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3,336 stories matching this filter · ← front page

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  • U.S. Health Care System's Economics Are Broken, Says Ascendiun CEO
    Paul Markovich, president and CEO of Ascendiun, argues that the economics of the United States health care system are fundamentally broken. He recounts meeting a healthy, active man in his early 6…
    STAT · 11d agoNegative↗ source
  • FDA issues draft guidance to streamline approval of personalized gene therapies
    The FDA released a draft guidance that outlines an "adapted pathway" for regulating gene‑edited medicines. The new framework is intended to speed the development and approval of personalized gene t…
    BioSpace · 11d agoRegulatoryPositive↗ source
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  • Karyopharm files for Chapter 11 bankruptcy as it pursues merger with Ayrmid
    Karyopharm Therapeutics has filed for Chapter 11 bankruptcy while seeking a merger with U.K. biotech Ayrmid. The court‑supervised process is intended to provide a financial lifeline for the company…
    BioSpace · 10d agoNegative↗ source
  • Washington resident dies after bird flu infection linked to dairy cattle exposure
    A resident of Yakima County, Washington, died from complications of avian influenza after being exposed to infected cattle at a dairy farm. Health officials said the infection was the H5N1 strain,…
    STAT · 10d agoNegative↗ source
  • Sun Pharma halts eye-care drug production in India after regulator cited quality failures
    Sun Pharma has stopped manufacturing eye-care medicines at its Assam facility after Indian regulators identified failures in the company's quality management system. The company previously recalle…
    BioSpace · 10d agoRegulatoryNegative↗ source
  • Tiziana's lower-dose foralumab cuts neuroinflammation in SPMS, but higher dose fails
    Tiziana Life Sciences reported that its intranasal anti‑CD3 antibody, foralumab, lowered a neuroinflammation biomarker in patients with non‑active secondary progressive multiple sclerosis when give…
    BioSpace · 11d agoNegative readoutNegative↗ source
  • FDA accepts first Keytruda biosimilar application as Merck faces looming patent cliff
    The U.S. Food and Drug Administration has accepted the first publicly announced filing for a Keytruda biosimilar, identified as FYB206, which could receive approval as early as the third quarter of…
    BioPharma Dive · 11d agoRegulatoryNeutral↗ source
  • Woman travels to Albania for experimental mitochondrial replacement therapy amid global fertility industry concerns
    A STAT reporter detailed a case of a woman named Heidy Willis who, after multiple failed IVF cycles, sought an experimental fertility option abroad. Willis traveled to Albania to undergo mitochond…
    STAT · 11d agoNegative↗ source
  • FDA accepts review of Biohaven’s ataxia drug, boosting shares as ArriVent’s lung cancer trial miss drags its stock down
    Biohaven saw its shares jump after the FDA agreed to review its rare‑disease drug for spinocerebellar ataxia. The regulator’s decision lifted the stock by roughly 25% in late October, offering the…
    BioSpace · 11d agoRegulatoryNeutral↗ source
  • Pharma leaders turn to integrated scenario modeling as US MFN pricing reshapes global launch strategies
    The article explains that integrated scenario modeling is becoming a key tool for pharmaceutical executives facing pricing uncertainty and the complexities of worldwide product launches. It refere…
    BioPharma Dive · 11d agoNeutral↗ source
  • Women travel abroad for unproven three-parent IVF marketed to older patients
    STAT investigators found that women are journeying thousands of miles to undergo a mitochondrial‑replacement IVF procedure that is promoted as a fertility option for older patients, even though the…
    STAT · 11d agoNegative↗ source
  • Top pharma firms line up for Summit Therapeutics' ivonescimab after strong China Phase 3 data
    Several major biopharma companies, including AstraZeneca, Pfizer and Revolution Medicines, are expressing strong interest in Summit Therapeutics' Akeso-partnered bispecific antibody ivonescimab. Th…
    BioSpace · 11d agoDealPositive↗ source
  • Saudi Arabia pushes ahead with biotech hub despite regional instability
    Saudi Arabia is constructing a regulatory framework, partnership networks and intellectual property structures to nurture a biotech ecosystem, even as regional political tensions persist. Experts…
    BioSpace · 11d agoPositive↗ source
  • BridgeBio eyes first FDA approval for limb-girdle muscular dystrophy therapy
    BridgeBio Pharma is preparing for a potential launch of its experimental drug BBP-418 aimed at treating limb-girdle muscular dystrophy type 2I/R9, pending FDA decision. The agency has set a review…
    BioSpace · 11d agoRegulatoryPositive↗ source
  • Midterm voters weigh health-care costs as urgent-care visits billed like ERs
    The upcoming midterm elections will see tens of millions of voters consider health‑care affordability, especially those whose coverage comes through their employers. The article points out that ri…
    STAT · 10d agoNegative↗ source
  • U.S. bioscience jobs up 7% from 2021 to 2025: Report
    Bioscience employment rose in 41 states, though not in California, according to a new report from the Biotechnology Innovation Organization and the Council of State Bioscience Associations.
