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1,465 stories matching this filter · ← front page

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  • 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 · 2h agoPositive readoutPositive↗ 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 · 21m agoRegulatoryNegative↗ source
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Infectious Disease334
  • 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 · 2h 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 · 2h 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 · 3h agoApprovalNegative↗ 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 · 3h agoRegulatoryNegative↗ 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 · 5h 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 · 5h 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 · 6h 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 · 7h agoNegative readoutNegative↗ source
  • Eli Lilly signs up to $370M ion-channel collaboration with OmniAb
    Eli Lilly has entered a collaboration with antibody platform company OmniAb that could involve up to $370 million in research, development and commercial milestone payments. OmniAb, which was spun…
    Fierce Biotech · 10h agoDealPositive↗ 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 · 10h agoPositive↗ source
  • AstraZeneca halts phase 3 lung cancer trial of bispecific antibody volrustomig after it falls short of Keytruda
    AstraZeneca stopped its phase 3 trial of the bispecific antibody volrustomig in metastatic non‑small cell lung cancer after interim data suggested the regimen would not meet the study's primary goa…
    Fierce Biotech · 13h agoNegative readoutNegative↗ 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 · 6h agoDealNeutral↗ source
  • FDA clears Lantheus' Tauklarify PET imaging agent for Alzheimer’s tau detection
    Lantheus received FDA clearance for its PET imaging agent Tauklarify, also known as MK-6240, which is designed to help diagnose Alzheimer’s disease by visualizing tau protein deposits. The clearan…
    Fierce Biotech · 9h agoRegulatoryPositive↗ 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 · 12h agoRegulatoryNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 3h agoLayoffsNegative↗ source
  • EyePoint’s Phase 3 fail sends stock spiraling amid next-gen AMD race
    EyePoint’s quest to reduce treatment burden for patients with age-related macular degeneration has hit a bump in the road, with a clinical miss driving the biotech’s stock down by 70%.
    BioSpace · 3h ago↗ source
  • Lilly to pay up to $370M for OmniAb collab; Slate, Fulcrum forge reverse merger
    🤝 OmniAb’s Lilly pact: The California drug discovery shop has an ion channel collaboration and licensing agreement in place with the GLP-1 giant. Eli Lilly will pay up to $370 million ...
    Endpoints · 3h ago↗ source
  • Celcuity awaits FDA review for second factory to launch cancer drug
    Celcuity has provided further details on why the commercial rollout of its recently approved cancer drug is slower than investors initially anticipated. The drugmaker said it is waiting for the FDA…
    Endpoints · 4h ago↗ source
  • Merck KGaA lays off 20 staffers in latest blow to US research team
    The Massachusetts research site for Merck KGaA’s North American division, EMD Serono, has decided to hand pink slips to 20 staffers, Fierce has learned.
    Fierce Biotech · 4h ago↗ source
  • Slate uses Fulcrum to vault onto Nasdaq with $245M financing for migraine trials
    Slate Medicines is hurtling toward a Nasdaq listing, securing a reverse merger with Fulcrum Therapeutics six months after exiting stealth and ahead of the publication of clinical data on its lead c…
    Fierce Biotech · 8h ago↗ source
  • Evaxion scraps solid tumor vaccine to focus on Duke-partnered brain cancer candidate
    Evaxion has scrapped a next-gen solid tumor vaccine in order to channel resources to a candidate specifically targeting brain cancer.
    Fierce Biotech · 8h ago↗ source
  • Baylor Genetics hit by cybersecurity attack targeting patient, staff information
    Diagnostic genomics company Baylor Genetics has become the latest victim of a life sciences cybersecurity breach, with both patients and employees affected.
    Fierce Biotech · 11h ago↗ source
  • Experts propose safety framework for improving predictability, interpretation of CNS toxicity
    The use and implementation of new approach methodologies (NAMs) and digital technologies such as artificial intelligence (AI) may help improve the predictability and interpretation of central nervo…
    raps · 17h ago↗ source