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1,014 stories matching this filter · ← front page

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  • European pharma CEOs warn of biotech decline as R&D share drops to 31% and call for faster trials and stronger IP protection
    Nine leading European pharma board chairs issued an open letter warning that Europe is losing its biotech edge. They note that Europe's share of global pharma R&D fell from 43% in 1990 to 31% toda…
    BioPharma Dive · 27d agoNegative↗ source
  • FDA issues early alert on React Health VOCSN ventilators over connector fault
    The FDA's Center for Devices and Radiological Health has posted an early alert about a potential high‑risk problem with certain VOCSN ventilator units made by Ventec Life Systems, operating as Reac…
    fda medwatch · 27d agoRegulatoryNeutral↗ source
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  • AI-driven biotech Enveda secures $311 million Series E to advance plant-derived drug candidates
    Enveda Biosciences, a Colorado AI drug discovery company, announced a $311 million Series E financing round, one of the larger biotech raises this year. The firm uses artificial intelligence to sc…
    BioPharma Dive · 27d agoDealPositive↗ source
  • FDA issues early alert on Abiomed Impella controller safety issue
    The FDA Center for Devices and Radiological Health (CDRH) has posted an Early Alert about a potential high risk problem with certain Abiomed Impella automated controllers. Abiomed has sent a lette…
    fda medwatch · 27d agoRegulatoryNegative↗ source
  • Industry groups back FDA’s proposed distributed manufacturing rule, seek clarification on implementation
    Industry trade groups have expressed overall support for the FDA’s draft rule that would allow drugs to be produced using distributed manufacturing models. The proposal aims to modernize the supply…
    raps · 27d agoRegulatoryNeutral↗ source
  • Berlin Seeds recalls 950 lbs of alfalfa sprouting seed over possible STEC and Salmonella contamination
    Berlin Seeds of Millersburg, Ohio announced a recall of 950 pounds of its alfalfa sprouting seed. The recall was triggered because the seed could be contaminated with Shiga toxin‑producing Escheri…
    fda recalls · 26d agoRegulatoryNegative↗ source
  • Amgen's Dazodalibep Shows Positive Results in First Phase 3 Trial for Sjögren’s Syndrome
    Amgen announced that its experimental drug dazodalibep, acquired through the Horizon Therapeutics acquisition, met the primary endpoint in the first of two Phase 3 trials for Sjögren’s syndrome, a…
    BioPharma Dive · 28d agoPositive readoutPositive↗ source
  • Celldex shares drop as Phase 3 data for barzolvolimab show efficacy but raise anaphylaxis safety concerns
    Celldex reported Phase 3 results for barzolvolimab in chronic spontaneous urticaria, showing strong efficacy against hives and itching. Two cases of life-threatening anaphylaxis were observed amon…
    BioPharma Dive · 28d agoNegative readoutNegative↗ source
  • Alkermes reports early proof-of-concept for orexin-2 drug in ADHD
    Alkermes announced early-stage trial results for ALKS 7290, an orexin‑2 receptor agonist originally being developed for narcolepsy, showing proof of concept in ADHD. The study reported dose‑depend…
    BioPharma Dive · 28d agoPositive readoutPositive↗ source
  • Consumer groups call on FDA to strengthen generic drug testing and safety reporting under GDUFA IV
    Consumer health organizations used a public meeting on the reauthorization of the Generic Drug User Fee Amendments to press the FDA for more resources dedicated to testing generic medicines. The g…
    raps · 28d agoRegulatoryNegative↗ source
  • Viking Therapeutics reports obesity drug maintains weight loss after dosing switch, shares jump 36%
    Viking Therapeutics said its Phase 2 trial of the dual-acting obesity candidate VK2735 showed participants largely kept the weight they had lost when the dosing schedule changed from a weekly injec…
    BioPharma Dive · 28d agoPositive readoutPositive↗ source
  • Trump administration’s MFN drug pricing deals may cut projected Medicare savings by up to 80%
    The White House announced "most-favored-nation" pricing agreements with 26 pharmaceutical companies, saying the contracts would lower drug costs for federal programs. The deals require companies to…
    BioPharma Dive · 28d agoRegulatoryNegative↗ source
