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1,302 stories matching this filter · ← front page

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  • GSK to cut up to 1,217 jobs in Belgium as cost-saving plan accelerates
    GSK announced it will lay off up to 1,217 employees in Belgium as part of its global cost-saving program. The cuts will affect R&D, manufacturing and support functions across the company's three m…
    Fierce Biotech · 6d agoLayoffsNegative↗ source
  • Agilent to acquire digital pathology software firm Proscia for $240 million upfront
    Agilent Technologies announced an all‑cash acquisition of Proscia, a digital pathology software specialist, for $240 million upfront with up to $30 million in milestone payments. The deal gives Ag…
    Fierce Biotech · 6d agoDealPositive↗ source
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  • UK regulator MHRA unveils multi-year plan to speed AI-driven drug oversight
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released a multi-year strategy aimed at keeping its regulatory framework patient-focused as artificial intelligence and persona…
    raps · 6d agoRegulatoryNeutral↗ source
  • Immune Boost Capital backs Orthrus Therapeutics to advance antigen-specific immune tolerance for rheumatoid arthritis
    Immune Boost Capital, the venture arm of the Arthritis National Research Foundation, announced an investment in Orthrus Therapeutics, a biotech focused on precision therapies for autoimmune disease…
    Fierce Biotech · 6d agoDealPositive↗ source
  • BD and CareFusion recall Alaris Pump infusion sets due to serious performance risks
    The FDA has classified the recall of BD Alaris Pump infusion sets as the most serious type, warning that continued use could cause serious injury or death. BD and its subsidiary CareFusion sent an…
    fda medwatch · 6d agoCRLNegative↗ source
  • Biomea posts modest Phase 1 results for oral GLP-1 drug, shares slide
    Biomea Fusion released Phase 1 data for its oral small‑molecule GLP‑1 agonist BMF‑650, positioning the program as a potential partner opportunity that could separate efficacy from gastrointestinal…
    Fierce Biotech · 6d agoNegative readoutNegative↗ source
  • Verdiva Bio halts phase 2 oral GLP-1 trial after enrolling only eight participants
    Verdiva Bio announced it is ending its phase 2 study of VRB-101, a once‑weekly oral GLP‑1 candidate, after the trial fell far short of its enrollment target. The study was intended to evaluate swi…
    Fierce Biotech · 6d agoNegative readoutNegative↗ source
  • Convenience Kit Recall: AVID Medical Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall
    Avid Medical is removing certain convenience kits affected by the BD ChloraPrep Applicator Recall that may be contaminated with Aspergillus penicillioides.
    fda medwatch · 6d ago↗ source
  • Gilead signs $1.9 billion deal with Vir Biotechnology to license dual-masked T-cell engagers for oncology
    Gilead Sciences announced a licensing agreement with Vir Biotechnology to access Vir's dual-masked PRO-XTEN T-cell engager platform for oncology. Under the deal, Vir will discover, design and opti…
    Fierce Biotech · 7d agoDealPositive↗ source
  • Roche signs $1 billion deal with China’s Rona Therapeutics for RNAi obesity drug
    Roche announced a new agreement with Chinese biotech Rona Therapeutics to acquire an experimental RNA interference therapy targeting the protein ALK7 for obesity. Under the terms, Roche will pay $…
    BioPharma Dive · 7d agoDealPositive↗ source
  • iOnctura’s roginolisib shows encouraging phase 1 results in metastatic uveal melanoma
    iOnctura, a spinout of Merck KGaA, reported data from a two‑part phase 1 trial of its PI3K delta inhibitor roginolisib in patients with advanced solid and hematologic cancers, including a cohort of…
    Fierce Biotech · 7d agoPositive readoutPositive↗ source
  • Stryker invests $400 million in CMR Surgical, securing exclusive U.S. rights to Versius robotic platform
    Stryker announced a strategic investment of about $400 million in UK‑based CMR Surgical, a developer of modular, portable surgical robots. Under the agreement, Stryker will act as the exclusive U.…
    Fierce Biotech · 7d agoDealPositive↗ source
  • IQVIA and Veeva deepen partnership to accelerate clinical trial timelines
