinical trial for YntraDose in unresectable pancreatic cancer, following UK and Italy clearances.
Adaptive Biotechnologies signs two non-exclusive deals with Pfizer to advance T-cell receptor research and AI-driven drug discovery.
The FDA approves Enhertu with pertuzumab for first-line HER2-positive metastatic breast cancer based on strong Phase III DESTINY-Breast09 results.
Hikma Pharmaceuticals announces CEO Riad Mishlawi’s exit as Said Darwazah assumes CEO role with immediate effect.
Thermo Fisher introduces next-generation Gibco Bacto CD media to simplify E. coli bioprocessing and improve plasmid DNA and protein yields.
Medicus completes enrolment in a Phase 2 U.S. study of D-MNA microneedle therapy for nodular basal cell carcinoma, with topline data expected in 2026.
Glenmark secures exclusive rights to develop and commercialise Hansoh’s aumolertinib across key global markets for EGFR-mutated NSCLC.
The EU approves AstraZeneca’s Saphnelo for subcutaneous self-administration in SLE, supported by positive Phase III TULIP-SC data.
Tonix acquires global rights to TNX-4900, a Sigma-1 receptor antagonist showing durable analgesic effects in neuropathic pain models.
Monte Rosa reports durable PSA and RECIST responses with MRT-2359 plus enzalutamide in AR-mutant metastatic prostate cancer.
ImmunityBio reports long-term survival, progression control and cystectomy avoidance with ANKTIVA plus BCG in papillary NMIBC patients.
Clearmind Medicine completes patient enrollment for Phase I/IIa CMND-100 trial, advancing a novel oral therapy for Alcohol Use Disorder.
Brooke Story joins PolyPid as Board Chairman, bringing 25+ years of global surgical and infection prevention leadership to guide clinical and commercial growth.
Recludix Pharma receives FDA clearance to start Phase 1 testing of REX-8756, a novel oral STAT6 inhibitor for inflammatory diseases.
Cellectar partners with Ionetix to ensure Ac-225 and At-211 supply for targeted alpha therapy programs and future clinical development.
Beacon starts LANDSCAPE trial to evaluate bilateral safety of laru-zova gene therapy for X-linked retinitis pigmentosa patients.
Chugai Pharmaceutical is named to CDP’s Double A-List, recognizing strong climate and water stewardship and transparent environmental disclosure.
EV-304 trial shows PADCEV plus Keytruda significantly improves event-free and overall survival in muscle-invasive bladder cancer.
HUTCHMED announces global Phase I clinical development of HMPL-A251, a first-in-class antibody-targeted therapy for HER2-expressing cancers.
Moleculin Biotech reports positive early Phase 1 data for WP1066 in children with aggressive brain tumors, showing immune activation and safety.
Nuvectis Pharma begins a Phase 1b trial evaluating oral NXP900 in combination with osimertinib for patients with EGFR-mutated NSCLC.
Processa reports Phase 2 data showing NGC-Cap increases capecitabine metabolite exposure without added toxicity in breast cancer patients.
Structure Therapeutics initiates a first-in-human Phase 1 trial of ACCG-2671, an oral small molecule amylin receptor agonist for obesity.
Tiziana Life Sciences doses first patient in a Phase 2 study of intranasal foralumab for early Alzheimer’s disease.
Eli Lilly reports positive Phase 3 data showing oral GLP-1 orforglipron maintains weight loss after Wegovy or Zepbound therapy.
Nxera Pharma regains full rights to its GPR52 agonist schizophrenia program after Boehringer Ingelheim declines license option.
Novo Nordisk submits an FDA NDA for once-weekly CagriSema, a GLP-1 and amylin combination injectable for obesity and overweight.
Salarius Pharmaceuticals plans to rename as Decoy Therapeutics and adopt NASDAQ ticker DCOY following its recent merger.
Thermo Fisher enrolls the first patient in its PPD CorEvitas Alzheimer’s Disease Registry to generate global real-world evidence.
Takeda reports positive topline Phase 3 data for oral TYK2 inhibitor zasocitinib in adults with moderate-to-severe plaque psoriasis.
vTv Therapeutics submits a Phase 2 study protocol for cadisegliatin, an oral adjunct to insulin, to DOH Abu Dhabi.
Sangamo starts a rolling BLA submission to the FDA seeking accelerated approval of ST-920 gene therapy for adults with Fabry disease.
Biofrontera completes the transfer of FDA NDA and IND approvals for Ameluz and the RhodoLED Lamp Series, gaining full U.S. control.
Alvotech and Teva settle with Regeneron, setting a U.S. launch date for AVT06, a proposed biosimilar to Eylea, in late 2026.
Cartesian Therapeutics appoints Adrian Bot, MD, PhD, to its Board, strengthening leadership in cell and immune therapy development.
ErlySign completes a 1,000-patient clinical trial for India’s first salivary biomarker test for early oral cancer detection, targeting market launch by April 2026.
Mumbai Biocluster and ICT Mumbai announce Biologics X 3DCC Summit 2026, uniting biologics and 3D cell culture leaders to advance next-gen biopharma innovation.
Japan’s MHLW approves Dupixent to treat severe or refractory asthma in children aged 6 to 11 years, expanding its pediatric use.
Alvotech begins the European launch of Gobivaz, the world’s first biosimilar to Simponi, commercialized with Advanz Pharma.
Curium announces first patient doses of PYLCLARI in Poland, expanding access to advanced PSMA PET imaging for prostate cancer.
FDA approves Amneal and mAbxience BLAs for Boncresa and Oziltus, two denosumab biosimilars to Prolia and XGEVA.
FDA approves Novo Nordisk’s oral Wegovy pill, the first oral GLP-1 for weight loss and cardiovascular risk reduction.
FDA approves AQVESME, an oral PK activator, to treat anemia in adults with alpha- or beta-thalassemia, including TD and NTDT.
Akari Therapeutics starts GMP manufacturing of AKTX-101 with WuXi XDC to support IND-enabling work ahead of Phase 1 trials.
European Commission approves Wayrilz, a novel oral BTK inhibitor, for adult patients with refractory immune thrombocytopenia.
Dyne Therapeutics names rare disease commercial leader Vikram Karnani to its Board as the company advances toward commercialization.
Pelthos Therapeutics names finance veteran Andrew Einhorn to its Board, strengthening capital markets and governance expertise.
Vor Biopharma appoints Andrew Levin of RA Capital and Wouter Joustra of Forbion to its Board following a $150 million PIPE financing.
Sanofi will acquire Dynavax for $2.2B, adding HEPLISAV-B and a shingles vaccine candidate to expand its adult immunization portfolio.
FDA issues a complete response letter for Sanofi’s tolebrutinib NDA for non-relapsing secondary progressive multiple sclerosis.
China’s NMPA approves neffy 2 mg, an epinephrine nasal spray, for emergency treatment of allergic reactions including anaphylaxis.
China’s NMPA accepts and grants priority review to HUTCHMED’s NDA for fanregratinib in FGFR2-positive ICC.
FDA grants Breakthrough Therapy Designation to ulixacaltamide for essential tremor, supporting accelerated development and review.
SELLAS reports an update on its Phase 3 REGAL trial evaluating GPS as maintenance therapy in AML patients in second remission.
Theriva receives EMA CHMP scientific advice supporting a Phase 3 trial design for VCN-01 in metastatic pancreatic cancer
Genelux names Jason Litten, MD, as Chief Medical Officer to lead clinical development as Olvi-Vec advances toward key milestones.
HUTCHMED begins the Phase III stage of its Phase II/III trial evaluating a four-drug combination as first-line therapy for metastatic PDAC.
ELMACH highlights the WKH-100 intermittent motion cartoner, offering flexible, GMP-compliant cartoning for pharma and cosmetics.
Biodexa Pharmaceuticals appoints Fiona Sharp as Chief Financial Officer and Company Secretary, and elects her to the Board.
ElevateBio names biopharma veteran Christopher Murphy as CEO and Board member to lead the company’s next growth phase.
Kriya Therapeutics names Sachiyo Minegishi as Chief Financial Officer to support corporate strategy and gene therapy commercialization plans.
OKYO Pharma names ophthalmology veteran Robert Dempsey as CEO, as Gary Jacob transitions to Chief Development Officer.
Tango Therapeutics names finance leader Sung Lee to its Board as the company advances vopimetostat into registrational studies.
Discover drug safety symposium Dubai highlights expert sessions and pharmacovigilance insights shaping patient safety regulatory and risk management trends in the pharma industry.
Explore highlights from Remarkable Women Awards 2026 celebrating pharmaceutical leadership innovation empowerment and women changemakers shaping the industry future.
Explore highlights from Remarkable Women Goa 2026 Awards celebrating leadership empowerment networking and recognition of women shaping change across industries and communities.
Atsena Therapeutics names McDavid Stilwell CFO to support gene therapy development and its LIGHTHOUSE trial for inherited retinal disease.
Galecto names Sherwin Sattarzadeh COO and Dr. Becker Hewes CMO to advance its pipeline toward clinical trials.
Remix Therapeutics names Mythili Koneru, MD, PhD, as CMO to lead clinical development of its RNA-targeting pipeline.
Sparrow Pharmaceuticals enrolls first patient in the Phase 2b CAPTAIN-T2D trial evaluating clofutriben in difficult-to-control type 2 diabetes.
SpyGlass Pharma names Jean-Frédéric Viret CFO to support late-stage development and commercialization of its BIM-IOL System.
Ascentage Pharma receives FDA IND clearance for APG-3288, enabling Phase 1 trials in relapsed or refractory B-cell malignancies.
Jazz Pharmaceuticals reports positive Phase 3 HERIZON-GEA-01 results for Ziihera, showing significant PFS and OS benefit in HER2+ GEA.
Outlook Therapeutics names Laura Cantrell VP of Corporate Strategy and Business Development to support long-term growth initiatives.
EMA accepts Milestone Pharma’s MAA for etripamil nasal spray, a self-administered treatment for paroxysmal SVT.
Thermo Fisher enrolls first patient in the PPD CorEvitas Obesity Registry to generate real-world evidence on obesity management.
Jasper Therapeutics names Jeet Mahal as President and CEO as it prepares to advance briquilimab into registrational trials for CSU.
Onco360 is named a limited distribution specialty pharmacy partner for Rigel’s TAVALISSE, GAVRETO, and REZLIDHIA.
FDA clears IND for Ottimo Pharma’s OTP-01, with first patient dosed in Phase I/IIA solid tumor study.
Crohn’s & Colitis Foundation approves up to $500K equity investment in Palisade Bio to advance PALI-2108.
Sanara MedTech’s BIASURGE solution secures a Vizient Innovative Technology contract, expanding access across U.S. hospitals.
Turn Therapeutics adds life sciences veteran Martin Dewhurst to its Board to support M&A-driven growth strategy.
Vaxxas names former Merck Global Vaccines President David Peacock as CEO to lead HD-MAP vaccine commercialization.
Syndax partners with WODA to expand international patient access to Revuforj through a global Managed Access Program.
Monte Rosa shares positive interim Phase 1 data for MRT-8102, showing strong inflammation reduction and favorable safety.
Merck launches Phase 3 KANDLELIT-007 trial evaluating calderasib plus KEYTRUDA QLEX in KRAS G12C-mutant NSCLC.
Merck completes its cash tender offer to acquire Cidara Therapeutics, strengthening its respiratory pipeline with CD388.
AstraZeneca names Joris Silon as Head of Investor Relations, effective March 2026, succeeding Andy Barnett and strengthening global investor engagement.
Amylyx names AMX0318, a long-acting GLP-1 receptor antagonist, as a development candidate for post-bariatric hypoglycemia and rare diseases.
Takeda signs global deal with Halozyme to use ENHANZE technology with vedolizumab, aiming to improve treatment flexibility for IBD patients.
Ascendis Pharma reports positive Week 52 Phase 2 data for once-weekly TransCon CNP and hGH combination in pediatric achondroplasia.
MUSC Health and Baxter announce a multi-year partnership to advance connected care, nursing workflows, and patient safety.
FDA grants Breakthrough Therapy Designation to zoldonrasib for KRAS G12D-mutated NSCLC after prior therapy.
Catalyst Pharmaceuticals ranks 11th on Forbes’ 2026 list of America’s Most Successful Small-Cap Companies.
Dewpoint Therapeutics selects a first-in-class TDP-43 development candidate targeting ALS and related neurodegenerative diseases.
Tango Therapeutics announces CEO transition as Barbara Weber retires and Malte Peters steps in to lead the next growth phase.
Polyrizon finalizes NASARIX™ branding for its PL-14 intranasal allergy blocker ahead of future clinical and commercial steps.
Jazz Pharmaceuticals names Thomas Riga as Chief Business Officer to lead corporate development and strategic partnerships starting January 2026.
Nxera Pharma licenses vamorolone from Santhera to develop and commercialize the DMD therapy across Japan, South Korea, Australia, and New Zealand.
Alps Group names Cheing Lye-Ping as CFO to lead financial strategy as the company enters its next phase of growth and innovation.
CorMedix extends CEO Joseph Todisco’s contract, names him Chairman, appoints Mike Seckler as Chief Commercial Officer.