    BioSpace · 11d agoRegulatoryNeutral↗ source
  • Study finds psilocybin does not produce lasting anxiety or depression relief in mice
    Five Bay Area laboratories joined forces to examine whether a single dose of psilocybin could produce lasting reductions in anxiety and depression-like behavior in mice. The study measured behavior…
    STAT · 10d agoNegative readoutNegative↗ source
  • Cancer can be treated safely during pregnancy, says maternal-fetal specialist
    Elyce Cardonick, a maternal-fetal medicine physician and founder of the Cancer and Pregnancy Registry, argues that pregnant cancer patients are often urged to terminate their pregnancies even thoug…
    STAT · 11d agoPositive↗ source
  • STAT calls for input on mitochondrial replacement therapy used in fertility tourism
    STAT is asking patients and clinicians to share their experiences with mitochondrial replacement techniques (MRT), sometimes called three-parent IVF, which are being marketed as a fertility option…
    STAT · 11d agoNeutral↗ source
  • Brad's Raw Chips recalls kale chips over potential thallium contamination
    Snack Right Super Foods, doing business as Brad's Raw Chips, announced a recall of certain Brad's Plant Based Crunchy Kale (2 oz) and Brad's Veggie Chips Kale (3 oz) products because they may conta…
    fda recalls · 10d agoCRLNegative↗ source
  • Midterm election outcomes could reshape U.S. health policy, experts say
    The article notes that regardless of the results, the upcoming midterm elections will have broad effects on the U.S. health system, according to more than two dozen policymakers, lobbyists and expe…
    STAT · 13d agoRegulatoryNeutral↗ source
  • Moderna and Merck’s individualized cancer vaccine shows promising melanoma results but shares tumble after ESMO presentation
    Investors closely watched the European Society for Medical Oncology (ESMO) meeting for updates on an individualized neoantigen cancer vaccine being co‑developed by Moderna and Merck. The therapy, c…
    BioPharma Dive · 13d agoPositive readoutNeutral↗ source
  • Regeneron posts $5.1 billion Q3 revenue, beating forecasts and highlighting strong sales of Dupixent, Eylea HD and Libtayo
    Regeneron reported third‑quarter revenue of $5.1 billion, well above the consensus range of $4.61‑$4.65 billion and representing a 36% increase from the same period last year. The company attribut…
    BioSpace · 14d agoEarningsPositive↗ source
  • Lilly beats forecasts and raises outlook as Novartis steadies and GSK faces investor pressure
    Lilly reported third‑quarter revenue that exceeded analysts' expectations by about 8%, driven by strong demand for its diabetes and obesity treatments Mounjaro and Zepbound. The company also lifted…
    BioPharma Dive · 14d agoEarningsPositive↗ source
  • AbbVie beats Q3 expectations, lifts full-year EPS outlook as immunology and neuroscience drive growth
    AbbVie reported third-quarter results that exceeded analysts' sales and earnings per share forecasts. The company posted $17.4 billion in revenue, driven largely by its immunology franchise which…
    BioSpace · 14d agoEarningsPositive↗ source