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  • Yarrow Bioscience raises $150M as AbbVie reports positive menstrual migraine trial results
    Yarrow Bioscience, based in New Haven, announced pricing of a $150 million equity offering at $26 per share, roughly $2.50 below the previous closing price. The capital raise will provide addition…
    Endpoints · 16h agoPositive readoutPositive↗ source
  • Trade group warns stalled biosimilar development could forfeit billions in savings
    A trade association that represents generic drug makers and biosimilar developers released a new report warning that progress on biosimilar products has slowed. The group says the slowdown threaten…
    Endpoints · 16h agoNegative↗ source
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  • RA Capital backs four biotech rounds in September as Novartis shares tumble after trial setbacks
    RA Capital Management participated in four biotech financings in September, including Series A rounds for Solstice Oncology and Tectora Therapeutics, as well as co-leading a $56 million round for T…
    BioPharma Dive · 16h agoDealNeutral↗ source
  • Karyopharm Secures One-Month Debt Extension While Awaiting Xpovio Decision
    Karyopharm Therapeutics, facing cash constraints, has negotiated a temporary reprieve on a $15.8 million debt that was due. Under the agreement, lenders and noteholders will refrain from enforceme…
    BioPharma Dive · 18h agoDealNeutral↗ source
  • Takeda R&D chief Andy Plump to retire in 2027 as Novo Nordisk names Alex Hoffman global research head
    Takeda announced that its head of research and development, Andy Plump, will step down in June 2027. Plump, who joined Takeda from Sanofi in 2015 and has led R&D since December 2018, will retire af…
    Endpoints · 21h agoNeutral↗ source
  • Alzheon seeks up to $500M in new financing after Phase 3 setback for Alzheimer’s drug
    Alzheon, a biotech based in Framingham, Massachusetts, has been pursuing an Alzheimer’s therapy for more than a decade. Its lead candidate recently failed to achieve the primary goals in a Phase 3…
    Endpoints · 17h agoDealNeutral↗ source
  • mRNA cancer vaccines’ biggest barriers to market
    Manufacturing hurdles are just one challenge the industry must overcome to commercialize personalized mRNA cancer vaccines.
    BioPharma Dive · 20h agoRegulatoryNeutral↗ source
  • FDA plans study on barriers to women's enrollment in pregnancy exposure registries and announces PRV fee rates
    The Food and Drug Administration said it will conduct research into perceived barriers that limit women’s participation in pregnancy exposure registries. It also released the fee schedule for prio…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA grants three-month review extension for Exelixis' metastatic colorectal cancer candidate
    Exelixis, a California drug developer, has provided the FDA with additional safety and efficacy data for its experimental therapy aimed at treating metastatic colorectal cancer. The agency respond…
    Endpoints · 16h agoRegulatoryNeutral↗ source
  • FDA signals openness to innovative trial designs for psychedelic therapies
    FDA regulators said they are willing to consider more flexible approaches for evaluating psychedelic medicines. The agency noted that studies could use active comparators instead of placebo, which…
    Endpoints · 1d agoRegulatoryPositive↗ source
  • FDA issues partial hold on Biohaven’s experimental epilepsy drug opakalim, pausing recruitment in late-stage trial
    Biohaven announced that the FDA has placed a partial hold on its experimental epilepsy therapy, opakalim, after the company recently transferred rights to the drug in a licensing agreement. The ag…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
  • Shionogi's mid-stage stroke drug redasemtide fails, while Bayer's Hyrnuo receives expanded NSCLC label
    Shionogi reported that its experimental stroke therapy redasemtide did not achieve the primary endpoint in a mid-stage clinical trial, marking a setback for the company’s neurology pipeline. The f…
    Endpoints · 1d agoNegative readoutNeutral↗ source
  • ARPA-H launches ADVOCATE program to fund AI agents for health tech companies
    ARPA-H, the federal agency that funds breakthrough health technologies, announced the start of a new initiative called ADVOCATE. The program will award millions of dollars in grants to health-tech…
    Endpoints · 1d agoPositive↗ source
  • FDA imposes partial clinical hold on Biohaven's experimental epilepsy drug BHV-7000
    FDA announced a partial clinical hold on Biohaven's ion channel program, affecting the epilepsy trial of the experimental drug BHV-7000. The hold was issued after the agency requested additional p…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • Reverse mergers surge as biotech firms seek public listings via shell companies
    Reverse mergers, once dismissed, are now a common route for biotech startups to gain a public listing by merging with shell companies. Data from JB Strategy Partners shows roughly two dozen such d…
    BioPharma Dive · 1d agoDealNegative↗ source
  • BridgeBio Oncology shares tumble 24% as it narrows KRAS program focus
    BridgeBio Oncology Therapeutics saw its stock drop sharply after announcing a strategic shift. The company said it will scale back its broader pipeline to concentrate resources on its lead KRAS in…
    Endpoints · 1d agoNegative↗ source
  • Pharma investment in UK rises as government increases drug pricing and engagement
    The UK trade group says pharmaceutical investment is picking up after a lull last year. The uptick follows recent government steps to raise reimbursement rates for medicines and to foster closer c…
    Endpoints · 2d agoRegulatoryPositive↗ source
  • UK issues AI-in-medicine regulatory recommendations; FDA pauses new enrollment in Biohaven epilepsy trials
    The United Kingdom has released a set of recommendations aimed at governing the use of artificial intelligence in medical applications. The guidance outlines how AI tools should be evaluated and mo…
    raps · 2d agoRegulatoryNeutral↗ source
  • Takeda R&D chief Andy Plump to retire in June 2027, will stay on board through 2027
    Takeda announced that Andy Plump, who has led the company's research and development since 2015, will retire in June 2027. Plump will remain president of R&D until a successor is appointed and wil…
    BioPharma Dive · 1d agoNeutral↗ source
  • Lonza announces new spray-drying plant in Bend, Oregon as Samsung Bio secures $262 million contract
    Lonza announced plans to construct a new commercial spray-drying facility in Bend, Oregon, expanding its manufacturing footprint in the United States. The plant will increase Lonza’s capacity to p…
    Endpoints · 1d agoPositive↗ source
  • FDA signals openness to innovative approaches for psychedelic drug development
    FDA officials said the agency is open to novel, innovative approaches to the clinical development of psychedelic drugs, citing the worsening mental health crisis in the United States. The agency’s…
    raps · 2d agoRegulatoryNeutral↗ source
  • Biotech industry rebounds as Endpoints 11 awards return in Boston
    The article notes that the Endpoints 11 awards will be unveiled in Boston on the night of September 24, marking the event’s return after a period of industry slowdown. It reflects on how the biote…
    Endpoints · 1d agoNeutral↗ source
  • EMA revises GVP inspection guideline to incorporate new subcontractor rules
    The European Medicines Agency has issued an update to its guideline on good pharmacovigilance practice inspections. The revision aligns the guidance with recent changes to the rules governing subco…
    raps · 2d agoRegulatoryNeutral↗ source
  • Oura files S-1, outlining its plans to expand into healthcare as it prepares for IPO
    Oura, known for its sleep-tracking ring, has submitted a registration statement on Form S-1 as it moves toward an initial public offering. In the filing, the company describes a broader healthcare…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • Medical Action Industries issues correction for epidural kits containing recalled Huons Co. lidocaine ampules
    Medical Action Industries has released a correction notice for several of its epidural kit products after discovering that they contain lidocaine ampules from Huons Co. that were previously recalle…
    fda medwatch · 2d agoCRLNeutral↗ source