Pharmapack 2026 returns to Paris on Jan 21–22, uniting global leaders in pharma packaging and drug delivery innovation.
Benitec shares long-term Phase 1b/2a data showing sustained, disease-modifying benefits of BB-301 in OPMD patients.
Royalty Pharma and Teva enter up to $500M funding deal to advance TEV-408, an anti-IL-15 antibody for autoimmune diseases.
Achieve Life Sciences promotes Mark Rubinstein, MD, to Chief Medical Officer as cytisinicline advances toward regulatory review.
Biocartis collaborates with Mayo Clinic to develop a rapid, sample-to-answer breast cancer test to speed treatment decisions.
European Commission approves Biogen’s high-dose SPINRAZA regimen, enabling faster loading and expanded dosing options for SMA patients.
Disc Medicine names Lisa Amaya Price as Chief Human Resources Officer to support organizational growth ahead of commercialization.
Gradalis names Steven D. Weinstein as CEO to lead its personalized cancer immunotherapy platform into the next phase of growth.
AbbVie will acquire West Pharmaceutical’s Tempe device facility to expand drug delivery manufacturing capacity and strengthen pharmaceutical production capabilities in the US.
Bristol Myers Squibb reports positive Phase 3 SCOUT-HCM data for Camzyos in adolescents with obstructive hypertrophic cardiomyopathy.
Medicus Pharma’s Teverelix Phase 1 data accepted at AACE 2026, showing rapid, reversible hormone suppression with favorable safety.
BioMarin names Arpit Davé as EVP and Chief Digital and Information Officer to lead AI, data, and enterprise digital transformation.
Thermo Fisher Scientific collaborates with NVIDIA to integrate AI and automation, accelerating research efficiency and lab innovation.
Amneal Pharmaceuticals launches a new brand identity reflecting its evolution into a diversified global biopharma company.
AbbVie agrees to lower Medicaid drug prices and invest $100B in U.S. R&D under a voluntary federal agreement.
Aligos Therapeutics names James Hassard as EVP and Chief Commercial Officer to strengthen commercial readiness ahead of late-stage development.
FDA approves ZYCUBO, the first U.S. treatment for Menkes disease, marking a major milestone for Fortress Biotech and Cyprium.
FDA grants Breakthrough Therapy Designation to Ipsen’s IPN60340 combo for first-line treatment of unfit AML patients.
Pelthos Therapeutics names finance veteran Andrew Einhorn to its Board, strengthening capital markets and governance expertise.
ImmunityBio shares encouraging QUILT trial data showing immune restoration and survival benefit with ANKTIVA in NSCLC patients.
Baxter unveils its Dynamo Series smart stretcher, designed to ease clinician workload and enhance patient safety and connectivity.
Shuttle Pharmaceuticals supports Utah’s AI refill pilot and highlights Molecule.ai to reduce drug discovery time, cost, and failure risk.
Praxis Precision Medicines names epilepsy leader Dr. Orrin Devinsky to guide late-stage CNS programs toward commercialization.
STEERLife’s FragMelt™ platform helps BionPharma secure USFDA approval for generic Etravirine, advancing sustainable HIV drug manufacturing.
Clearmind Medicine reports all patients in second cohort of Phase I/IIa CMND-100 trial for AUD have successfully completed treatment.
Oncolytics strengthens leadership with new EVP of Strategy and VP of Biostatistics to advance pelareorep registration programs.
Hikma secures B ratings for Climate Change and Water Security in CDP 2025, reflecting stronger governance and progress in sustainability reporting.
GT Biopharma submits FDA IND for GTB-5550, a B7-H3–targeted TriKE NK cell engager, advancing toward Phase 1 solid tumor trials.
Ocugen reports encouraging 12-month Phase 2 data for OCU410, showing reduced lesion growth in geographic atrophy from dry AMD.
Valneva voluntarily withdraws U.S. BLA and IND filings for its chikungunya vaccine IXCHIQ following FDA suspension and safety review.
China’s NMPA has accepted Telix’s NDA for Illuccix, expanding access to PSMA-PET imaging for prostate cancer backed by Phase 3 data.
Hikma launches Enoby and Xtrenbo in the US, expanding access to denosumab biosimilars for osteoporosis and cancer-related bone disease.
Nxera Pharma reports positive Phase 3 results for daridorexant in South Korea and plans regulatory filing in Q1 2026.
MediPharm Labs appoints CFO Greg Hunter as Interim CEO following David Pidduck’s decision to step down in January 2026.
Concept Life Sciences names Dr Adam Davenport as Chief Scientific Officer to strengthen its integrated drug discovery capabilities.
Manthan 2026 R&D Leadership Symposium brought India’s life sciences leaders together to shape the future of research and innovation.
BrightInsight adds senior executives to its leadership team to support global expansion, AI-driven digital health platforms, and biopharma partnerships.
Capricor prepares full HOPE-3 clinical study report for FDA as part of ongoing BLA review for Deramiocel in Duchenne MD.
BrightInsight secures $13M funding to accelerate AI-powered digital health solutions improving medication adherence and persistence.
Novo Nordisk and Aspect Biosystems advance their partnership to develop next-generation cell therapies for diabetes and type 1 diabetes.
Rentschler Biopharma appoints Uwe Buecheler as interim CEO as part of a leadership transition to support long-term growth strategy.
EMA grants orphan drug designation to Rein Therapeutics’ LTI-03, supporting its development for idiopathic pulmonary fibrosis.
Peptinovo Biopharma receives ethics approval in Australia to begin first-in-human clinical trials using PALM™ cancer therapy.
GSK to acquire RAPT Therapeutics, adding Phase IIb anti-IgE antibody ozureprubart to its immunology pipeline.
Moderna and Merck report durable 5-year data for personalized mRNA therapy plus KEYTRUDA in high-risk melanoma.
Bristol Myers Squibb partners with Microsoft to deploy AI-powered radiology tools for earlier lung cancer detection in the U.S.
Corvus Pharmaceuticals reports strong Phase 1 results for soquelitinib in moderate-to-severe atopic dermatitis.
ImmunityBio Meets FDA on ANKTIVA sBLA Expansion
Nxera Pharma establishes a global Metabolic Advisory Council to guide next-generation obesity and metabolic programs.
Crystalys Therapeutics names biotech finance veteran Justin Thacker as CFO as it advances dotinurad into global Phase 3 gout trials.
Charles River and Gazi University collaborate to advance gene therapy research for a rare phosphate disorder using AAV plasmids.
ARS Pharma adds California to its neffyinSchools program, expanding access to needle-free epinephrine nasal spray for school emergencies.
Aligos outlines interim analysis timelines for its Phase 2 B-SUPREME study evaluating pevifoscorvir sodium in chronic HBV patients.
FDA approves use of Greenwich LifeSciences’ first commercial GP2 lot in the Phase III FLAMINGO-01 breast cancer trial.
BioStem expands its advanced wound care portfolio by acquiring BioTissue’s surgical and wound care business and product lines.
Medicus Pharma lowers global royalty rate for Teverelix to 2% after amending its licensing agreement with LifeArc.
NKGen Biotech adds renowned neurologist Dr. Bruce L. Miller to its Scientific Advisory Board to support Alzheimer’s and FTD programs.
Pharmapack announces Pharmapack Asia 2026, launching in Singapore in November 2026 to expand its global pharma packaging footprint.
Pharma Now Podcast features Abhay Kumar Srivastava of Mankind Pharma on Lean manufacturing, quality culture, and ops excellence.
Akari Therapeutics files a US patent for AKTX-102, a first-in-class CEACAM5-targeted ADC using its PH1 RNA-splicing payload.
FDA grants Breakthrough Therapy Designation to Cogent’s bezuclastinib plus sunitinib for imatinib-resistant GIST patients.
GRI Bio receives a new US patent covering novel compound compositions that strengthen its immunomodulatory platform and IP estate.
Eyestem receives CDSCO approval to begin Phase 2 trials of Eyecyte-RPE for geographic atrophy in dry age-related macular degeneration.
Kiora Pharmaceuticals appoints renowned retina specialist Dr. Taiji Sakamoto to advise its retinal disease programs.
Spore.Bio appoints microbiology expert Dr. Michael J. Miller as VP to strengthen regulatory strategy and rapid method validation.
Cardiff Oncology appoints Mani Mohindru as interim CEO to advance onvansertib into late-stage development.
Roche reports positive Phase II data for CT-388, showing up to 22.5% placebo-adjusted weight loss in obesity patients.
Belite Bio completes enrollment in its Phase 2/3 DRAGON II trial evaluating tinlarebant for adolescents with Stargardt disease.
FDA lifts the clinical hold on Intellia’s Phase 3 MAGNITUDE-2 trial of nexiguran ziclumeran for ATTRv-PN patients.
Science 37 names Kelly Johnston McKee as VP of Strategy & Transformation to drive patient-centric innovation and trial modernization.
Quoin submits a Japan Orphan Drug Designation application for QRX003, targeting Netherton Syndrome with Fast Track eligibility.
Propanc Biopharma files a new provisional patent covering novel proenzyme formulations to advance its PRP cancer therapy platform.
Lexeo appoints senior cardiovascular leaders and advances its RNA partnership to accelerate late-stage genetic heart disease programs.
Halo Pharma becomes an independent CDMO following Noramco’s API business sale, sharpening focus on drug product and sterile manufacturing.
CytoDyn receives benefactor funding to support an Expanded Access Program for leronlimab in triple-negative breast cancer patients.
Cloudbreak reports a successful FDA End-of-Phase 2 meeting, paving the way for Phase 3 development of CBT-004 for pinguecula.
Ardelyx doses the first patient in its Phase 3 ACCEL trial evaluating IBSRELA for chronic idiopathic constipation.
BioNTech names Kylie Jimenez as Chief People Officer to support its evolution into a multi-product oncology company by 2030.
Elevar Therapeutics submits an FDA NDA for lirafugratinib as a second-line treatment for FGFR2-driven cholangiocarcinoma.
FDA clears Life Biosciences’ IND for ER-100, enabling first human trials of an epigenetic rejuvenation therapy for vision loss.
Pacira BioSciences adds former BMS CMO Samit Hirawat, MD, to its Board to strengthen leadership in non-opioid pain therapies.
Seamless Therapeutics enters a global research and licensing deal with Eli Lilly to develop recombinase-based gene therapies for hearing loss.
FDA clears Siren Biotechnology’s first IND, enabling a first-in-human AAV-based gene therapy trial for recurrent glioma.
Chugai submits a Japan regulatory filing to expand Tecentriq as adjuvant therapy for MRD-positive muscle-invasive bladder cancer.
FDA grants Breakthrough Therapy Designation to Biogen’s litifilimab for cutaneous lupus erythematosus, supporting accelerated development.
FDA grants Breakthrough Therapy Designation to Immix Biopharma’s NXC-201 for relapsed or refractory AL amyloidosis.
Intelligent Bio Solutions launches a clinical study to support FDA 510(k) clearance of its fingerprint-based codeine test system.
Novartis debuts a national awareness campaign highlighting PSA blood tests as the first step in prostate cancer screening.
Elevar appoints DG Kim as CEO to lead commercialization after NDAs for rivoceranib-camrelizumab and lirafugratinib in liver and bile duct cancers.
Palisade Bio appoints Drs. Peyrin-Biroulet and Rubin to guide PALI-2108 development, strengthening expertise in next-generation IBD therapies.
NurExone names Eyal Gabbai to its board, replacing Dr Gadi Riesenfeld, who will remain with the company on its Scientific Advisory Board.
FDA requests more pediatric data and batch testing info for Joenja® sNDA in children 4–11 with rare APDS; adult approval remains unaffected.
Quotient names Susan Keefe as CFO, adding 30 years of life science finance and Flagship Pioneering experience to support its growth in somatic genomics.
Sparrow Pharmaceuticals adds biopharma veteran Carlo Incerti to its board as the company prepares pivotal trials of clofutriben for type 2 diabetes
Alvotech signs deals with Sandoz to supply and commercialise several biosimilars across Canada and Australia, New Zealand markets.
Novo Medi Sciences launches G.A.U.R.I., a nationwide missed-call campaign to support immunization of underprivileged girl children across India.
OPKO and Entera expand partnership to develop a once-daily oral LA-PTH tablet for hypoparathyroidism, targeting FDA IND in 2026.
Oncolytics’ pelareorep wins FDA Fast Track in 2L KRAS-mutant MSS mCRC after strong survival and response data.
Levicept appoints James Sandy as CDO to lead LEVI-04, a first-in-class osteoarthritis therapy after promising Phase II trial results.
Dewpoint doses first patient in Phase 1a/2a trial of DPTX3186, a first-in-class beta-catenin modulator for advanced solid tumors.
Aprea appoints Dr. Eugene Kennedy as Chief Medical Advisor to advance WEE1 inhibitor APR-1051 after early Phase 1 results in solid tumors.
Bristol Myers Squibb partners with Kasey Keller to share his NHL journey and raise awareness of Breyanzi CAR T therapy.
Bristol Myers Squibb and Johnson & Johnson launch an educational initiative on factor XIa‑targeted strategies to reduce clot risk without increasing bleeding in thromboembolic disease.
