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644 stories matching this filter · ← front page

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  • TRex Bio prices $117M IPO to fund Treg-targeted immune therapies
    TRex Bio announced pricing of its initial public offering at $117 million, selling 8,333,334 shares at $14 each, meeting the low end of its earlier guidance. The company will begin trading on Nasd…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • FDA issues early alert on Philips Lumify ultrasound system software and connection problems
    The FDA’s Center for Devices and Radiological Health has released an Early Alert about a potential high‑risk issue with Philips Lumify diagnostic ultrasound devices. The problem involves either a s…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
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  • Argenx shares tumble 15% after Phase 3 Sjögren’s study of Vyvgart halted for futility
    Argenx reported that an independent monitoring board recommended stopping its Phase 3 trial of Vyvgart in Sjögren’s disease due to futility, based on an interim analysis. The decision came earlier…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Viatris to acquire Pacira BioSciences for $1.65 billion, adding two non-opioid pain drugs
    Viatris announced Thursday it will purchase Pacira BioSciences for $1.65 billion in cash, paying $36.50 per share, a 45% premium to the prior close. The acquisition gives Viatris control of Pacira…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Caribou Biosciences explores strategic alternatives, drawing interest as a reverse-merger candidate
    Caribou Biosciences, the cell‑therapy company co‑founded by CRISPR pioneer Jennifer Doudna, announced it is evaluating strategic alternatives as it faces a difficult financing environment. The com…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • HHS unveils new vaccine injury surveillance plan with NIH clinic and reporting reimbursements
    The Department of Health and Human Services announced a comprehensive initiative to improve monitoring of vaccine-related injuries. The plan includes opening a new clinic at the National Institute…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Caribou Biosciences halts CAR-T programs and cuts staff amid funding shortfall
    Caribou Biosciences, a CRISPR gene-editing company co-founded by Nobel laureate Jennifer Doudna, announced it will stop work on its off-the-shelf CAR-T cancer therapies. The decision follows the c…
    BioPharma Dive · 1mo agoLayoffsNegative↗ source
  • Cerevance reports positive Phase 3 results for Parkinson’s drug solengepras
    Cerevance, a Boston biotech spinout from Takeda, announced that its experimental Parkinson’s drug solengepras achieved its primary endpoint in a Phase 3 trial. The trial enrolled 341 patients with…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Dutch court blocks Merck's subcutaneous Keytruda sales in eight European countries after Halozyme patent win
    A Netherlands court issued an injunction that stops Merck from marketing its subcutaneous formulation of Keytruda, known as Keytruda Qlex, in eight European markets. The ruling follows a patent in…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • AbbVie/Genmab’s Epkinly halves progression risk in frontline DLBCL trial
    A Phase 3 study of the bispecific antibody Epkinly combined with standard chemotherapy showed nearly a 50% reduction in the risk of disease progression or death compared with chemotherapy alone in…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • GE HealthCare to buy Sofie Biosciences for $945 million, boosting U.S. PET radiopharma capacity
    GE HealthCare announced it will acquire Sofie Biosciences for $945 million in cash, aiming to broaden its radiopharmaceutical manufacturing and distribution in the United States. Sofie Biosciences…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Forbion raises $2.6 billion for two European biotech venture funds
    Forbion announced it has secured 2.3 billion euros ($2.6 billion) across two new venture funds, its largest raise to date. The funds, called Forbion Growth Opportunities IV and Forbion Ventures Fu…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • ArriVent shares tumble as lung cancer trial of furmonertinib misses primary goal
    ArriVent BioPharma reported that its late-stage study of furmonertinib in patients with EGFR exon 20 insertion-mutated non-small cell lung cancer did not achieve its primary endpoint. The trial, w…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Nova Biomedical issues global correction for StatStrip Glucose Hospital Meter over software patient-ID error
    Nova Biomedical announced a global medical device correction for its StatStrip Glucose Hospital Meter System. The correction targets a software issue in the Gen 2.0 model that can leave prior pati…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Key Biopharma Conferences to Watch in 2027 Highlight Industry Trends
    The article lists major medical meetings slated for 2027 that serve as platforms for companies to present clinical data and network. Highlights include the J.P. Morgan Healthcare Conference in ear…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Season 2 of The Progress Profile podcast spotlights Alzheimer’s research and patient-centered trial design
    The Progress Profile: Alzheimer’s Research in Focus returns for a second season, offering conversations about Alzheimer’s disease and brain health. In the premiere episode, Dr. John Harrison, Dr.…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Vaxcyte's next-gen pneumococcal vaccine matches leading shots in Phase 3 trial
    Vaxcyte reported that its experimental pneumococcal vaccine, VAX-31, achieved its primary efficacy goals in the first of three Phase 3 studies. In adults aged 50 and older, the vaccine performed o…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Nobel Prize honors optogenetics pioneers; Roche licenses Alector’s Parkinson’s enzyme therapy
    The Nobel Committee awarded this year’s Physiology or Medicine prize to three scientists whose work created the field of optogenetics. Their discoveries of a light‑sensing protein in algae and its…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Shionogi to acquire Texas-based IntraBio for $2 billion, adding marketed rare-disease drug Aqneursa
    Shionogi announced Monday it will buy IntraBio, a Texas biotech, for $2 billion in cash, making IntraBio a wholly owned subsidiary of its U.S. division. The deal gives Shionogi ownership of Aqneur…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • AI drives faster drug development and reshapes biopharma manufacturing facilities
    AI is speeding up the identification of drug candidates, turning years of laboratory work into months by analyzing large biological datasets and accelerating early‑stage development. This accelera…
    BioPharma Dive · 1mo agoPositive↗ source
  • Diagnostic-driven therapies face patient loss due to workflow gaps, new commercialization model proposed
    The sponsored article from Diaceutics highlights that while diagnostic-driven therapies are being developed faster than ever, many patients who could benefit never receive them. The authors attribu…
    BioPharma Dive · 1mo agoNeutral↗ source
  • ICU Medical updates IV tubing set instructions after reports of black specks in drip chambers
    ICU Medical has issued a final update letter recommending revised use instructions for several of its IV tubing sets after reports of black specks and particulate matter in the drip chambers. The…
    fda medwatch · 1mo agoRegulatoryNeutral↗ source
  • Novartis pays $575 million upfront for access to Chinese biotech Abogen’s RNA platform and option on ABO-2203
    Novartis announced a deal with China‑based Abogen Biosciences that could be worth up to $7.8 billion. The agreement includes an upfront payment of $575 million. Under the deal, Abogen will provide…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Kodiak Sciences' Zenkuda shows non-inferior six-month dosing vs Eylea, shares double
    Four years ago Kodiak Sciences saw its share price plunge about 80% after its lead eye-disease candidate failed a head-to-head trial against Regeneron's Eylea, wiping out roughly $2 billion in mark…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Draeger recalls VentStar Resus Neo hoses over crack risk
    Draeger has issued a Class I recall for its VentStar Resus Neo breathing circuit hoses after discovering that some hoses can develop cracks or become detached. The company sent a letter to custome…
    fda medwatch · 1mo agoCRLNegative↗ source