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  • AstraZeneca halts Phase 3 lung cancer trial of bispecific antibody volrustomig after interim data miss survival goal
    AstraZeneca announced termination of the Phase 3 study of its experimental bispecific antibody volrustomig in non‑small cell lung cancer. An interim data review by trial monitors indicated the dru…
    BioPharma Dive · 2d agoNegative readoutNegative↗ source
  • AstraZeneca reports positive late-stage results for Tagrisso-Orpathys combo and Enhertu in lung cancer
    AstraZeneca said on Monday that two separate late-stage studies in lung cancer have produced positive outcomes. One study evaluated a combination of the tyrosine-kinase inhibitor Tagrisso with the…
    Endpoints · 2d agoPositive readoutPositive
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  • Eli Lilly signs up to $370 million ion-channel collaboration with OmniAb
    Eli Lilly announced a collaboration and licensing agreement with California-based drug discovery company OmniAb that will focus on ion-channel targets. The deal could see Lilly paying up to $370 m…
    Endpoints · 2d agoDealNeutral↗ source
  • Drugmakers Back US Probe into Germany’s New Drug Pricing Policies
    Seven major pharmaceutical companies, together with industry groups PhRMA and BIO, have urged the German government to amend its recently introduced drug‑pricing reforms. The coalition voiced supp…
    Endpoints · 2d agoRegulatoryNegative↗ source
  • EyePoint’s Phase 3 eye drug falls short of Eylea, stock tumbles 70%
    EyePoint reported that its experimental treatment for wet age-related macular degeneration did not meet the efficacy endpoints in a Phase 3 trial when compared with the current standard, Eylea. The…
    Endpoints · 2d agoNegative readoutNegative↗ source
  • Biotech raises $820M to bring China-sourced immunology drug to market via reverse merger
    A biotech company has secured $820 million in investor commitments this month to bring its immunology drug, developed in China, to public markets. The funding will be used to complete a reverse me…
    Endpoints · 2d agoDealPositive↗ source
  • Summit and Akeso's ivonescimab wins Chinese first-line lung cancer approval, but longer follow-up shows reduced benefit
    Summit Therapeutics and Akeso announced that their next‑generation PD‑1xVEGF bispecific antibody, ivonescimab, received regulatory approval in China for first‑line treatment of certain lung cancer…
    Endpoints · 2d agoApprovalNegative↗ source
  • EyePoint’s Phase 3 trial of duravyu fails to outperform aflibercept, shares plunge 70%
    EyePoint announced that its Phase 3 Lugano trial of the investigational tyrosine kinase inhibitor duravyu did not meet the primary efficacy endpoint when compared with the standard‑of‑care anti‑VEG…
    BioSpace · 2d agoNegative readoutNegative↗ source
  • Summit Therapeutics and Akeso celebrate third China approval for ivonescimab as new data show waning survival benefit
    Summit Therapeutics and its partner Akeso received a third approval in China for ivonescimab, a PD-1/VEGF bispecific antibody, for first-line treatment of advanced squamous non-small cell lung canc…
    BioSpace · 2d agoRegulatoryNegative↗ source
  • AstraZeneca halts late-stage lung cancer trial of volrustomig after disappointing interim results
    AstraZeneca announced it is stopping a Phase 3 study of its bispecific antibody volrustomig in metastatic non-small cell lung cancer after an interim analysis showed the drug is unlikely to meet it…
    BioSpace · 2d agoNegative readoutNegative↗ source
  • AstraZeneca halts late-stage lung cancer trial of volrustomig after disappointing interim results
    AstraZeneca said it is ending its Phase 3 eVOLVE-Lung02 trial that evaluated the bispecific antibody volrustomig combined with chemotherapy as a first-line option for metastatic non-small cell lung…
    BioSpace · 2d agoNegative readoutNegative↗ source
  • Vera Therapeutics receives FDA accelerated approval for Trutakna, an IgA nephropathy drug showing promising kidney function stabilization
    Vera Therapeutics announced that its IgA nephropathy therapy Trutakna has been granted accelerated approval by the U.S. Food and Drug Administration. The approval follows the agency's review of dat…
    BioSpace · 2d agoApprovalPositive↗ source