Biogen’s DEVOTE study shows higher-dose nusinersen improved motor outcomes in SMA with a safety profile similar to SPINRAZA.
MetaVia and Syntekabio use AI modeling to identify new inflammation, cardiometabolic and cancer targets for vanoglipel beyond MASH and T2D.
Rigel names former Jazz executive Michael Miller to its board, adding four decades of biotech and pharma leadership experience.
LeonaBio names Mark Kubik as CBO to strengthen partnerships, licensing, and strategic growth as the company advances its oncology pipeline.
Adial applauds U.S. legislation directing FDA and NIDA to adopt broader clinical endpoints for addiction and AUD therapies.
Tempest closes an all-stock CAR-T acquisition and financing deal, adding oncology assets and extending its cash runway.
Sun Pharma enters cricket sponsorship as RCB’s Principal Sponsor and Health Partner in a three-year T20 deal to boost brand reach.
Pfizer adds over 30 medicines to TrumpRx with discounts up to 85% and partners with GoodRx to expand prescription affordability.
Cognizant forms a strategic alliance with Palantir to modernise TriZetto and expand governed AI across healthcare and enterprises.
Novo Nordisk criticizes Hims & Hers for mass compounding a semaglutide pill, citing FDA concerns, safety risks, and legal violations.
Alvotech posts positive pharmacokinetic results for AVT80, supporting clinical similarity for SC and IV vedolizumab biosimilars.
Sun Pharma introduces SUNday, a year-round skin cancer awareness initiative focused on education, patient support, and community engagement.
ADARx appoints Dr. Donald Fong as CMO to oversee Phase 3 and Phase 2 trials and drive late-stage RNA therapeutic development.
Polaryx appoints Dr. Mitchel Berger, Francis Braun, and Dr. Charles Ryan to its Board as PLX-200 enters Phase 2 development.
RenovoRx names Mark Voll CFO effective Feb 2026 to drive commercial growth, RenovoCath rollout, and Phase III TIGeR-PaC execution.
New Indian report calls for rapid adoption of non-animal testing to boost drug innovation, reduce R&D costs, and support India’s $500B pharma goal.
Novartis begins construction of a major San Diego research center to advance AI-powered drug discovery as part of its $23B US expansion.
Pfizer secures FDA Priority Review to expand HYMPAVZI use in children and inhibitor hemophilia patients, with a Q2 2026 decision.
Pharma Now podcast features Dr. ARM Rao on pharma quality leadership, compliance strategy, digital QMS, and global regulatory excellence.
Oryzon doses first patient in a Yale-led Phase Ib trial testing iadademstat with radiation and atezolizumab in recurrent ES-SCLC.
China fast-tracks Eisai and Biogen’s subcutaneous LEQEMBI, paving the way for weekly at-home dosing for Alzheimer’s disease patients.
Roche reports Phase III data showing fenebrutinib matched OCREVUS in PPMS, reduced disability risk and supports regulatory filing plans.
Anuh Pharma’s Tarapur manufacturing site clears USFDA inspection with no observations, underscoring global GMP compliance.
Chugai presented Phase I/II data showing NXT007 was well tolerated when hemophilia A patients switched from emicizumab without washout.
Oragenics plans Phase 2 trials of intranasal ONP-002 for concussion and mTBI, targeting rapid brain delivery and early intervention.
Ocugen names Rita Johnson-Greene as CFO, adding 20+ years of gene therapy, finance, and commercial leadership ahead of BLA filings.
Milestone names David Sandoval General Counsel and Chief Compliance Officer as it launches FDA-approved CARDAMYST for PSVT.
Celularity secures USD 12.2M in non-dilutive funding through the sale of New Jersey NOLs and R&D tax credits under the NJEDA program.
Medicus Pharma receives FDA clearance to begin a Phase 2b dose-optimization study of Teverelix in advanced prostate cancer patients.
Chugai licenses Araris’ AraLinQ ADC platform to develop a new oncology program, with upfront payment and milestones worth up to $780M.
FDA accepts Takeda’s oveporexton NDA for narcolepsy type 1 with Priority Review, setting a Q3 decision for a first-in-class orexin therapy.
Enanta will present preclinical data on its KIT inhibitor EDP-978 at AAAAI 2026, highlighting mast-cell targeting and once-daily dosing potential.
Biologics X 3DCC 2026 unites 850+ delegates in Goa, advancing biologics innovation and 3D cell culture technologies.
Madrigal secures global rights to six preclinical siRNA programs for MASH from Ribo in a deal worth up to $4.4B
FDA approves KEYTRUDA plus chemotherapy for PD-L1+ platinum-resistant ovarian cancer based on Phase 3 KEYNOTE-B96 results.
Tempest reports post-transaction plan to advance TPST-2003, expand into in vivo CAR-T, and progress oncology programs with partner funding.
Thermo Fisher and Datavant collaborate to securely link real-world data with clinical trials, strengthening RWE generation for biopharma.
Biogen appoints Dr. Maria C. Freire as Chair of the Board, succeeding Caroline Dorsa following the 2026 Annual Meeting.
Vaxcyte begins OPUS-3 Phase 3 study of VAX-31 in adults previously vaccinated against pneumococcus, supporting a planned FDA BLA.
Mesoblast presents data supporting early Ryoncil® use in SR-aGvHD and plans a pivotal adult trial to expand beyond pediatrics.
Nxera partners with investor-backed NewCo to advance a GPCR asset globally, securing equity, milestones, royalties, and retaining APAC rights.
Oryzon names Rolando Gutierrez-Esteinou as Chief Medical Officer to lead CNS programs and advance vafidemstat into late-stage trials.
BridgeBio reports positive Phase 3 PROPEL 3 results for oral infigratinib in achondroplasia, showing significant height gains and favorable safety.
Cue Biopharma appoints Lucinda Warren as Chief Financial and Business Officer, adding senior finance and deal-making expertise to leadership.
Oncotelic and Sapu strengthen global IP protection for OT-101, expanding CNS, oncology, and intracranial drug delivery coverage.
Roche’s Phase III MAJESTY study shows Gazyva significantly improves complete remission rates in primary membranous nephropathy vs tacrolimus.
SEOPRO showcases AI-driven pharma portfolio governance at Pharma Project Portfolio Management Summit 2026.
Kane Biotech resumes U.S. and Canada sales of revyve® wound gel and appoints new VPs to rebuild North American commercial operations.
NovaBridge doses first patient in Phase 2 trial of givastomig with nivolumab and mFOLFOX6 for HER2-negative metastatic gastric cancer.
Palisade Bio appoints Bram Verstockt, MD, PhD, to guide Phase 2 development of PALI-2108 in ulcerative colitis and Crohn’s disease.
Sana names Brian Piper CFO as it prepares clinical readouts for SC451 in type 1 diabetes and SG293 in B-cell disease.
Telix submits EU marketing application for TLX101-Px brain cancer imaging agent, aligning with upcoming U.S. FDA filing.
Biofrontera locks Phase 1 PK study for Ameluz PDT, supporting a 2026 sNDA to expand actinic keratosis treatment to 240 cm² areas.
EU clears Novo Nordisk’s 7.2 mg Wegovy dose, allowing three 2.4 mg weekly injections for patients needing additional weight loss.
Kane Biotech secures FDA 510(k) clearance for revyve wound cleanser and expands ISO 13485 MDSAP certification under new QMSR.
Oculis appoints Katie Kazem as Chief Legal Officer to lead legal, compliance, and governance as key late-stage programs advance.
Fortrea names Scott Dove President of Clinical Pharmacology Services as Oren Cohen focuses exclusively on Chief Medical Officer duties.
Essential Pharma acquires Ventavis from Bayer and global Breelib rights, strengthening its rare cardio-pulmonary disease portfolio.
Pfizer announces positive PFS results from BREAKWATER Cohort 3 for BRAFTOVI combo in BRAF V600E metastatic colorectal cancer.
FDA accepts BMS NDA for iberdomide combo in relapsed or refractory multiple myeloma and grants Breakthrough Therapy status.
Cue Biopharma shares positive preclinical safety data for CUE-401, showing strong tolerability in mouse and primate studies.
PHARMAP 2026 in Amsterdam explores patient-friendly pharma design with leaders from Bayer AG, HSLU and Sidewise.
Pluri gains China patent for its 3D immune cell expansion technology, expanding global IP protection across key cell therapy markets.
Tarsus names eye-care veteran David Pyott to its Board to support XDEMVY commercialization and advance its ophthalmology pipeline.
Tenvie Therapeutics appoints Don O’Sullivan as CBO to drive corporate and business development as its pipeline nears key clinical milestones.
Zealand Pharma posts positive Phase 1a SAD results for Kv1.3 blocker ZP9830, demonstrating safety, tolerability, and dose-proportional PK.
LIXTE appoints Sidney Braun as CEO of Liora Technologies Europe to drive LiGHT proton therapy expansion and long-term growth.
Crescent Biopharma initiates ASCEND Phase 1/2 trial, dosing first patient with CR-001 for advanced solid tumors.
Aspargo Labs appoints Sam Backenroth as CFO to lead financial strategy and support U.S. and European product launches.
ImmunityBio’s ANKTIVA plus BCG becomes the first authorized treatment in Europe for BCG-unresponsive non-muscle invasive bladder cancer.
Silo Pharma receives Japanese patent allowance for SPC-15, expanding global IP protection for its PTSD treatment candidate.
Novartis posts positive Phase III RemIND results for remibrutinib in chronic inducible urticaria and submits sNDA to FDA.
Charles River appoints Glenn Coleman as CFO and Kerry Dailey as Chief Legal Officer to strengthen leadership and drive long-term growth.
Theriva out-licenses SYN-020 to Rasayana in a deal worth up to $38M plus royalties, granting global development and commercial rights.
Syntegon unveils AIM9, a 600 vials/min inspection platform with integrated CCIT and AI-powered visual defect detection.
Sandoz signs new European vPPAs under the Energise program to reduce Scope 2 emissions and boost renewable energy across its supply chain.
Merck teams up with Mayo Clinic to harness AI, genomic and multimodal data to accelerate early-stage drug discovery and development.
Candel Therapeutics lands $100M royalty financing from RTW to fund aglatimagene launch in early prostate cancer, pending FDA approval.
Starton Therapeutics doses first patient in Phase 2a STAR-LLD study for relapsed/refractory multiple myeloma, expanding to six U.S. sites.
Serina Therapeutics enrolls first patient in Phase 1b registrational trial of SER-252 for advanced Parkinson’s disease.
Kane Biotech broadens U.S. reach of its revyve® wound care line through new distribution deals with Patient Care Medical and Life Biologics.
Merck shares positive second RSV season data for ENFLONSIA in high-risk children, with Phase 3 SMART trial supporting broader use.
Chugai launches ELEVIDYS gene therapy for Duchenne muscular dystrophy in Japan following conditional approval and NHI listing.
NovaBridge names Emmett Cunningham Jr. Vice Chairman and R&D Committee member, strengthening biotech leadership and innovation strategy.
Artiva Biotherapeutics names Elaine Sorg to Board to guide AlloNK development for rheumatoid arthritis and autoimmune diseases.
Zenyaku and Chugai secure Japan MHLW approval to expand Rituxan use to autoimmune hemolytic anaemia under public knowledge-based application.
AtaiBeckley names Michael Faerm CFO as BPL-003 advances toward Phase 3; Anne Johnson transitions to Chief Accounting Officer.
ImmunityBio partners with Accord Healthcare to commercialise ANKTIVA in Europe and launches Irish subsidiary to strengthen EU operations.
Outlook Therapeutics signs exclusive deal with Mediconsult AG to distribute LYTENAVA™ (bevacizumab gamma) in Switzerland for retina diseases.
AstraZeneca’s Calquence plus venetoclax approved in the US based on Phase III AMPLIFY results as first fixed-duration oral CLL/SLL regimen.
AstraZeneca’s Calquence plus venetoclax wins FDA approval as the first fixed-duration, all-oral regimen for first-line CLL and SLL treatment.
FDA accepts Roche’s NDA for giredestrant plus everolimus in ER-positive, ESR1-mutated advanced breast cancer; decision due December 2026.
MoonLake shares positive Phase 2 sonelokimab results in axSpA and reports 2025 financial results with $394M cash position.
Takeda reports positive Phase 3 KEPLER results, with ENTYVIO achieving remission and showing safety in pediatric ulcerative colitis.
Dr. François Nader appointed Chair and independent director at Tectonic Therapeutics, bringing 30+ years of biotech leadership experience.
Palisade Bio presents clinical, histologic and RNA-seq data showing targeted activity of PALI-2108 at ECCO 2026.
Former Pfizer CSO Dr. Mikael Dolsten joins Neutrolis as Executive Director to advance fast-acting, NET-targeting therapies.
AIM ImmunoTech shares Phase 2 DURIPANC study progress evaluating Ampligen® with Imfinzi® in metastatic pancreatic cancer after FOLFIRINOX.
Akari Therapeutics appoints RNA biology and cancer research leader Dr. Olga Anczukow to its Scientific Advisory Board.
Fortress Biotech and Cyprium Therapeutics sell rare pediatric priority review voucher for $205M following FDA approval of ZYCUBO.