  • Regulators Share Guidance for Effective Sponsor Meetings
    Regulators from the U.S. FDA, the U.K. MHRA and other European agencies met to outline best practices for sponsor‑regulator interactions. They highlighted that transparency, open collaboration, at…
    raps · 28d agoRegulatoryNeutral↗ source
  • Global regulators must align on new approach methodologies to give sponsors certainty
    New approach methodologies, or NAMs, are being promoted as ways to reduce reliance on animal testing in drug development. They promise faster, more humane studies while still providing safety data.…
    raps · 28d agoRegulatoryNeutral↗ source
  • Pharma firms ask Trump admin to safeguard China partnerships as EU pushes for quicker trials and higher spending
    Pharma companies in the United States are urging the Trump administration to take steps that would protect their existing and future business arrangements with Chinese partners. At the same time,…
    raps · 28d agoRegulatoryNeutral↗ source
  • Telix to acquire Germany's ITM for $1.65 billion, aiming to dominate radiopharmaceutical market
    Telix, an Australian radiopharmaceutical diagnostics company, announced it will purchase German developer ITM in a cash transaction valued at $1.65 billion upfront. The agreement gives Telix the o…
    BioPharma Dive · 29d agoDealPositive↗ source
  • Global Mix Inc. recalls Niwali Tejocote supplements after FDA finds toxic yellow oleander content
    Global Mix Inc., based in Middle Village, New York, announced a recall of its Niwali Tejocote Capsules and Pieces, both marketed as herbal dietary supplements. The FDA’s analysis indicated the pro…
    fda recalls · 29d agoRegulatoryNegative↗ source
  • Novo outlines plan for multiple new drugs to regain market share as shares dip 8%
    At a capital markets day in London, Novo executives presented a roadmap to launch more than five multi-blockbuster drugs by 2030 and target $23 billion in annual sales by 2035, aiming to offset the…
    BioPharma Dive · 29d agoNegative↗ source
  • Walgreens Specialty Pharmacy highlights holistic support to boost oncology medication adherence
    Advances in oncology are moving care out of the clinic and into patients' homes, with treatments becoming more personalized. This shift means patients often manage complex drug schedules themselves…
    BioPharma Dive · 29d agoPositive↗ source
  • Healthcare systems lag behind rapid expansion of GLP-1 therapies, raising care and trust challenges
    GLP-1 drugs have demonstrated that pharmacological treatment can effectively reduce obesity, and regulators have now approved them for additional uses such as cardiovascular risk reduction, metabol…
    BioPharma Dive · 29d agoNeutral↗ source
  • Par Health recalls two lots of dexmedetomidine infusion due to particulate contamination
    Par Health announced a voluntary recall of two lots of its dexmedetomidine HCl in 0.9% sodium chloride injection, which is used for intravenous sedation. The recall was initiated after testing ide…
    fda medwatch · 29d agoCRLNegative↗ source
  • Otsuka ICU Medical recalls one lot of 0.9% Sodium Chloride injection after possible potassium chloride mix-up
    Otsuka ICU Medical LLC announced a voluntary recall of a single lot of its 0.9% Sodium Chloride Injection, USP, 100 mL. The recall was triggered after a customer complaint revealed that the overwr…
    fda medwatch · 29d agoRegulatoryNegative↗ source
  • CooperSurgical issues recall of INCA infant nasal CPAP sets over loose connection risk
    CooperSurgical has announced a recall of its INCA infant nasal CPAP complete and replacement sets. The recall is due to a potential loose connection between the flexible tubing and the nasal cannu…
    fda medwatch · 29d agoCRLNegative↗ source
  • Regulators call for unified AI guidelines in drug development at RAPS Convergence 2026
    Regulators and industry experts gathered at RAPS Convergence 2026 in Charlotte, NC to discuss the growing role of artificial intelligence in drug development. The panel highlighted that differing…
    raps · 29d agoRegulatoryNeutral↗ source
  • FDA staff flag no major concerns for Grail's multi-cancer test ahead of advisory committee
    FDA staff have completed a review of Grail's multi-cancer early detection test and reported no major concerns. The assessment comes as the test approaches a scheduled advisory committee meeting, w…
    raps · 29d agoRegulatoryNeutral↗ source