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  • FDA seeks new advisory committee members, signaling renewed focus on external expertise
    The FDA announced it is inviting subject‑matter experts and consumer representatives to serve on its advisory committees. The call follows a period when the advisory committees had a reduced role…
    raps · 21d agoRegulatoryNeutral↗ source
  • CMS finalizes GLOBE Medicare drug price demo, projected savings cut to $440 million
    The Centers for Medicare & Medicaid Services (CMS) announced it has completed the GLOBE demonstration program, which is intended to lower the cost of prescription drugs covered by Medicare. Earlie…
    Endpoints · 20d agoRegulatoryNeutral↗ source
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  • AbbVie’s eczema antibody shows statistically significant benefit in Phase 2 trial
    AbbVie presented Phase 2 results for its experimental eczema treatment, an anti‑IL‑13 antibody named Zumilokibart. The study met its primary endpoints, demonstrating statistically significant impr…
    Endpoints · 21d agoPositive readoutNeutral↗ source
  • Beam Therapeutics files lawsuit accusing former scientist of stealing IP to launch Chinese biotech venture
    Beam Therapeutics has initiated legal action alleging that a former employee misappropriated proprietary gene-editing technology. The company claims the scientist used the stolen information to co…
    STAT · 21d agoCRLNegative↗ source
  • American Biotech Innovation Alliance urges Congress to prioritize US leadership in biopharma
    The American Biotech Innovation Alliance, formed in May, appeared on Capitol Hill on September 30, 2026 to address lawmakers. The group argued that maintaining U.S. dominance in biopharma requires…
    Endpoints · 21d agoNeutral↗ source
  • Ned Sharpless joins Hatteras Venture Partners as managing director, Andrew Witty returns as chairman
    Hatteras Venture Partners, a North Carolina venture capital firm focused on life‑science startups, announced that former National Cancer Institute director Norman “Ned” Sharpless has joined the fir…
    Endpoints · 21d agoDealPositive↗ source
  • Industry groups back FDA draft guidance on single‑trial approvals but seek clearer flexibility rules
    Industry associations and other stakeholders have expressed overall support for the FDA's draft guidance that outlines when a single pivotal trial, supplemented by confirmatory evidence, can be suf…
    raps · 21d agoRegulatoryNeutral↗ source
  • Researchers create mouse with human-derived brain cortex, sparking ethical and scientific debate
    A research team led by Stanford professor Sergiu Pașca has reported in Nature the creation of a laboratory mouse whose cerebral cortex is built from human brain cells derived from stem cells. The s…
    STAT · 21d agoNeutral↗ source
  • Experts call for regulation of kratom and potent 7-OH products, debate over specific rules
    Kratom leaf products have been sold in the United States for many years without formal regulatory oversight. Users often turn to them for chronic pain, anxiety, or to ease opioid withdrawal, despit…
    STAT · 21d agoRegulatoryNeutral↗ source
  • Pennsylvania reports four measles deaths this year, CDC records only two
    Pennsylvania health officials say four people have died from measles so far in 2026. The Centers for Disease Control and Prevention, however, lists only two measles deaths in its national count. T…
    STAT · 21d agoNeutral↗ source
  • STAT releases AI Prognosis newsletter on health tech leaders' policy discussions in Washington
    STAT's AI Prognosis newsletter issued a new edition that looks at what health technology executives are saying about policy issues in Washington. The piece was authored by Brittany Trang, a Ph.D.…
    STAT · 21d agoNeutral↗ source
  • FDA approves Egetis’ Emcitate for rare genetic disease as Novo secures Chinese weight-loss pill in $2.6 billion deal
    The U.S. Food and Drug Administration has granted approval to Egetis' Emcitate, a therapy targeting a rare genetic disorder. This marks a regulatory milestone for the company and patients awaiting…
    raps · 22d agoDealPositive↗ source
  • Lilly's triple-agonist retatrutide drives up to 18.8% weight loss, over half of patients fall below obesity threshold