Kyntra Bio to present Phase 1b/2 data on FG-3246 plus enzalutamide in mCRPC at ASCO GU 2026, showing encouraging rPFS results.
AbbVie will invest $380M to build two AI-integrated API facilities in North Chicago, expanding U.S. manufacturing and creating 300 jobs.
Adial points to new FDA evidentiary flexibility as it advances AD04 for Alcohol Use Disorder and plans regulatory alignment
Foghorn names Ryan Maynard CFO, adding 25+ years of biotech finance and capital markets experience to support pipeline growth.
BMS announces positive Phase 2 results for Reblozyl in alpha-thalassemia, meeting primary endpoints in NTD and TD patients.
Merck splits Human Health into Oncology and Specialty units, naming new leaders to support launches and long-term growth.
European Commission approves Sandoz’s Ranluspec ranibizumab biosimilar for retinal diseases, with EU launch planned in 2H 2026.
IDEAYA names Dr Theodora Ross Chief Development Officer to lead early oncology development and shape long-term R&D strategy.
Novo Nordisk reports 23% weight loss with CagriSema in REDEFINE 4 but misses non-inferiority to tirzepatide at 84 weeks.
Serina doses first patient in Phase 1b registrational SER-252 trial for advanced Parkinson’s, targeting 505(b)(2) pathway.
Transpire Bio Inc. names R. LaDuane Clifton CFO to support its transition from clinical to commercial-stage operations.
Siren Biotechnology secures FDA Fast Track and IND clearance for SRN-101 in recurrent high-grade glioma.
Sanofi and Regeneron secure U.S. Food and Drug Administration approval for Dupixent in allergic fungal rhinosinusitis.
Novo Nordisk will reduce U.S. list prices of Wegovy, Ozempic and Rybelsus to $675 starting January 2027.
Ardelyx and Ladies Professional Golf Association partner to boost IBS-C education through digital outreach and LPGA Tour activations.
Cosmos Health Inc. appoints Dimitrios Iliopoulos to advance AI-powered drug discovery and clinical development initiatives.
Kyverna Therapeutics appoints Sravan Emany and Andrew Miller to its Board, supporting growth of its autoimmune CAR T pipeline.
EMA authorizes Oryzon’s Phase II IDEAL study of iadademstat in essential thrombocythemia patients resistant to hydroxyurea.
TUL and Novo Nordisk report 19.7% weight loss in a Chinese Phase 2 trial of UBT251 triple agonist for obesity.
Pfizer secures full FDA approval for BRAFTOVI plus cetuximab and chemotherapy in BRAF V600E-mutant metastatic colorectal cancer.
Werewolf Therapeutics appoints Piper Sandler to explore strategic alternatives to advance its PREDATOR platform and oncology pipeline.
Aktis Oncology secures FDA Fast Track designation for AKY-1189, a Nectin-4-targeted radiopharmaceutical for metastatic urothelial cancer.
Paratek reports positive Animal Rule data for NUZYRA in pulmonary anthrax, securing additional BARDA procurement support.
INTERPHEX WEEK TOKYO 2026 at Makuhari Messe features 950 exhibitors, 35K professionals, 320+ seminars on pharma manufacturing, DX, and regenerative medicine expo.
Zydus Lifesciences Limited plans India semaglutide launch after patent expiry with reusable adjustable pen under SEMAGLYN, MASHEMA and ALTERME.
Tempest Therapeutics, Inc. reports 100% response rate for TPST-2003 CD19/BCMA CAR-T in REDEEM-1 Phase 1/2a study.
Rivus Pharmaceuticals Inc. appoints Jorge Bartolome CEO as it advances HU6 and obesity pipeline programs.
Novo Nordisk partners with Vivtex Corporation in a $2.1B agreement to develop oral biologics for obesity and diabetes.
Merck & Co. announces positive Phase 3 results for doravirine/islatravir (DOR/ISL), showing non-inferior efficacy in HIV-1.
Intelligent Bio Solutions deploys first Syrma Johari-manufactured fingerprint drug readers, targeting 40% cost savings and U.S. market expansion.
GSK’s ViiV Healthcare reports Phase 1 VH184 data showing 6-month drug levels; VH499 capsid inhibitor supports twice-yearly HIV dosing.
ViiV’s EMBRACE Phase IIb shows 94% viral suppression at 12 months with IV lotivibart plus CAB LA, supporting twice-yearly HIV dosing.
GSK to acquire 35Pharma for $950M, adding Phase I HS235 targeting activin signalling in pulmonary hypertension and PH-HFpEF.
AMA approves Category III CPT code X566T to track CED delivery of Plus Therapeutics’ REYOBIQ in rGBM and pediatric brain cancer.
FDA approves Merck Animal Health’s NUMELVI (atinvicitinib), first second-gen JAK inhibitor for pruritus in canine allergic dermatitis.
Hikma launches authorised generic Nucynta (tapentadol) IR in the US; brand posted $157M sales in 2025, expanding opioid pain portfolio.
Novartis to build 46,000 sq ft RLT facility in Denton, Texas, its fifth US site, under a $23B investment to scale radioligand therapy supply.
IDEAYA enrolls first patient in Phase 1 IDE034 (PTK7/B7H3 TOP1 ADC), triggering $5M Biocytogen milestone; combo cohorts with IDE161 planned.
India Pharma Expo 2026 at HITEX Hyderabad features 300+ exhibitors, NextGen Awards, buyer-seller meets on Pharma 4.0, biosimilars, AI, and global partnerships.
Rhythm’s Phase 3 TRANSCEND shows 16.4% BMI reduction with setmelanotide in acquired HO; FDA PDUFA set for March 20, 2026.
Roche’s Phase III FENhance 1 shows fenebrutinib reduces ARR 51% vs teriflunomide in RMS; safety and mortality data under review.
Septerna’s Phase 1 data show SEP-631, an oral MRGPRX2 NAM, achieved strong mast-cell inhibition; Phase 2b in chronic spontaneous urticaria planned.
Japan’s MHLW grants orphan designation to rilzabrutinib for IgG4-RD after positive Phase 2 data; Phase 3 RILIEF trial ongoing.
FDA accepts Opus Genetics’ sNDA for phentolamine ophthalmic solution 0.75% in presbyopia; PDUFA set for Oct 17, 2026.
Longeveron’s Phase 2b data in Cell Stem Cell show laromestrocel (LOMECEL-B) improved 6MWT by 63m at 9 months in frailty patients vs placebo.
Eminence Business Media's 6th Pharma GMP & Quality Management 2026 in Mumbai covers audit readiness, AI-driven quality, deviation management, and post-event implementation clinic.
Pharma Quality Excellence Awards 2026 celebrate GMP maturity, leadership, and resilient quality systems driving sustainable excellence in pharmaceutical organizations.
Seres Therapeutics appoints Richard Kender Interim CEO as SER-155 nears Phase 2 and Q2 2026 irEC data from MSKCC study.
Hepion licenses ctRNA liquid biopsy from Cirna Diagnostics to detect early hepatocellular carcinoma, expanding its HCC precision diagnostics pipeline.
Adial enters exclusivity with Molteni to commercialize AD04 in Europe; deal worth up to $60M in milestones and royalties ahead of Phase 3.
EMA’s CHMP adopts negative opinion on Acadia’s trofinetide for Rett syndrome despite positive LAVENDER trial; re-examination planned.
Acadia Pharmaceuticals appoints Vertex SVP Finance Jonathan Poole to its Board and Audit Committee to bolster financial oversight and growth strategy.
GSK completes $2.2B RAPT Therapeutics acquisition, gaining Phase IIb anti-IgE mAb ozureprubart for food allergy; Phase III planned.
Teva inks $400M funding deal with Blackstone Life Sciences to advance Phase 3 TL1A antibody duvakitug in UC and Crohn’s, with milestones and royalties.
Moderna reaches $950M global settlement with Arbutus and Genevant over Spikevax and RSV IP; potential $1.3B contingent under Section 1498 appeal.
AIM ImmunoTech reports ~$1.8M in preliminary subscriptions after its rights offering expired, funding development of Ampligen for pancreatic cancer.
Alterity appoints neurologist Daniel Claassen as Chief Medical Advisor as ATH434 moves toward Phase 3 development for multiple system atrophy.
CervoMed completes Phase 1 PK study of stable neflamapimod crystal form and selects 50 mg TID dosing for upcoming Phase 3 dementia with Lewy bodies tria
Clearmind’s Phase I/IIa CMND-100 trial in alcohol use disorder continues after DSMB safety review confirms favorable tolerability in the second cohort.
Genvor enters the health and wellness sector using its AI-driven BioCypher platform to develop peptide-based consumer products for recovery, immunity and wellness
HUTCHMED doses first patient in Phase I/IIa trial of HMPL-A580, an EGFR-targeted ATTC with PI3K/PIKK inhibitor payload for advanced solid tumors.
NervGen Pharma appoints Shamim Ruff as Chief Regulatory Affairs Officer and Christine McSherry as SVP as NVG-291 spinal cord injury program advances.
Lifecore Biomedical to produce engineering and clinical batches of DT-001 for Indomo as the acne therapy advances toward Phase 2 trials with the ClearPen device.
Allergan Aesthetics reports GLP-1 weight-loss patients increasingly seek hyaluronic acid fillers to address facial volume loss after rapid weight reduction.
Thermo Fisher Scientific launches an $18M immunodiagnostics distribution centre in Uppsala to boost global supply of allergy and autoimmune IVD tests.
Glenmark Pharmaceuticals receives U.S. Food and Drug Administration approval for generic Fluticasone Propionate inhaler with 180-day CGT exclusivity in the U.S.
Achieve Life Sciences reports Phase 3 data showing Cytisinicline helps smokers quit regardless of prior cessation therapy or quit attempts.
Entera Bio submits Phase 3 protocol amendment to FDA for oral teriparatide candidate EB613 to treat osteoporosis.
Nxera Pharma seeks South Korea approval for insomnia drug Daridorexant following successful Phase III trial results.
Keros Therapeutics appoints Charles Newton to its board as rinvatercept (KER-065) advances, reinforcing finance and capital markets oversight.
Zealand Pharma reports Phase 2 results showing up to 10.7% weight loss with Petrelintide in adults with obesity.
Tevogen Bio Holdings Inc. signs LoI to explore acquiring Apozeal Pharmaceutical Inc. to strengthen U.S. generics manufacturing and drug supply.
Tenaya Therapeutics and Alnylam Pharmaceuticals collaborate to identify genetic targets and develop RNAi-based treatments for cardiovascular disease.
Roche Holding AG reports strong Phase II results for petrelintide, showing significant weight loss and favorable safety in obesity patients.
Pacific Biosciences of California Inc. appoints Recursion co-founder Christopher Gibson to its board, boosting AI and data science expertise.
Kestrel Therapeutics Inc. gets FDA clearance for KST-6051, advancing a Phase 1 trial in KRAS-mutant cancers.
Invivyd Inc. appoints Dr. Michael Mina as CMO to advance monoclonal antibody programs for viral prevention.
Galapagos NV appoints Tania Philipp as Chief Human Resources Officer to strengthen leadership and support its ongoing strategic transformation.
Avalyn Pharma names former Blueprint Medicines CEO Kate Haviland to its board as it advances inhaled antifibrotic therapies for pulmonary fibrosis.
Sangamo Therapeutics submits clinical and preclinical modules to the U.S. Food and Drug Administration for Fabry gene therapy ST-920 BLA review.
Mineralys Therapeutics wins U.S. Food and Drug Administration NDA acceptance for hypertension drug lorundrostat; PDUFA decision set for Dec 22, 2026.
LB Pharmaceuticals names neuroscience executive Robert Lenz to its board as it advances late-stage development of LB-102.
Cytek Biosciences celebrates one year of its Singapore hub, boosting APAC manufacturing, training, and cell analysis support.
Biofrontera Inc. reports positive Phase 2b results for Ameluz PDT, supporting further development for moderate to severe acne treatment.
AEON Biopharma names John Bencich CFO as it prepares regulatory progress for ABP-450, a biosimilar to BOTOX.
Actuate Therapeutics begins expanded research to test elraglusib with emerging RAS-targeted therapies, aiming to overcome resistance in RAS-driven cancers.
BSE-listed Anuh Pharma secures EDQM GMP approval for Tarapur facility after successful European audit, reinforcing global quality standards for API manufacturing.
Santhera Pharmaceuticals names Marc Clausse Chief Commercial Officer to expand global access to AGAMREE for Duchenne muscular dystrophy.
Propanc Biopharma teams with FyoniBio GmbH to develop an LC-MS PK assay supporting PRP therapy in a first-in-human cancer study.
Polyrizon Ltd. completes GMP clinical batch with Eurofins CDMO AmatsiAquitaine S.A.S, advancing its intranasal therapy toward a U.S. study.
Oragenics, Inc. receives HREC approval in Australia to start Phase IIa trial of ONP-002, an intranasal therapy for concussion.
Karen Basbaum joins MBX Biosciences as CBO to advance strategic growth and precision peptide therapies.
Celularity enters strategic partnership to monetize placental-derived biomaterials while focusing on longevity-focused cellular therapies.
