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3,113 stories matching this filter · ← front page

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  • Inhibrx reports 44% response rate when paired with Keytruda in head-and-neck cancer Phase 2 trial
    Inhibrx Biosciences said its experimental agent INBRX-106 boosted the activity of Merck's Keytruda in a Phase 2 study of a head-and-neck cancer. The combination achieved a 44% overall response rate…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • Astellas revisits gene therapy for XLMTM, offering new hope after earlier setbacks
    A gene therapy for the rare muscle disorder X‑linked myotubular myopathy (XLMTM) showed mixed results in early trials, with some boys experiencing dramatic recoveries while others died. Astellas P…
    STAT · 4mo agoPositive↗ source
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  • Supreme Court pauses restrictions, keeps abortion pill mifepristone available through pharmacies and mail
    The Supreme Court issued an order that maintains current access to the abortion medication mifepristone while it reviews a case challenging FDA prescribing rules. The order, signed by Justice Samu…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Colombian court upholds compulsory license for HIV drug, affirming legal framework
    The Court of Justice of the Andean Community ruled that Colombia's issuance of a compulsory license for an HIV medicine two years ago was lawful. The tribunal said the government had a valid publi…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Medicare falls short on projected Alzheimer’s drug costs as fewer seniors use Leqembi
    Bob Herman reports that Medicare's earlier estimate that the new Alzheimer's therapy Leqembi would cost the program $3.5 billion in 2025 has proved far too high. The agency's actuaries based the fo…
    STAT · 4mo agoRegulatoryNegative↗ source
  • FDA policy lets some flavored vapes stay on shelves without full approval, raising expert concerns
    The Food and Drug Administration announced a new guidance that allows certain flavored e-cigarettes and nicotine pouches to remain on the market even though they have not received full authorizatio…
    STAT · 4mo agoRegulatoryNegative↗ source
  • GSK partners with Sino Biopharma to expand access to hepatitis B drug bepirovirsen in China
    GSK announced a marketing agreement with Sino Biopharmaceutical to distribute its experimental hepatitis B therapy bepirovirsen in China. Sino's subsidiary will purchase a supply of the drug and u…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Daiichi Sankyo targets $15 billion in oncology sales by 2030 as it expands ADC franchise
    Daiichi Sankyo released a new five‑year business plan that sets a goal of nearly $15 billion in oncology revenue by 2030. The target is part of a broader ambition to push total company sales past 3…
    Endpoints · 4mo agoNeutral↗ source
  • Inhibrx reports combo of Keytruda and INBRX-106 reduces tumors more than Keytruda alone in metastatic head cancer
    San Diego biotech Inhibrx says its experimental drug INBRX-106, when added to Merck's immunotherapy Keytruda, led to a higher rate of tumor shrinkage than Keytruda by itself. The observation comes…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Astellas therapy brings new hope to rare disease patients amid broader biotech challenges
    A new Astellas treatment is being highlighted as a source of optimism for a community affected by a rare disease, after a period of setbacks in the program. The article also notes a revived gene t…
    STAT · 4mo agoPositive↗ source
  • Braveheart Bio's Hengrui-licensed cardiac therapy shows positive mid-stage trial results
    Braveheart Bio announced that its heart muscle therapy, licensed from Jiangsu Hengrui Pharmaceuticals, has achieved a positive outcome in a Phase 2 trial. The mid-stage study met its primary endpo…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Biotech layoffs slow as companies like BioNTech cut nearly 1,900 jobs amid market pressures
    The biotech sector has seen more than 40 layoff announcements through the end of April 2026, a decline from the over 50 rounds reported in the final months of 2025. Analysts had expected the pace t…
    BioPharma Dive · 4mo agoLayoffsNegative↗ source
  • Medicare uptake of newly approved Alzheimer’s drugs Leqembi and Kisunla falls short of expectations
    Medicare is seeing much lower use of the two Alzheimer’s treatments that received FDA approval earlier this year. The drugs, Leqembi and Kisunla, were expected to generate notable spending for Med…
    STAT · 4mo agoRegulatoryNegative↗ source
  • European regulators approve Fractyl Health's first GLP-1 gene therapy clinical trial
    European regulators have given the green light for Fractyl Health, a biotech near Boston, to begin its first human study of a GLP-1 gene therapy. The therapy aims to provide a one-time treatment t…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • Specialized logistics critical for delivering next-generation cell and gene therapies
    The article explains that personalized medicines such as cell and gene therapies are transforming treatment for rare diseases and cancers. Unlike conventional drugs, these therapies are often made…
    BioPharma Dive · 4mo agoNeutral↗ source
  • Biopharma capacity crunch shifts focus to ready-now manufacturing hubs like Middlesex County, NJ
    Demand for biopharma manufacturing, especially cell and gene therapies, is growing faster than the ability to build new GMP-ready facilities, which can take years to complete. To keep pace, compan…
    BioPharma Dive · 4mo agoNeutral↗ source
  • Experts call for licensing framework as Utah pauses AI chatbot prescription program
    Alon Bergman, an assistant professor of medical ethics at the University of Pennsylvania, argues that AI-driven medical tools need a licensing system. He points to Utah’s recent pilot with the AI c…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Medicare cuts projected spending on new Alzheimer’s drugs as uptake remains low
    Medicare is spending far less on the recently approved Alzheimer’s treatments Leqembi and Kisunla than officials had anticipated. The Centers for Medicare and Medicaid Services said the agency does…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Optum Rx Announces Transparent Pharmacy Model Set to Launch in 2027
    Optum Rx, a unit of UnitedHealth Group, introduced a new pharmacy benefit model that promises clear fee structures for its customers. The model is designed to give members visibility into the full…
    Endpoints · 4mo agoPositive↗ source
  • Novo Nordisk secures biotech partner for Parkinson's cell therapy as GSK signs hepatitis B drug deal in China
    Novo Nordisk has found a biotech partner to advance its early‑stage Parkinson's disease cell therapy, giving the program a new development home. GSK disclosed a commercial agreement to sell its he…
    Endpoints · 4mo agoDealNeutral↗ source
  • Providers and insurers vie to influence upcoming No Surprises Act arbitration rule
    The federal government is preparing to release a final rule that will reshape the arbitration process under the No Surprises Act. Health care providers and insurers are both scrambling to have thei…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • President Trump says government may consider approving certain forms of kratom-derived 7-OH
    President Trump suggested the federal government could move to approve some forms of 7-OH, an opioid derived from the kratom plant. 7-OH, short for 7-hydroxymitragynine, occurs naturally in kratom…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • FDA commissioner Marty Makary faces possible dismissal amid political pressure, while new insights link menstrual cycles to mental health
    Theresa Gaffney’s Morning Rounds newsletter highlighted a growing body of research that connects menstrual cycle patterns with fluctuations in mental health, underscoring the importance of gender‑s…
    STAT · 4mo agoNeutral↗ source
  • AI dependence mirrors addiction, warns psychiatrist, sparking debate on hidden costs
    Jonathan Avery, vice chair for addiction psychiatry at Weill Cornell Medicine, reflects on his podcast about addiction and the mixed feedback he receives. In a recent episode he interviewed NYU ne…
    STAT · 4mo agoNeutral↗ source
  • Dermatophilosis identified in clusters of European gay men, a mild livestock skin disease
    Researchers in France and Spain have diagnosed several men who have sex with men with dermatophilosis, a bacterial skin infection normally seen in livestock. The cases occurred without any known c…
    STAT · 4mo agoNeutral↗ source