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1,881 stories matching this filter · ← front page

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  • Disc sets up polycythemia vera challenge but Silence maintains lead
    The polycythemia vera field is heating up, with Disc Medicine and Silence Therapeutics each advancing next-generation therapies, playing catch-up to Takeda and Protagonist Therapeutics, who won the…
    BioSpace · 6h agoApprovalPositive↗ source
  • Novartis shares tumble as three late-stage drug candidates fail trials
    Novartis' stock fell more than 13% this week after news that three of its late-stage programs did not meet expectations, pulling down other pharma stocks in the market. The antibody‑oligonucleotid…
    BioSpace · 8h agoNegative↗ source
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  • Novartis shares tumble 13% after three late-stage drug setbacks hit market
    Novartis' stock dropped more than 13% this week after three of its late-stage programs reported setbacks, pulling down other pharma stocks. The antibody-oligonucleotide conjugate del-desiran faile…
    BioSpace · 8h agoNegative readoutNegative↗ source
  • Novartis board under fire as two late-stage trials fail and CAR-T program paused
    Novartis' board is facing heightened investor scrutiny after the Swiss drugmaker reported failures in two pivotal late-phase trials, raising doubts about its capital deployment strategy for growth…
    BioSpace · 14h agoNegative readoutNegative↗ source
  • Samsung Biologics secures $262 million manufacturing contract with European pharma firm
    Samsung Biologics announced a $262 million agreement to provide manufacturing services to an unnamed European pharmaceutical company. The contract runs through 2033. The deal will be executed at S…
    BioSpace · 5h agoDealPositive↗ source
  • Frazier Life Sciences raises over $1.1 billion for its small-mid-cap biotech fund, total commitments now $2.8 billion
    Frazier Life Sciences announced that it has added more than $1.1 billion in new capital to its public fund that targets small and mid‑size biopharma companies. The infusion brings the fund's total…
    BioSpace · 6h agoDealPositive↗ source
  • 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 · 3h 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 · 3h agoNegative↗ source
  • 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 · 3h 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 · 5h 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 · 7h agoNeutral↗ source
  • FDA leadership stabilizes under new CBER and CDER heads and appoints first AI deputy commissioner
    At the Food and Drug Administration, Karim Mikhail and Michael Davis have been confirmed as the permanent heads of the Center for Biologics Evaluation and Research and the Center for Drug Evaluatio…
    BioSpace · 14h agoRegulatoryPositive↗ 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 · 3h 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 · 6h 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 · 2h agoRegulatoryNeutral↗ source
  • BioSpace to Host Webinar on Using Podcasts, Webinars and Thought Leadership for Pharma Marketing
    BioSpace announced a webinar that will walk PR, communications and marketing teams through the use of podcasts, webinars and thought‑leadership programs to raise executive visibility in biotech and…
    BioSpace · 5h agoNeutral↗ source
  • Encoded Therapeutics secures $275M Series F to advance gene therapy for Dravet syndrome
    Encoded Therapeutics announced a $275 million Series F financing round aimed at moving its lead gene‑therapy candidate, ETX101, toward pivotal trials for Dravet syndrome. In the ongoing Phase 1/2…
    BioSpace · 1d agoDealPositive↗ 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 pauses enrollment in Biohaven's epilepsy trials after earlier depression trial failure
    FDA placed a partial clinical hold on Biohaven's Kv7 potassium channel agonist, BHV-7000 (opakalim), halting enrollment of new patients in two late-stage focal epilepsy studies. The pause follows…
    BioSpace · 1d agoRegulatoryNegative↗ 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
  • Drugmakers Rethink Launch Strategies as MFN Pricing Rules Shake Market
    A new Numerof & Associates report says that the rollout of Most Favored Nation (MFN) pricing rules is forcing drugmakers to overhaul how they choose launch markets. Executives surveyed said the Un…
    BioSpace · 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