Cassava Sciences becomes Filana Therapeutics to focus on filamin A-based treatments for CNS disorders, including TSC-related epilepsy.
Curanex adds two experts to its Scientific Advisory Board, bringing 75 years of experience to strengthen strategy and drug development.
Mainz Biomed appoints Robert Liscouski as Chairman and will rebrand as Quantum Cyber with new Nasdaq ticker QUCY launching March 12, 2026.
Quoin Pharmaceuticals earns FDA Fast Track Designation for QRX003 lotion, advancing treatment development for rare Netherton Syndrome.
Bavarian Nordic and Serum Institute sign a new manufacturing deal to scale production of the CHIKV VLP chikungunya vaccine.
Clearmind starts enrolling the third cohort in its FDA-approved Phase I/IIa trial of CMND-100, a non-hallucinogenic treatment for alcohol use disorder.
Commit Biologics names Thomas Andresen CEO as it advances toward clinical development following €21.5M in seed funding.
Telix resubmits its Pixclara NDA to the FDA with new data, aiming to improve glioma imaging and provide clearer diagnosis for adult and pediatric patients.
Firebrick Pharma Limited appoints Nilesh Wadhwa to lead global business development and licensing from April 2026.
Roche scales AI infrastructure with NVIDIA GPUs to speed drug discovery, genomics analysis, and digital diagnostics innovation.
Rhythm Pharmaceuticals, Inc. says Phase III EMANATE trial of Setmelanotide missed primary endpoints but showed benefit in genetic obesity subgroups.
Baxter CFO Joel Grade steps down; Anita Zielinski named interim CFO as the company begins search for a permanent successor.
Monte Rosa Therapeutics, Inc. partners with Johnson & Johnson to study MRT-2359 with ERLEADA in Phase II metastatic prostate cancer trial.
Greenwich LifeSciences, Inc. moves Phase III GLSI-100 trial forward as FDA approves commercial GP2 supply for breast cancer recurrence prevention.
European Commission clears AstraZeneca’s Imfinzi plus chemotherapy for Gastric Cancer based on strong Phase III survival data.
Amlogenyx Inc. says preclinical studies show AM805 gene therapy reduces brain amyloid in Alzheimer’s disease.
George Medicines signs licensing deal with Arrotex Pharmaceuticals to commercialize GMRx2 for Hypertension in ANZ.
HCW Biologics Inc. study finds HCW9206 enhances CAR‑T cell therapy potency and persistence in preclinical cancer and HIV models.
Recludix Pharma promotes Ajay Nirula to president and Catherine Bovenizer to CFO to advance innovation and growth.
Spyre Therapeutics completes RA enrollment in SKYWAY Phase 2 study of SPY072. Topline data expected in Q3 2026.
Cogent Biosciences NDA for bezuclastinib in non-advanced systemic mastocytosis accepted by U.S. Food and Drug Administration; decision due Dec 2026.
Allergan Aesthetics launches Skin Quality Index to standardise aesthetic terminology and enhance patient-provider communication in skin treatment planning.
Alamar Biosciences introduces NULISAseq Neuro 220 Panel for ultra-sensitive multiplex detection of neurological biomarkers in neurodegenerative disease studies.
Clearmind Medicine Inc. receives publication of six Hong Kong patents for PEA-based psychedelic formulations to expand its mental health drug pipeline.
Dyadic Applied BioSolutions partners with Integrated Biotherapeutics to distribute recombinant proteins worldwide under an OEM agreement.
NovaBridge Biosciences gains positive U.S. Food and Drug Administration feedback on accelerated approval strategy for givastomig in gastroesophageal cancer.
Transpire Bio names Ewan Livesey Head of Business Development to drive licensing and partnerships for its inhaled therapeutics pipeline.
Polyrizon signs a CRO pact to run GLP biocompatibility tests under ISO 10993, targeting first-in-human trials for its intranasal device platform.
PolyPid secures a $4.3M PDUFA fee waiver from FDA, clearing the path to file its NDA for D-PLEX100 to prevent surgical site infections.
Zydus and Lupin partner to co-market semaglutide injection in India under five brand names, targeting type 2 diabetes and obesity management.
Pfizer's Phase 2 FOURLIGHT-1 trial shows atirmociclib plus fulvestrant improves PFS in HR+/HER2- metastatic breast cancer post CDK4/6 therapy.
Ascendis Phase 2 New InsiGHTS trial shows once-weekly TransCon hGH matches daily somatropin growth rates in children with Turner syndrome.
HCW Biologics receives $7M upfront from Beijing Trimmune for HCW11-006 China license, with milestones, royalties, and reacquisition rights retained.
Neuronetics appoints Dan Reuvers as President and CEO from March 23, 2026, succeeding Keith Sullivan who retires after five years at the helm.
NCCN 2026 guidelines now include ANKTIVA plus BCG for BCG-unresponsive papillary-only NMIBC, expanding coverage beyond CIS bladder cancer patients.
Greenwich LifeSciences Phase III FLAMINGO-01 data shows GLSI-100 cuts breast cancer recurrence to 0.7% annually, an 83% drop vs historical control.
Clearmind Medicine advances CMND-100 Phase I/IIa trial third cohort for alcohol use disorder with no serious adverse events at Yale and Johns Hopkins.
Collegium Pharmaceutical acquires AZSTARYS from Corium for $650M, adding the first dual-release ADHD capsule to its portfolio alongside JORNAY PM.
Curia expands Glasgow sterile fill-finish facility by 2027 and upgrades its CHO-based cell line platform with 6x higher titers for biologics partners.
Kaida BioPharma appoints full executive team to advance KAD-101, a prolactin receptor antagonist, toward IND filing and first-in-human trials for recurrent ovarian cancer.
Remix Therapeutics gains FDA Fast Track for REM-422, a first-in-class MYB mRNA degrader in Phase 1/2 ARIA trial for recurrent or metastatic ACC.
Annovis Bio partners with NeuroRPM to use an FDA-cleared AI platform in its buntanetap Parkinson's trial, tracking tremor and bradykinesia as digital biomarkers.
BOOST Pharma appoints Elaine Jones, PhD, ex-Pfizer Ventures, as Board Chair to advance BT-101 cell therapy into Phase III trials for brittle bone disease.
Allergan Aesthetics launches AA Signature™ Skin360+ and global research at AMWC 2026, showing 62% of patients prefer structured combination aesthetic treatment plans.
Chugai submits Japan device application for ranibizumab Port Delivery System, backed by Phase III Archway and Pagoda trial data; drug filing targeted for 2026.
Greenwich LifeSciences expands FLAMINGO-01 Phase III trial with City of Hope sites, advancing GLSI-100 HER2-positive breast cancer vaccine with Dr. Hope Rugo as investigator.
CellCarta and Biofidelity sign exclusive multi-year deal for Aspyre® Lung in clinical trials, offering 4–5 day targeted genomic testing with 99% success rates for lung cancer studies.
Pfizer's TALAPRO-3 Phase III trial shows TALZENNA plus XTANDI significantly extends progression-free survival in HRR-mutated metastatic castration-sensitive prostate cancer.
FDA approves Novo Nordisk's Wegovy® HD semaglutide 7.2mg for chronic weight management with 20.7% weight loss in STEP UP trials; U.S. launch set for April 2026.
FDA approves Rhythm Pharmaceuticals' IMCIVREE® as first therapy for acquired hypothalamic obesity, with Phase III TRANSCEND data showing 18.4% placebo-adjusted BMI reduction.
FDA approves GSK's Lynavoy (linerixibat) as first U.S. therapy for cholestatic pruritus in PBC; Phase III GLISTEN trial shows rapid, sustained itch relief within two weeks.
Novartis acquires SNV4818, a mutant-selective PI3Kα inhibitor for HR+/HER2- breast cancer, from Synnovation in a deal worth up to $3B.
Macau approves ImmunityBio's ANKTIVA for bladder cancer, marking the therapy's first authorisation in Asia via reliance on US and EU reviews.
Opdivo wins new US and EU approvals for classical Hodgkin lymphoma, supported by strong survival and progression-free outcomes.
Glenmark launches affordable semaglutide GLIPIQ in India for Type 2 diabetes, offering vial and pen options with a patient support program.
Zydus launches semaglutide injection in India with reusable multi-dose pen, cutting diabetes and obesity treatment costs after patent expiry.
HUTCHMED starts Phase III trial of HMPL-760 plus R-GemOx in relapsed/refractory DLBCL in China; 240 patients planned for enrollment.
Roche halts emugrobart trials in SMA and FSHD due to limited efficacy, while the obesity program continues; no safety issues reported.
GSK's B7-H3 ADC Ris-Rez earns Japan orphan status for SCLC after promising early data, now holding six global regulatory designations including FDA Breakthrough Therapy.
Roche launches Building 92 in Basel for its IHB, combining organoids, organ-on-chip & AI to speed up drug discovery, backed by CHF 41B Swiss investment.
Pfizer and Valneva report Phase 3 results for PF-07307405 Lyme vaccine with ~74% efficacy and plan regulatory submissions.
Tarsus earns $15M after China approves TP-03 for Demodex blepharitis; Grand Pharma to commercialise across Greater China.
Oryzon gains US patent for iadademstat and venetoclax combo in AML, extending protection to 2039 and supporting ongoing clinical trials.
Theriva aligns with FDA on Phase 3 design for VCN-01 in metastatic pancreatic cancer with chemotherapy, supporting future biologics license plans.
Japan approves Chugai’s Lunsumio and Polivy combo for relapsed large B-cell lymphoma based on Phase 3 data showing improved response and PFS.
Adial Pharmaceuticals backs AD04 under U.S. bill for alcohol use disorder, expanding research access and supporting non-abstinence treatment for veterans.
AbbVie partners with MLB to expand cancer research funding via Striking Out Cancer, supporting nationwide awareness and treatment through per-strikeout donations.
Thermo Fisher acquires Clario to boost clinical trial data solutions, strengthening biopharma services and accelerating drug development capabilities.
Ocugen reports OCU410 Phase 2 data in geographic atrophy, reducing lesion growth and supporting Phase 3 trial in dry age-related macular degeneration.
Amylyx completes Phase 3 trial enrollment for avexitide in post-bariatric hypoglycemia, with Q3 2026 data and potential 2027 launch planned.
Japan approves Dupixent by Regeneron and Sanofi for bullous pemphigoid, improving remission rates in Phase 2/3 trial for autoimmune skin disease.
Novo Nordisk and United Labs report UBT251 Phase 2 data in type 2 diabetes, showing better HbA1c reduction and weight loss than semaglutide.
Oryzon secures USPTO allowance for vafidemstat in borderline personality disorder, strengthening CNS patent protection through 2040.
Takeda announces restructuring to save JPY 200B by 2028, supporting oveporexton, rusfertide and zasocitinib launches and pipeline growth.
Recursion appoints Vicki Goodman as CMO to lead clinical strategy and advance pipeline programs toward key regulatory milestones.
Thermo Fisher and SHL Medical expand Ridgefield to integrate Molly autoinjector with sterile fill-finish for chronic disease drug-device products.
Oragenics reports going concern warning in FY2025 audit under NYSE rules, highlighting financial risk with no changes to prior financial statements.
Artelo expands ART27.13 into GLP-1 therapy to address muscle loss, backed by trial data and a new patent in metabolic and obesity treatment space.
Circio collaborates on circVec RNA therapy for CAR-M targeting cancer, fibrosis, and autoimmune diseases using in vivo delivery approach.
Novo Nordisk gains FDA approval for Awiqli insulin for type 2 diabetes, a once-weekly basal insulin backed by Phase 3 ONWARDS trial results.
Disc Medicine completes Phase 3 APOLLO trial enrollment of bitopertin for erythropoietic protoporphyria, with topline data expected in Q4 2026.
Shuttle Pharma upgrades molecule.ai platform with advanced AI models and autonomous agents to improve drug discovery and candidate selection workflows.
Rhythm Pharmaceuticals receives EMA CHMP opinion for IMCIVREE to treat hypothalamic obesity, with European Commission decision expected in Q2 2026.
Plus Therapeutics appoints industry veteran Ron Andrews to its board, strengthening its leadership with decades of experience in diagnostics and biotech.
ImmunityBio’s Phase 3 QUILT trial meets power criteria, with IDMC confirming no further enrollment needed to assess ANKTIVA + BCG efficacy.
Tonix begins Phase 1 study of TNX-1900 to evaluate trigeminal neurovascular effects, advancing research into migraine-related mechanisms.
Novartis reports Fabhalta slowed kidney decline, cut major risks, and improved proteinuria in final two-year APPLAUSE-IgAN Phase III result
Roche launches cobas MPX-E assay in CE-mark markets, enabling multi-virus blood screening with improved sensitivity and streamlined lab workflows.
Bristol Myers Squibb reports positive Phase 3 results for Camzyos in adolescents with oHCM, showing improved heart function and a strong safety profile.
Praxis gets FDA priority review for relutrigine, a potential first targeted therapy for SCN2A and SCN8A DEEs, with a PDUFA date of Sept 27, 2026.
Transcenta names Dr. Christopher Hwang Head of Global Partnerships to expand HiCB bioprocessing platform through global licensing and strategic collaborations.