    At the EASD Annual Meeting in Milan, Eli Lilly presented data on its triple‑agonist retatrutide. The trial involved participants with obesity and type 2 diabetes and showed weight reductions of up…
    Endpoints · 21d agoPositive readoutPositive↗ source
  • UniQure’s gene therapy still slows Huntington’s disease after four years, but benefit declines
    UniQure reported that its one‑time gene therapy, AMT‑130, continues to decelerate the progression of Huntington’s disease four years after being surgically delivered into patients' brains. A new a…
    STAT · 22d agoNegative readoutNegative↗ source
  • Zealand and Roche's amylin analog shows modest weight loss at middle dose, lagging behind Lilly's in Phase 2 trial
    Zealand and Roche reported new data from their Phase 2 obesity trial of an amylin analog at a recent conference. The earlier topline results in March had been viewed as disappointing. The updated…
    Endpoints · 21d agoNegative readoutNegative↗ source
  • Lawmakers ask Trump to reconsider rule that would tighten import of prescription drugs from Canada
    Congressional members are pressing the Trump administration to revisit a federal rule slated to take effect on Oct. 22 that would tighten how prescription medicines are imported from Canada and oth…
    STAT · 22d agoRegulatoryNegative↗ source
  • Beam Therapeutics sues Chinese scientists and firms YolTech, Serapha Bio over alleged gene-editing technology theft
    Beam Therapeutics, a Cambridge-based company developing CRISPR base editing therapies, has filed a lawsuit. The suit names two Chinese scientists and the biotech firms YolTech and Serapha Bio, acc…
    Endpoints · 22d agoNegative↗ source
  • PhRMA appoints former House Majority Leader Eric Cantor as new president and CEO
    Former House Majority Leader Eric Cantor has been selected to lead PhRMA, the industry trade group representing pharmaceutical companies. The announcement was made on Tuesday, following earlier re…
    Endpoints · 22d agoNeutral↗ source
  • Ascletis pursues oral IL-17A inhibitor for psoriasis as Invivyd readies COVID-19 filing
    Ascletis, a biotech listed in Hong Kong, is developing a small‑molecule IL-17A inhibitor in pill form to treat psoriasis. The company aims to challenge the current injectable therapies that target…
    Endpoints · 22d agoRegulatoryNeutral↗ source
  • Anthropic joins ARPA‑H clinical AI moonshot and will host a closed‑door health‑care event
    Anthropic, an artificial‑intelligence firm, announced it is joining a new clinical‑AI initiative launched by the U.S. Biomedical Advanced Research Projects Agency‑Health (ARPA‑H). The partnership…
    STAT · 22d agoNeutral↗ source
  • UniQure shares tumble as Huntington's gene therapy shows reduced benefit over time
    UniQure announced new follow-up data from its experimental gene therapy for Huntington's disease, indicating the treatment's effect may diminish with longer observation. The additional year of dat…
    Endpoints · 22d agoNegative readoutNegative↗ source
  • AstraZeneca commits $2 billion to partner Summit Therapeutics on bispecific cancer antibody
    AstraZeneca has announced a $2 billion investment to work with Summit Therapeutics. The deal will fund the testing of Summit’s bispecific antibody, ivonescimab, which targets both PD‑1 and VEGF pat…
    STAT · 22d agoDealPositive↗ source
  • Novo to pay up to $2.6 billion for rights to Hengrui’s experimental weekly obesity pill
    Novo Pharmaceuticals has signed a licensing agreement with China's Hengrui Pharma to acquire an experimental oral weight‑loss drug that is administered once a week. Under the deal, Novo could pay…
    STAT · 22d agoDealNeutral↗ source
  • ARCH Venture Partners and Population Health Partners launch China-based sleep-disorder startup Somnivera
    ARCH Venture Partners and Population Health Partners have teamed up again to create a new China-focused biotech, Somnivera, aimed at developing therapies for sleep disorders. The partnership follo…
    Endpoints · 22d agoDealPositive↗ source
  • Fresenius Kabi partners with Waltz Health to sell biosimilars directly to employer health plans
    Fresenius Kabi announced it will begin selling biosimilar medicines directly to employer-sponsored health plans. The company is working with Waltz Health, a marketplace owned by Eversana, to help…
    Endpoints · 22d agoDealPositive↗ source