  • Argenx reports Phase 3 success for Vyvgart Hytrulo in autoimmune myositis, despite subgroup shortfall
    Argenx announced that its subcutaneous antibody Vyvgart Hytrulo achieved its primary endpoint in a Phase 3 trial for autoimmune myositis, a rare group of inflammatory muscle diseases. The trial de…
    Endpoints · 2d agoPositive readoutPositive↗ source
  • AstraZeneca halts Phase 3 lung cancer trial of volrustomig after negative results
    AstraZeneca announced on Monday that it is ending the Phase 3 study of its lung-cancer drug volrustomig after the trial failed to meet its primary efficacy endpoints. The company said the data did…
    Endpoints · 2d agoNegative readoutNegative↗ source
  • Italian biotech sector gains traction as venture capital and tech transfer improvements boost startups
    Italy has long been recognized for its high‑quality scientific research, yet converting that output into successful biotech startups has been a persistent challenge. Recent years have seen a shift…
    BioSpace · 3d agoPositive↗ source
  • Experts say AI could outperform doctors on basic tasks by 2030
    Most clinical AI tools being built today are intended to work under a doctor's supervision. Healthcare and venture-capital experts predict that by 2030 AI may independently perform better than phy…
    Endpoints · 2d agoNeutral↗ source
  • J&J returns rights to lymphoma CAR‑T therapy prizlon‑cel to AbelZeta
    Johnson & Johnson secured exclusive rights to the bispecific CAR T candidate prizlon‑cel in 2023, paying an upfront $245 million. The therapy, designed for large B‑cell lymphoma, achieved a 100% r…
    BioSpace · 2d agoDealNeutral↗ source
  • Celcuity waits on FDA review of second plant as cancer drug rollout lags expectations
    Celcuity has announced that it is awaiting the U.S. Food and Drug Administration’s review of a second manufacturing facility needed for its newly approved cancer therapy. The company explained tha…
    Endpoints · 2d agoRegulatoryNeutral↗ source
  • How AI-enabled Software as Medical Devices are Reshaping Regulatory Routes and Medicine
    As AI-enabled Software as Medical Devices become more prevalent, regulatory agencies are responding with new guidelines and AI-specific authorisation routes. This article looks at current trends, s…
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Slate Medicines to merge with Fulcrum Therapeutics after Fulcrum drops sickle-cell drug
    Slate Medicines announced it will combine with Fulcrum Therapeutics in a reverse merger, giving the struggling biotech a new corporate home. Fulcrum had been developing pociredir, a therapy design…
    BioPharma Dive · 2d agoDealNegative↗ source
  • Trump orders MMR vaccine as LSD-targeted drug passes Phase 3 trial
    The latest Endpoints Weekly notes that President Trump placed an order for the measles‑mumps‑rubella (MMR) vaccine. The newsletter also reports that a drug being developed for LSD‑related indicati…
    Endpoints · 4d agoPositive readoutNeutral↗ source
  • EU regulator withdraws Amgen's Tavneos authorization over serious trial breaches
    European regulators have withdrawn the marketing authorization for Amgen's rare disease drug Tavneos, citing serious breaches in the pivotal clinical trial. The EMA said study staff from ChemoCent…
    BioSpace · 5d agoRegulatoryNegative↗ source
  • Biotech firm Biogen secures Chinese approval for felzartamab in second-line multiple myeloma
    Biogen announced that its monoclonal antibody felzartamab has received regulatory clearance in China for use in patients with multiple myeloma who have already received first-line therapy. The app…
    Endpoints · 5d agoApprovalPositive↗ source
  • Capricor shares jump as FDA signals openness to review updated Duchenne therapy
    Capricor Therapeutics saw its stock rise sharply after CEO Linda Marbán told analysts that the FDA is willing to look at an amended filing for its Duchenne muscular dystrophy cell therapy, deramioc…
    BioPharma Dive · 5d agoRegulatoryPositive↗ source
  • FDA grants accelerated approval to BMS’s iberdomide, branded Zenbexus, as generic competition hits Revlimid and Pomalyst sales
    The FDA has granted accelerated approval to iberdomide, now marketed as Zenbexus, for patients with multiple myeloma who have received at least one prior line of therapy. The drug is to be used in…
    BioSpace · 5d agoApprovalNeutral↗ source