Vor Bio begins dosing in the global Phase 3 UPSTREAM SjD trial testing telitacicept for primary Sjögren’s disease, a condition with no approved disease-modifying therapy.
Zymeworks Inc. receives FDA Fast Track for ZW191 in platinum-resistant ovarian cancer, aiming to accelerate development for advanced disease patients.
ACESOT-1051 trial of APR-1051, showing early promise for patients with biomarker-defined solid tumors
Aquestive completes an FDA Type A meeting and plans to resubmit its Anaphylm oral epinephrine NDA in Q3 2026, advancing a first-of-its-kind rescue treatment
Clearmind Medicine completes treatment and follow-up for 18 participants in its Phase I/IIa CMND-100 trial for Alcohol Use Disorder, showing strong safety progress
Immix Biopharma finishes NEXICART-2 enrollment as it prepares topline 2026 results and a BLA for NXC-201, a potential first treatment for AL Amyloidosis.
BridgeBio reports 54-month data showing acoramidis reduces mortality and sustains quality of life in ATTR-CM, reinforcing the benefits of early treatment.
Medicus Pharma reports KOL validation of SkinJect® data, showing strong efficacy in BCC and supporting its potential as a non-surgical treatment option.
GSK’s bepirovirsen NDA accepted in China, showing strong Phase III results and potential to improve low functional cure rates in chronic hepatitis B.
GSK’s Exdensur approved in China for severe asthma, showing strong reduction in exacerbations with just two doses per year in Phase III trials.
Baxter launches IV Verify system to improve IV labelling, reduce medication errors, and enhance nurse efficiency through automated, standardised labelling.
BridgeBio submits FDA NDA for BBP-418, a potential first treatment for LGMD2I/R9, backed by positive Phase 3 results and multiple regulatory designations.
Biogen’s high-dose SPINRAZA was approved by the FDA, showing improved motor function in SMA patients with a new dosing regimen and consistent safety profile.
Acurx secures new Korea patent for DNA Pol IIIC inhibitors, strengthening IP for its antibiotic pipeline targeting drug-resistant Gram-positive infections.
MAIA Biotechnology shows 2+ year overall survival in 8 NSCLC patients in Phase 2 THIO-101 trial after ateganosine and cemiplimab treatment.
Onconetix appoints David White as CEO and adds Sammy Dorf to its Board as the company advances its planned acquisition of Realbotix and prepares for growth.
Proxygen appoints Chiara Conti, Ph.D., as CSO to lead clinical development and advance its molecular glue and proximity-based therapeutics pipeline.
Trethera partners with MGH to test TRE-515 in advanced ALS under FDA Expanded Access for safety and disease tracking.
Serenity Medical’s River™ stent gets FDA approval as the first device for drug-resistant idiopathic intracranial hypertension.
Eli Lilly will buy Centessa Pharmaceuticals to advance orexin agonist therapies for sleep and neurological disorders in a $6.3 billion deal.
Ambros Therapeutics gets USPTO allowance for CRPS-1 patent, boosting IP and neridronate exclusivity through 2045.
Adcytherix starts Phase 1 trial of ADCX-020, expands leadership, and advances its ADC pipeline for global oncology development.
BMS expands Standing in the Gaap program to improve equitable multiple myeloma care, launching a major survey to address gaps in underserved communities.
Efzimfotase alfa shows positive Phase 3 results in hypophosphatasia, improving bone health in children and showing benefits in select adult patient groups.
Biogen to acquire Apellis for $5.6B, adding key complement therapies and boosting revenue growth with approved drugs EMPAVELI® and SYFOVRE®
Agios plans FDA accelerated approval for mitapivat in sickle cell disease, following positive RISE UP data and regulatory guidance on confirmatory trials.
Express Scripts adds CARDAMYST nasal spray to formularies, expanding access to a self-administered treatment for PSVT episodes in the U.S.
Tarsus begins Phase 2 trial of TP-05, an oral therapy designed to prevent Lyme disease by killing infected ticks before transmission.
Thermo Fisher launches Glacios 3 Cryo-TEM, enhancing cryo-EM imaging with AI, improved workflows, and broader lab accessibility.
ORIC reports strong Phase 1b data for rinzimetostat in prostate cancer, selecting 400 mg dose and advancing to Phase 3 Himalayas-1 trial.
Kala Bio brings in Dr. Saeid Babaei as Senior Scientific Advisor to guide AI-driven evaluation of its cell and gene therapy programs and secretome platform.
Oncolytics Biotech completes its move to Nevada and establishes a new U.S. headquarters in San Diego to enhance operations and access to U.S. capital markets
Telix appoints David Gill as Non-Executive Director, with plans for him to transition to Board Chair as part of the company’s leadership expansion.
Zymeworks appoints Kristin Stafford as CFO, bringing strong life sciences, finance, and capital markets expertise to support its strategic growth.
AskBio completes final randomization in its Phase 2 GenePHIT trial for AB-1002, marking key progress in developing new treatment options for HFrEF patients.
AAVantgarde Bio appoints Philip Lao as Senior VP to lead strategic partnerships and support growth in developing therapies for inherited retinal diseases.
Ardelyx names Dr. Rajani Dinavahi as CMO to advance programs in immuno-oncology and nephrology, bringing over 20 years of clinical and biotech experience
Rusan introduces APOSAN 3ml Pen, a portable multi-dose apomorphine device for managing OFF episodes in Parkinson’s disease patients in India.
Lilly wins FDA approval for Foundayo, an oral obesity drug, showing strong weight loss results and expanding access with affordable pricing options.
Thermo Fisher launches CHOvantage GS platform to speed biologics development with high yields, faster timelines, and royalty-free licensing.
Vertex gains FDA approval to expand ALYFTREK and TRIKAFTA use, enabling more cystic fibrosis patients to access CFTR-modulating treatments.
Ocugen completes dosing early in Phase 2/3 trial of OCU410ST gene therapy for Stargardt disease, with BLA submission planned for 2027.
AstraZeneca’s EMERALD-3 trial shows improved PFS with Imfinzi-based combo in liver cancer, with early signs of survival benefit.
Merck launches Phase 2b/3 MALBEC trial for MK-8748 in wet AMD, advancing its ophthalmology pipeline targeting retinal diseases.
Merck’s KEYTRUDA gains EU approval for platinum-resistant ovarian cancer, showing improved survival as the first PD-1 therapy for this group.
Context’s CTIM-76 gains FDA Fast Track for platinum-resistant ovarian cancer, accelerating development of its bispecific antibody therapy.
CellCarta and Pillar Biosciences partner to streamline NGS tumour profiling, enabling faster, cost-efficient, biomarker-driven oncology trials.
Oncotelic and TechForce partner to commercialise AI-powered GMP robotics, enhancing automation, compliance, and efficiency in pharmaceutical manufacturing.
Thermo Fisher launches automated CTS Compleo system to streamline cell therapy fill-finish, reducing variability and improving GMP-compliant manufacturing.
Regeneron partners with TriNetX to integrate genomic and health data, accelerating drug discovery and advancing AI-driven digital health solutions.
Revolution Medicines begins global Phase 3 RASolute 303 trial testing daraxonrasib alone and with chemo for metastatic pancreatic cancer.
FDA approves longer dosing intervals for EYLEA HD, allowing some wet AMD and DME patients to extend treatment to every 20 weeks.
BARDA awards Vericel a 10-year, $197M contract to support NexoBrid supply, emergency readiness, and future development
FDA grants Fast Track status to CDI-988, Cocrystal’s oral antiviral aimed at preventing and treating norovirus infections.
Biodexa teams with Syngene to manufacture MTX240 API and dosage form as it prepares for IND filing and upcoming clinical trials.
BioCardia submits CardiAMP HF trial data to the FDA as it seeks potential accelerated approval for its heart failure therapy.
Annovis Bio secures a U.S. patent for buntanetap to prevent and treat brain injuries caused by infections, strengthening its neurodegenerative drug program.
Revolution Medicines begins global Phase 3 RASolute 303 trial testing daraxonrasib alone and with chemo for metastatic pancreatic cancer
Denali Therapeutics takes full control of DNL593 as Takeda ends collaboration; Phase 1/2 trial results expected by end of 2026, strategic decision not data‑based.
Rhythm Pharmaceuticals welcomes Kim Popovits to its Board as Ed Mathers steps down, bringing decades of life sciences and commercialization expertise
Pharma Now's Voices of Pharma podcast features Shyam Khante (ex-GSK Technical Director) sharing 5 leadership pillars, judgment, urgency, enthusiasm, people care, humor.
Organogenesis confirms FDA Type-B meeting outcome, moving forward with rolling BLA submission for ReNu to treat knee osteoarthritis before December 2026.
Renovare Therapeutics emerges from stealth, partnering with CU Boulder with ARPA-H funding to advance regenerative osteoarthritis therapies and clinical trials.
Silo Pharma announces EPO’s intent to grant a patent for its 5-HT4 agonist approach, targeting stress prevention & resilience through innovative CNS therapies.
Organogenesis to build a $100M facility in Smithfield, RI, boosting wound care and regenerative medicine production and creating over 200 jobs.
Akari Therapeutics forms strategic partnership with WuXi XDC to accelerate development of its PH1 ADC payload, advancing AKTX-101 toward future clinical trials.
Ascendis Pharma receives FDA orphan drug exclusivity for YUVIWEL and makes it commercially available in the U.S., supporting children with achondroplasia.
Avicanna announces John McVicar’s resignation and welcomes Ozgur Kilic to its Board, bringing extensive global pharma and leadership experience to the company.
Neuronetics announces CFO Steven Pfanstiel’s resignation, continuing through May 2026 to ensure a smooth transition and support business continuity.
Chugai and Osaka University identify new ITP subgroup and simple test, enabling targeted treatment with complement inhibitors in blood disorder patients.
IDEAYA enrolls first patient in Phase 1 trial of IDE574, a dual KAT6/7 inhibitor showing strong preclinical anti-tumor activity in solid cancers.
Medicus submits optimized Phase 2 trial design for Teverelix to FDA, targeting the prevention of recurrent urinary retention in BPH patients.
ImmunityBio responds to FDA OPDP concerns, removes podcast, and strengthens compliance for ANKTIVA promotions while clarifying scientific statements.
Praxis reports positive EMBRAVE trial results, with elsunersen showing strong seizure reduction and safety in children with SCN2A epilepsy.
Climb Bio secures FDA Fast Track for budoprutug, an anti-CD19 antibody in development for primary membranous nephropathy, addressing a major unmet medical need.
Corbus gains FDA alignment on the registration path for CRB-701 in head, neck, and cervical cancers, advancing toward late-stage clinical development.
Jupiter Neurosciences adds Kristopher Fishman and Sanjiv Lal to the Nugevia Advisory Board to strengthen strategy in the growing nutraceutical market.
Merakris shows promising MTX-001 results in venous leg ulcers, supporting progression to late-stage trials and potential future FDA approval.
Phase 2 trials show lunsekimig improves asthma and respiratory symptoms with good safety, supporting its potential as a new treatment option.
PathAI teams up with MedStar Health to deploy AI-powered digital pathology, enhancing workflow, accuracy, and diagnostics across its multi-site network
Mesoblast teams with PPMD to support enrollment in an FDA-cleared Ryoncil trial, testing its potential to slow muscle deterioration in children with DMD.
Greenwich LifeSciences files new patent claims for GLSI-100, expanding its potential use in breast cancer and doubling target patient population.
Abeona appoints Keith Goldan to its board as Audit Chair, bringing 20+ years of biotech financial leadership to support strategic growth.
Outlook Therapeutics files a dispute request with the FDA for ONS-5010, aiming to advance approval for an AMD treatment after a prior CRL setback.
Amneal donates $2M to support Parkinson’s patients, improving access to treatment, financial aid, and community awareness during Parkinson’s Awareness Month.
Merck launches tender offer to acquire Terns Pharmaceuticals at $53 per share, with the deal expected to close in Q2 2026, pending approvals.
Plus Therapeutics secures AMA CPT code for CNSide CSF test, supporting reimbursement, adoption, and tracking in CNS cancer diagnostics.
ANI publishes NEW DAY trial results for ILUVIEN in DME, highlighting efficacy and safety risks including cataracts and increased intraocular pressure.
GRI Bio receives a UAE Notice of Allowance for patent covering novel type 2 dNKT cell agonists for inflammatory conditions, strengthening its global IP strategy.
Longeveron secures a new Chinese patent protecting potency assay methods for evaluating mesenchymal stem cells, extending its IP coverage through 2041.
Spectral AI names David McGuire as CFO to strengthen financial leadership ahead of DeepView commercialization and support long-term growth.
RenovoRx receives its first Japanese patent allowance, strengthening protection for the RenovoCath device and its targeted drug-delivery approach.
Remedy Plan Therapeutics appoints Jotin Marango as CFO & CBO to drive financial strategy, growth, and advancement of its clinical oncology initiatives.
Psyence BioMed grows its Australian network from three to five sites to support its ongoing Phase IIb trial of natural psilocybin for Adjustment Disorder.