    IQVIA and Veeva Systems announced an expansion of their existing collaboration aimed at speeding up clinical trial execution and improving efficiency. The upgrade brings Veeva's trial management t…
    Fierce Biotech · 7d agoDealPositive↗ source
  • BioNTech’s mRNA cancer vaccine misses key endpoint in head-and-neck trial, study to continue
    BioNTech reported that its mRNA cancer immunotherapy BNT113 did not improve progression‑free survival when added to Keytruda in patients with HPV16‑positive head and neck squamous cell carcinoma. T…
    Fierce Biotech · 7d agoNegative readoutNegative↗ source
  • Roche licenses Rona's ALK7 obesity candidate in $1.2 billion deal
    Roche has agreed to license an RNAi drug candidate targeting ALK7 from Chinese biotech Rona Therapeutics, with an upfront payment of $100 million and potential milestones up to $1.06 billion. The…
    Fierce Biotech · 7d agoDealPositive↗ source
  • Study urges regulators to adopt cloud platforms to speed drug approvals
    A new study led by Nina Cauchon of Amgen and co-authors, published in the Journal of Pharmaceutical Sciences, calls for broader use of cloud-based platforms by regulatory agencies. The authors arg…
    raps · 7d agoRegulatoryPositive↗ source
  • Connectivity in fluid management systems key to reducing process variability
    The sponsored article, authored by Chris McCoy of Cytiva, highlights the often‑overlooked role of fluid‑management components such as tubing, connectors, and sensors in bioprocesses. It argues tha…
    BioPharma Dive · 7d agoPositive↗ source
  • Saudi Arabia signs 46 biotech agreements at Riyadh summit, targeting $1.5 bn investment
    The fourth Riyadh Global Medical Biotechnology Summit wrapped up on September 16, with 46 agreements signed among local and international participants. The disclosed agreements represent about 5.5…
    Fierce Biotech · 7d agoDealPositive↗ source
  • WCG launches AI-driven Activation Intelligence to speed clinical trial start-ups
    WCG, a provider of clinical trial solutions, announced a new AI-powered program called Activation Intelligence aimed at accelerating the start-up phase of studies. In early access, the tool report…
    Fierce Biotech · 7d agoPositive↗ source
  • Medline pulls convenience kits containing recalled BD ChloraPrep applicators due to contamination risk
    Medline has advised that certain convenience kits it distributes must be removed from use and destroyed because they contain BD ChloraPrep applicators that are subject to a recall over possible fun…
    fda medwatch · 7d agoCRLNegative↗ source
  • Insulet launches full U.S. release of Omnipod Discover data platform for Omnipod 5 users
    Insulet announced that its Omnipod Discover platform is now fully available across the United States. The web-based service is built to work with the company’s Omnipod 5 automated insulin delivery…
    Fierce Biotech · 7d agoPositive↗ source
  • Stakeholders urge FDA to adopt flexible approach for psychedelic drug regulation
    Various individuals and groups have submitted comments urging the U.S. Food and Drug Administration to be flexible in regulating psychedelic medicines that could treat major depressive disorder and…
    raps · 7d agoRegulatoryNeutral↗ source
  • Roche signs $1.2B partnership with China’s Rona for obesity drug as Stryker pours $400M into CMR Surgical
    Roche has entered a $1.2 billion agreement with Chinese firm Rona to advance an obesity treatment, targeting the growing market for weight‑loss therapies in China. The deal will combine Roche’s dr…
    raps · 7d agoDealPositive↗ source
  • Paragon spinout Velaris Therapeutics goes public via reverse merger with Alaunos, raising $350 million
    Paragon Labs, a biotechnology incubator, announced that its latest spinout, Velaris Therapeutics, became a public company through a reverse merger with Alaunos Therapeutics. The transaction places…
    BioPharma Dive · 7d agoDealPositive↗ source
  • BioNTech's mRNA cancer therapy fails to improve progression-free survival in head-neck cancer trial
    BioNTech reported that its experimental mRNA cancer immunotherapy, BNT 113, combined with Keytruda, did not meet the primary endpoint of progression-free survival in an interim analysis of a late-s…
    BioPharma Dive · 7d agoNegative readoutNegative↗ source