FDA lifts partial hold on MacroGenics, Inc. Phase 2 LINNET trial, allowing enrollment to resume under an updated safety protocol.
Precision Neuroscience appoints Craig Mermel as Chief AI and Data Officer to lead AI strategy and development of its high-resolution neural dataset.
Kali Therapeutics licenses KT501 to Sanofi in a deal worth up to $1.05B, advancing a tri-specific antibody for autoimmune disease treatment.
GSK’s Exdensur gains China approval for CRSwNP, showing strong Phase III results and offering long-acting relief for patients with uncontrolled disease.
Alkem launches A to Z Daily multivitamin with 26 nutrients and botanicals, supporting energy, immunity, and mental wellness for daily use.
Nxera achieves milestone in Lilly partnership for diabetes drug discovery, advancing GPCR-targeted research and unlocking potential milestone payments.
Telix appoints Maria Rivas and Bill Jellison as Non-Executive Directors to strengthen board leadership and support growth strategy.
Cue Biopharma earns $7.5M milestone from Boehringer Ingelheim, advancing T cell-based therapies targeting autoimmune diseases
FDA grants Orphan Drug status to Plus Therapeutics’ REYOBIQ for pediatric gliomas, supporting development of treatments for rare brain cancers.
ANI launches generic Isosorbide Mononitrate tablets after FDA approval, expanding access to affordable angina treatment options.
Glenmark receives US FDA approval for Progesterone Vaginal Inserts, a generic of Endometrin, targeting a $59.2 million U.S. market segment.
Telix’s Pixclara NDA accepted by US FDA with a PDUFA date of Sept 11, 2026, advancing a PET imaging agent for improved glioma diagnosis.
Amneal launches generic bimatoprost ophthalmic solution 0.01%, equivalent to Lumigan, targeting a $719 million U.S. glaucoma treatment market.
Plus Therapeutics appoints Eric J. Daniels as Chief Development Officer, strengthening leadership with 20+ years of biotech and clinical development expertise.
Zenyaku Kogyo to take full control of Rituxan sales in Japan after ending co-promotion with Chugai Pharmaceutical from September 2026.
EMA allows Wegovy injection storage up to 30°C for 48 hours during delivery, easing logistics and supporting eHealth distribution across Europe.
Novartis expands global programs to improve heart disease and cancer care access, aiming to reach over 30 countries by 2030 with community health initiatives.
Zentalis selects 400mg dose of azenosertib after DENALI results, advancing it toward Phase 3 and potential approval in ovarian cancer treatment
Idorsia names Dr. Amer Joseph as EVP, CMO & Head of Global Clinical Development, succeeding Dr. Alberto Gimona as the company advances its scientific strategy.
Decoy Therapeutics reports major scientific and corporate progress as it advances its multi-antiviral platform toward clinical development
Charles River and the AHA partner to boost national heart-health awareness, prevention efforts and community programs to reduce cardiovascular disease
BioXcel Therapeutics enrolls first patients in DoW-funded Phase 2a trial of BXCL501 for acute stress reactions in collaboration with UNC.
Aravax adds Carsten Hellmann and Andrew Oxtoby to its Board, bringing deep allergy therapeutics expertise to advance its peanut allergy program PVX108.
Thermo Fisher and PRECISE partner to advance SG100K, a major population-scale proteomics study aimed at improving disease insights and precision health.
European Commission approves Dupixent for children 2–11 with chronic spontaneous urticaria, expanding treatment options for uncontrolled CSU.
Nxera Pharma earns $22.5M milestone as Neurocrine starts Phase 2 trial of NBI-1117570 for schizophrenia, advancing new treatment research.
Roche’s Elecsys NfL blood test wins CE mark to detect neuroinflammation in RRMS, enabling easier monitoring of multiple sclerosis disease activity.
NRx Pharmaceuticals appoints Glenn Tyson as its first CCO as it readies key ketamine programs & strengthens commercial strategy for upcoming psychiatric therapies
Oragenics doses the first patient in its Phase IIa trial of ONP-002, an intranasal therapy that aims to become the first drug treatment for concussion and mTBI.
Regeneron & Telix form a partnership to develop next-gen radiopharmaceutical cancer therapies, combining antibody expertise with advanced radiopharma capabilities.
Spyre Therapeutics reports positive 12-week Phase 2 SKYLINE data for SPY001, showing strong potential as a best-in-class treatment for moderate-to-severe UC.
ALX Oncology appoints Jeff Knight as Chief Development and Operating Officer to lead clinical development and support upcoming oncology program milestones.
Epitopea adds expert Lisa Butterfield to its Scientific Advisory Board as it advances RNA-based cancer therapies, including its lead program CryptiVax-1001.
Kymera Therapeutics receives FDA Fast Track designation for KT-621, an oral STAT6 degrader in Phase 2b trials for moderate to severe eosinophilic asthma.
Geron appoints Timothy Williams as EVP, Chief Legal Officer, & Corporate Secretary, adding key legal & leadership expertise to support its hematology strategy.
Enhanced Compliance Inc appoints Khalid Raja as SVP to drive strategic growth, bringing 30+ years of quality and regulatory leadership in life sciences.
GSK reports strong Phase I results for Mo-Rez ADC, showing up to 67% response in ovarian and endometrial cancers, advancing to Phase III trials.
Neuronetics expands access to TMS therapy as Optum updates policy allowing nurse practitioners to deliver NeuroStar treatment for depression.
Thermo Fisher partners with HealthVerity to access 270M patient data, enhancing AI-driven clinical trials and real-world evidence generation.
FDA grants Priority Review to Daiichi Sankyo and Merck’s lung cancer drug ifinatamab deruxtecan, with decision expected by October 2026.
Enanta doses first patient in Phase 1 trial of EDP-978, an oral KIT inhibitor for urticaria, evaluating safety, PK, and PD in healthy volunteers.
ANI Pharmaceuticals launches generic carbamazepine extended-release capsules, targeting a $65 million U.S. market for neurological treatments.
IDEAYA and Servier report strong Phase 2/3 results for darovasertib combo in uveal melanoma, showing improved PFS and response rates.
Novo Nordisk partners with OpenAI to use AI in drug discovery, manufacturing, and operations, aiming to accelerate innovation and improve patient outcomes.
FDA warns Dry Springs Pharmacy over unapproved, misbranded online drug sales. What manufacturers and compounders must know about compliance.
Sun Pharma's 116-product generic pipeline and API growth raise manufacturing capacity and USFDA compliance questions for the industry.
Hormuz corridor tensions drive up pharma raw material costs. Indian MSMEs face price spikes on key inputs. What plant heads and QA teams need to know.
Structure Therapeutics Inc. appoints Matthew Lang as COO to support aleniglipron obesity drug as it moves into Phase 3 trials.
Telix Pharmaceuticals Limited doses first patient with TLX101-Tx for recurrent glioblastoma in Phase 3 IPAX BrIGHT trial.
Tempest Therapeutics, Inc. appoints Andrew Fang to drive amezalpat hepatocellular carcinoma partnerships and support China Phase 3 expansion.
Zealand Pharma A/S appoints Eric Rojas as VP of Investor Relations to support pipeline growth and U.S. expansion strategy.
Rivus Pharmaceuticals Inc. begins HU6 Phase 2 AMPLIFY trial dosing for MASH to evaluate liver fat reduction and metabolic outcomes.
Culture Biosciences appoints Mike Stapleton to Board to scale Stratyx hardware and Console SaaS platform for bioprocess development.
Neion Bio appoints James Kehler as Head of Avian Sciences to advance genome engineering for biologics production.
Sandoz signs deal with Rwanda to supply essential medicines and antibiotics, expanding access across African countries.
Aligos Therapeutics reports Phase 2 data and gains FDA Fast Track for pevifoscorvir in chronic hepatitis B.
Amneal Pharmaceuticals launches generic albuterol and beclomethasone inhalers in the U.S. for asthma and bronchospasm treatment.
Praxis Precision Medicines gains FDA NDA acceptance for ulixacaltamide in essential tremor with PDUFA decision in January 2027.
Avantor, Inc. signs exclusive deal to distribute Parafilm M in India, expanding lab sealing and contamination control solutions.
Nxera Pharma gains Taiwan approval for QUVIVIQ insomnia drug through partner Holling Bio-Pharma, with launch planned in 2026.
Clearmind Medicine moves CMND-100 into cohort 4 for alcohol use disorder after positive Phase I/IIa safety review with no serious adverse events reported.
NeuraClick appoints Dr. Gavin Dawe and Dr. Tomi Sawyer to support neuropeptide platform and CNS drug development strategy.
Neutrolis appoints Caren Deardorf as Chief Business and Strategy Officer to drive pipeline strategy and growth in autoimmune and inflammatory disease programs.
Nkarta gains FDA alignment to expand NKX019 trials, enabling outpatient dosing and broader patient access in autoimmune disease studies.
Tango Therapeutics adds leadership to advance vopimetostat for pancreatic cancer and support late-stage development and potential approval.
ARS Pharmaceuticals wins Health Canada approval for neffy to treat anaphylaxis, expanding needle-free emergency allergy care in Canada.
Prelude Therapeutics appoints Charles Morris as Chief Medical Officer to lead oncology pipeline and clinical development strategy.
Plus Therapeutics appoints Randy Goodman as VP HEOR to lead value strategy and market access for CNS oncology portfolio including CNSide and REYOBIQ.
Achieve Life Sciences advances cytisinicline manufacturing with Adare and plans NDA resubmission in 2026 for nicotine dependence treatment.
Dogwood Therapeutics gains FDA IND approval for SP16 to treat chemotherapy-induced neuropathy and plans Phase 1b trial in 2026.
Medix Biochemica appoints Petra Furu as CEO to lead growth strategy and expand its IVD business globally.
FDA warns ybycmeds for misbranding compounded semaglutide and tirzepatide products. Section 502 violations cited for claims of similarity to Ozempic and Mounjaro.
FDA warns Tuyo Health over misleading compounded semaglutide and tirzepatide claims. What 503A/503B compounders need to know about FDCA 502(a) compliance.
FDA warning letter to Sprout Health cites misbranding of compounded semaglutide and tirzepatide. What compounding QA teams need to know now.
FDA's FAERS upgrade to ICH E2B(R3) standards requires pharma teams to update ICSR submission systems. Review draft business rules and technical specs.
Cochrane Collaboration review finds amyloid-targeting Alzheimer's therapies lack meaningful clinical benefit, raising FDA/EMA regulatory implications.
FDA clears Alembic Pharmaceuticals' ANDA for Methotrexate Injection. Analysis of sterile injectable compliance, ANDA review timelines, and supply impact.
UAlbany develops laser-based non-destructive method for mRNA vaccine characterization with potential GMP release testing applications.
NPA survey reveals fake weight-loss injections reached UK consumers. What GMP manufacturers and QA teams need to know about serialization and supply chain gaps.
Cumberland Pharmaceuticals wins expanded FDA indication for Caldolor IV ibuprofen. What hospital formulary and QA teams need to know about the label change.
Aerska appoints Stuart Milstein to advance RNAi platform for CNS diseases toward clinical development.
Arbutus Biopharma Corporation wins FDA Fast Track for imdusiran in chronic hepatitis B, aiming to speed development of this investigational therapy.
Immutep Limited gains FDA Orphan Drug status for eftilagimod alfa in soft tissue sarcoma, supporting its immunotherapy development in rare cancer.
MinervaX ApS appoints new leaders to advance its GBS vaccine into late-stage trials for preventing Group B Streptococcus infections.
PacBio and Covaris launch FFPE workflow for HiFi cancer sequencing, improving variant detection from archived tissue samples.
FDA generic drug review times fell from 35.93 to 32.82 months in FY 2026. First-cycle approvals reached 80 through April. Analysis for generic manufacturers.
Medera's FDA Fast Track for low-dose AAV-SERCA2a gene therapy in DMD cardiomyopathy raises CMO batch release and potency assay readiness questions.
Achieve Life Sciences appoints Andrew Goldberg, MD, as CEO with $354M financing ahead of potential FDA approval of cytisinicline for nicotine dependence.
Xilio Therapeutics presents preclinical data for XTX601, a masked T cell engager targeting CLDN18.2, showing tumor-selective activation and NHP tolerability.
ARS Pharma's neffy approval highlights GMP manufacturing and 505(b)(2) regulatory challenges for drug delivery reformulations targeting line extensions.
Merck shares PD-1xVEGF bispecific data in NSCLC but holds back on phase 3 plans. What this means for GMP manufacturing and facility investment.
Oral biologics and macrocycle drugs from J&J and Merck are reshaping pharma manufacturing. What plant heads and QA directors need to know.
Sanofi's COMPARE study shows Nuvaxovid has statistically lower reactogenicity than Moderna's mNEXSPIKE across all endpoints in 1,000 US adults.
Aurobindo Pharma gets USFDA nod for Glycerol Phenylbutyrate Oral Liquid, a generic Ravicti for urea cycle disorders. Impact on pricing and supply.
PGI Chandigarh resumes bariatric surgery in 2025 with three sleeve gastrectomies after zero cases in 2024, as weight-loss injections reshape obesity care.
Updated zongertinib trial data in frontline HER2-mutated NSCLC signal manufacturing scale-up, process validation, and GMP readiness demands.
Ministry of Health and OECS host antimicrobial stewardship workshop to strengthen responsible medicine use across the Eastern Caribbean region.
Health Canada approved Biocon's Bosaya and Vevzuo denosumab biosimilars on April 3, 2026, covering osteoporosis and oncology bone indications across two dosing presentations.
BioMed X establishes an AI-driven bispecific antibody research team in France under immunologist Tomabu Adjobimey, signaling a shift in biologics discovery strategy.
Allogene publishes preclinical data on an allogeneic BCMA/CD70 dual CAR T program for high-risk multiple myeloma. Key implications for GMP manufacturing and regulatory strategy.
FDA accepts Roche's sBLA for obinutuzumab (Gazyva) in SLE based on ALLEGORY phase III data. Decision expected December 2026. Key GMP and regulatory implications.
Eli Lilly's $7B acquisition of Kelonia Therapeutics signals a shift in ATMP manufacturing strategy with major implications for CDMOs and in vivo CAR-T GMP.
Merck's pumitamig update at AACR 2026 re-enters the PD-pathway race. What it means for CMC, process validation, and late-stage oncology manufacturing strategy.
CDSCO replaces approval requirements for early drug testing with a digital prior intimation system on the NSWS portal. Key implications for pharma and CDMOs.
Eupraxia's EP-104GI shows 90% tissue score reduction and 66% remission at 36 weeks in EoE highest dose cohort. No drug-related SAEs across 31 patients.
Eli Lilly CEO David Ricks frames GLP-1 drugs as a statin-scale opportunity. Here is what the demand debate means for manufacturing capacity and supply chain planning.
Proposed Pharmaceutical Affairs Act revisions in Asia would extend government supply authority to nonessential drugs. Public comment closes June 10. Key implications for multinational pharma.
Galux and GC Biopharma partner on AI antibody drug discovery. What it means for GMP manufacturers, QA directors, and regulatory affairs teams preparing for novel biologics.
Isosceles Pharmaceuticals doses first patient in IPI201 Phase I trial. What QA and CMC teams need to know about manufacturing readiness implications.
The MHRA has recalled a Ramipril batch due to a manufacturing error. QA directors should review batch release controls and deviation management processes now.
Allogene expands its Phase 2 ALPHA3 trial to South Korea and Australia, raising key questions about allogeneic cell therapy CMC readiness and BLA filing strategy.
FDA's OGD has redesigned GDUFA III pre-submission meetings to reduce ANDA risk. Learn what changed, who is affected, and how to prepare a meeting request.
Roche's fenebrutinib reduced MS relapse rates by up to 58.5% vs teriflunomide in Phase III. A combined RMS and PPMS regulatory submission is now confirmed.
FDA opens PreCheck Pilot applications February 1, 2026. Learn how early GMP facility assessments will reshape domestic manufacturing timelines and inspection strategy.
ProBioGen names Dr. Simon Johannes Bulling COO. His dual drug substance and drug product background has direct implications for CDMO GMP and process validation.
FDA's SrLC database tracks NDA and BLA safety labeling changes since 2016. Learn how regulatory affairs teams can use it for proactive postmarket compliance.
FDA grants priority review approval for Sanofi's Tzield sBLA, expanding the pediatric T1D indication to children as young as one year, backed by phase 4 PK data.
FDA extends Sarclisa SC BLA review up to three months to July 23, 2026. The on-body injector filing signals growing regulatory complexity for oncology combination products.
Ipsen's tovorafenib receives EU conditional marketing authorization as the first targeted therapy for relapsed or refractory pLGG, based on Phase II FIREFLY-1 data.
Asahi Kasei completes Aicuris acquisition to build a global specialty pharma platform focused on severe infectious diseases. GMP and regulatory implications examined.
Merck wins FDA priority review for KEYTRUDA and KEYTRUDA QLEX plus Padcev in bladder cancer. Key implications for biologics manufacturing and GMP compliance.
Leinco and CellCarta partner on integrated proteomics for biomarker discovery in oncology. What it means for analytical testing and GMP compliance in drug development.
Supriya Lifescience receives USFDA EIR with VAI classification for its Maharashtra API facility, maintaining GMP compliance and U.S. market supply eligibility.
Adial Pharmaceuticals confirms AD04 demonstration batch met dissolution, blend, and content uniformity specs, enabling Phase 3 clinical and registration production.
Capricor's HOPE-3 Phase 3 DMD results presented at AAN 2026. With a PDUFA date of August 22, 2026, allogeneic CDC manufacturing and CDMO capacity face new scrutiny.
Moderna's EU approval for the first combined flu/COVID mRNA vaccine sets a CMC and batch release benchmark for manufacturers developing combination vaccine pipelines.
AstraZeneca's Ultomiris posts strong Phase III interim results in IgA nephropathy. What this means for complement inhibitor manufacturing capacity and GMP planning.
Roche's ENSPRYNG cuts MOGAD relapse risk 68% in Phase III METEOROID trial. QA and regulatory teams should prepare for BLA/MAA filings and CMC requirements.
AbbVie's $1.4B Durham, NC campus will anchor U.S. SVP sterile injectable manufacturing with AI-integrated GMP operations. Construction starts 2026, completion 2028.
George Medicines' TRIDENT trial shows GMRx2 fixed-dose triple combination reduced recurrent stroke by 39% in ICH survivors. NEJM publication, April 2026.
Inventiva appoints CFO, CLO, and CPO ahead of NATiV3 Phase 3 lanifibranor data in Q4 2026, signaling regulatory and commercial readiness in the MASH pipeline.
FDA approves Dupixent for CSU in children aged 2-11 via efficacy extrapolation and PK bridging. A regulatory pathway model for future pediatric biologic submissions.
FDA's GDUFA III DMF prior assessment process allows Type II API DMF holders to request review 6 months before ANDA submission. Key details for regulatory teams.
Orion Pharma initiates TEADCO Phase 1b/2 basket trial evaluating ODM-212 pan-TEAD inhibitor in mesothelioma, KRAS G12C NSCLC, and pancreatic cancer combinations.
Sanofi's Q1 2026 results include five immunology approvals, Dupixent at €4.2B, and the Dynavax close. Here's what it means for manufacturing and GMP compliance.
Roche's Q1 2026 Phase III fenebrutinib and Phase II petrelintide data advance toward commercial scale, pressing CMOs on process validation and supply readiness.
Ipsen withdraws Tazverik on safety signals, posts 22.6% CER sales growth in Q1 2026, and targets three Phase III readouts in H2 2026. Key implications for QA and manufacturing.
Plus Therapeutics activates SpectronRx as a second GMP site for REYOBIQ, advancing a dual-site radiopharmaceutical supply chain ahead of pivotal trials.
Novo Nordisk's PIONEER TEENS Phase 3a trial meets primary endpoint in youth aged 10-17. US and EU label expansion filings for oral semaglutide planned H2 2026.
Greenwich LifeSciences FLAMINGO-01 interim data shows 70-80% recurrence reduction. What do CMC and process validation teams need to know about GLSI-100 scale-up?
WHO certifies the Bahamas for eliminating mother-to-child HIV transmission, meeting strict antenatal coverage and transmission rate thresholds under its MCH programme.
WHO's 2025 Results Report shows Triple Billion progress but flags funding constraints, missed output indicators, and SDG timelines at risk by 2030.
Regeneron's White House agreement links Medicaid and future U.S. drug prices to developed-country benchmarks, with Otarmeni gene therapy offered free domestically.
Regeneron's Otarmeni receives FDA accelerated approval as the first gene therapy for OTOF-related hearing loss, with 80% of CHORD trial participants meeting the primary endpoint.
Dogwood Therapeutics transfers antiviral assets IMC-1 and IMC-2 to PRIDCor Therapeutics in a deal capped at $100M, refocusing on Halneuron and SP16 for pain.
PridCor Therapeutics acquires Phase 3-ready IMC-1 and Phase 2b-ready IMC-2, targeting Long COVID and infection-associated chronic illness via viral reactivation.
J&J's 120-week nipocalimab OLE data in gMG shows sustained IgG reduction and symptom control, with regulatory and lifecycle management implications for FcRn blockers.
Lupin enters the US generic SGLT2 market with FDA-approved Dapagliflozin/Metformin ER Tablets, bioequivalent to AstraZeneca's Xigduo XR. Key implications for generics manufacturers.
Neuland Laboratories reports rising peptide engagements from Japanese pharma at preclinical stages, signalling a structural shift in CDMO outsourcing strategy.
CDER approved 46 novel drugs in 2025 across oncology, rare disease, and biologics. Here is what CDMOs and QA directors need to know about manufacturing and GMP implications.
FDA's Drug Trials Snapshots program documents trial demographics for NMEs and biologics. What QA and regulatory teams must monitor in new approval packages.
FDA approved Entasis Therapeutics' NUZOLVENCE (zoliflodacin) for gonorrhea in Dec. 2025 via a single Phase 3 trial. Key implications for anti-infective regulatory strategy.
FDA approves Regeneron's Otarmeni under CNPV in 61 days, the first dual-vector AAV gene therapy cleared via the pilot. Key implications for BLA and CMC strategy.
CLINUVEL receives final EMA scientific advice for its pivotal Phase III vitiligo study. Key implications for regulatory affairs teams planning pivotal trial design.
Clariant extends continuous strip desiccant reel production to the Americas. QA teams must evaluate GMP supplier qualification implications for pharma packagers.
Novo Nordisk's oral semaglutide shows superior HbA1c reduction in pediatric type 2 diabetes. What plant heads and CMOs must prepare for now.
Novartis secures WHO prequalification for Coartem Baby, the first artemether-lumefantrine formulation for infants 2-5 kg, opening public sector procurement pathways.
Health Canada approves Biocon's Bosaya and Vevzuo as denosumab biosimilars to Prolia and Xgeva, with implications for GMP, biosimilar market access, and regulatory strategy.
EMA's CHMP recommended five medicines in April 2026, including a gene therapy for SMA and a biosimilar for eye disease, plus nine indication extensions.
EMA's CHMP recommends EU approval for plozasiran (Redemplo) in FCS without genetic testing requirement. Key implications for rare disease regulatory strategy.
Gujarat Themis Biosyn acquires 13 Sanofi anti-TB and anti-infective brands across 55+ markets for EUR 158M, triggering complex GMP and regulatory transfer obligations.
CHMP backs Novartis Itvisma for SMA patients aged 2 and older. Fixed-dose intrathecal gene therapy raises GMP and CMC strategy questions ahead of EC decision.
Sanofi's Cenrifki receives CHMP positive opinion for non-relapsing SPMS. DILI risk flags strict liver monitoring requirements for EU regulatory and QA teams.
Merck's $1B agentic AI deal with Google Cloud spans manufacturing and R&D. QA and regulatory teams must now address GMP validation and data integrity implications.
ModeX doses first patients with MDX2003 T-cell engager for B-cell lymphoma, raising CMC, process validation, and regulatory complexity for multi-specific biologics.
WHO validates Algeria as trachoma-free, the 29th country globally. Learn how the SAFE strategy and national health infrastructure drove elimination.
WHO, Gavi, and UNICEF confirm 100M+ BCU doses across 36 countries. What it means for cold chain capacity, fill-finish demand, and vaccine procurement forecasting.
Eton Pharmaceuticals appoints Judith M. Matthews as CFO. The specialty pharma firm signals continued investment in pipeline development and regulatory strategy.
Roche and Zealand Pharma's amylin weight-loss candidate signals growing CDMO demand. Plant heads must assess sterile manufacturing and process validation capacity now.
Novartis clears WHO prequalification for a pediatric three-drug fixed-dose combination antimalarial, setting new GMP and formulation benchmarks for CMOs in global health supply chains.
Sun Pharma's $11.75B acquisition of Organon expands biosimilars and women's health scale. Key GMP, ICH Q10, and regulatory harmonization implications for plant and QA teams.
Alembic Pharmaceuticals secures FDA final approval for Fingolimod 0.5 mg capsules, a generic to Novartis Gilenya. Key ANDA and GMP implications for MS generics manufacturers.
Novartis secures EC approval for Rhapsido (remibrutinib) as the first oral targeted CSU therapy in Europe. Key implications for QA, regulatory, and manufacturing teams.
Zydus secures DCGI approval for Phase III trials of oral anti-malarial Zintrodiazine. What RA teams and QA directors need to know about multi-centre compliance.
Eton Pharmaceuticals doses first patient in ET-700 pilot trial testing extended-release zinc acetate for Wilson disease. Topline data expected H2 2026.
Medicus Pharma met with House Energy and Commerce leaders to advance Orphan Drug Designation and registrational IND approval for SkinJect in Gorlin Syndrome.
Cipla wins USFDA approval for the first AB-rated generic of Ventolin HFA, advancing Indian pharma competitiveness in complex inhaler generics.
Former Cipla MD Umang Vohra appointed Executive Chairman and Group CEO of Cohance Lifesciences as Vivek Sharma moves to advisory role.
Sionna Therapeutics completes PreciSION CF Phase 2a enrollment for SION-719, the first NBD1 stabilizer in clinical CF trials. Topline data expected summer 2026.