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  • Moderna and Merck vaccine plus Keytruda cuts melanoma relapse risk by 42% in late-stage trial
    A late-stage adjuvant study of Moderna’s experimental melanoma vaccine, intismeran autogene, combined with Merck’s Keytruda showed a 42% reduction in the risk of relapse or death compared with Keyt…
    BioPharma Dive · 18d agoPositive readoutNeutral↗ source
  • Moderna and Merck's mRNA melanoma vaccine cuts recurrence risk by 42% in trial
    A large Phase 2 trial led by Moderna and Merck showed that their personalized mRNA vaccine, intismeran autogene, lowered the chance of melanoma returning by 42% compared with standard therapy. The…
    STAT · 18d agoPositive readoutPositive↗ source
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  • U.S. proposes rule tightening review of biotech licensing deals with Chinese firms
    The U.S. is preparing to issue a proposed rule that would place additional scrutiny on outbound licensing agreements between American biotech firms and Chinese companies. The measure aims to increa…
    STAT · 18d agoRegulatoryNeutral↗ source
  • FDA launches Neuroscience Advancement and Innovation Nexus to boost brain disorder drug development
    The U.S. Food and Drug Administration announced a new program called the Neuroscience Advancement and Innovation Nexus (NAIN) aimed at accelerating the development of medical products for brain and…
    fda press · 18d agoRegulatoryPositive↗ source
  • FDA accepts new submission for Biohaven’s Vyglxia, opening path to approval
    Biohaven announced that the FDA has accepted a refreshed application for its rare disease drug Vyglxia, which targets a nerve‑damaging disorder. Vyglxia is being developed for spinocerebellar atax…
    BioPharma Dive · 18d agoRegulatoryPositive↗ source
  • Compounding pharmacy recalls copycat version of Eli Lilly’s Zepbound amid safety concerns
    Apothecary Pharma, a compounding pharmacy, has voluntarily recalled its compounded tirzepatide product that mimics Eli Lilly's obesity drug Zepbound. The company said it could not guarantee the saf…
    BioPharma Dive · 18d agoCRLNegative↗ source
  • Roche reaffirms sales outlook despite weaker Xolair sales and looming generic competition
    Roche reported third-quarter group sales of 16.1 billion Swiss francs, about $19.6 billion, a 7% increase that beat analysts' consensus estimate of 15.8 billion francs. The beat was helped by a ne…
    BioPharma Dive · 18d agoEarningsNegative↗ source
  • FDA issues final guidance on drug-related mobile applications
    The FDA has released its final guidance addressing software applications that are used in connection with prescription drugs. The guidance clarifies how the agency will evaluate and regulate apps…
    STAT · 18d agoRegulatoryNeutral↗ source
  • AbbVie’s lutikizumab meets primary endpoint in Phase 3 hidradenitis trial but falls short of market expectations
    AbbVie announced that its experimental drug lutikizumab achieved its primary goal in a Phase 3 study of hidradenitis suppurativa, a chronic inflammatory skin disease. The Intrepid trial enrolled a…
    STAT · 18d agoPositive readoutNegative↗ source
  • Treasury rumored to consider rule limiting U.S. investment in Chinese biotech
    A report says the U.S. Treasury is expected to propose a regulation that would curb American investment in China’s biotech sector. The story notes the proposal is still a rumor and no formal rule h…
    STAT · 18d agoRegulatoryNeutral↗ source
  • Moderna and Merck prepare to unveil cancer vaccine data at ESMO Congress
    Adam Feuerstein reports from the European Society for Medical Oncology meeting in Madrid that the long‑awaited data from the Moderna‑Merck cancer vaccine partnership will be presented in the coming…
    STAT · 18d agoNeutral↗ source
  • Telehealth platforms prescribe GLP-1 drugs off-label for addiction, raising safety concerns
    Telehealth companies have begun prescribing GLP-1 receptor agonists, originally approved for diabetes and obesity, to patients with alcohol, cocaine, methamphetamine or other substance use disorder…
    STAT · 19d agoNeutral↗ source
  • U.S. health insurance premiums rise 9% as uninsured numbers climb, while telehealth firms explore GLP-1 drugs for addiction
    A new survey shows U.S. health insurance premiums increased by 9%, pushing more working‑age adults without coverage in 2026. The rise in costs coincides with a growth in the number of people lackin…
    STAT · 19d agoNegative↗ source
  • Workers face 9% rise in family health insurance premiums in 2026, KFF survey shows
    A new KFF Employer Health Benefits Survey shows that the average cost workers pay for family health insurance jumped 9% in 2026, reaching $7,471 per year. This increase outpaces the 6% and 7% rises…
    STAT · 19d agoNegative↗ source
  • Gilead Sciences to Pay $45 Million to Settle Texas Medicaid Kickback Allegations
    Gilead Sciences has agreed to pay $45 million to settle claims by the Texas attorney general that the company provided illegal kickbacks that influenced prescriptions covered by Texas Medicaid. Th…
    STAT · 18d agoRegulatoryNegative↗ source
  • Nutrition experts urge White House to release ultra-processed food definition before midterms
    More than 80 nutrition researchers and experts have signed a petition urging the White House to make public the federal government’s proposed definition of ultra-processed foods. The group says the…
    STAT · 18d agoRegulatoryNeutral↗ source
  • Health policy crackdown warnings span from China to New York, says STAT newsletter
    STAT's D.C. Diagnosis newsletter highlights growing concerns about health policy crackdowns that could affect regions from China to New York. In a recent Ohio appearance, the vice president used a…
    STAT · 18d agoNeutral↗ source
  • Family's unnamed inherited disease finally identified, offering hope for future generations
    Miranda Pappas, a research methodologist, describes how an inherited condition affected several generations of her family without ever having a formal name. Doctors repeatedly referred to the illn…
    STAT · 19d agoPositive↗ source
  • Top MAHA adviser Calley Means resigns from White House ahead of midterm elections
    Calley Means, a senior adviser for the Make America Healthy Again (MAHA) initiative in the Trump administration, announced his resignation from the White House. Means had served first as a close a…
    STAT · 18d agoNeutral↗ source
  • Economist admits misreading ACA's cost-control promise and calls for reforms
    Dana P. Goldman, director of the USC Schaeffer Institute, recalls signing a 2009 letter with other economists urging Congress to pass the Affordable Care Act. He supported the bill because it promi…
    STAT · 19d agoNegative↗ source
  • Natural Grocers recalls 2‑pound organic mung beans over possible glass contamination
    Vitamin Cottage Natural Food Markets, Inc. in Lakewood, Colorado announced a recall of Natural Grocers brand organic 2‑pound mung beans because of potential glass contamination. The recall follows…
    fda recalls · 18d agoRegulatoryNegative↗ source
  • WinCo Foods recalls hoagie rolls after undisclosed sesame ingredient
    WinCo Foods of Boise, Idaho announced a recall of its brand hoagie rolls because sesame was not listed on the label. The rolls, identified by UPC 2-70552-00649-2 and bearing best-by dates from Sep…
    fda recalls · 18d agoCRLNeutral↗ source
  • GSK and Ionis receive FDA nod for Hibsago, a potential functional cure for chronic hepatitis B
    The U.S. Food and Drug Administration has cleared Hibsago, a collaborative product of GSK and Ionis, as the first therapy of its kind aimed at chronic hepatitis B. The medicine is to be added to s…
    BioPharma Dive · 19d agoApprovalPositive↗ source
  • GSK receives FDA approval for hepatitis B therapy that expands functional cure rates
    GSK announced that the U.S. Food and Drug Administration has granted approval for its hepatitis B drug. The agency said the treatment can achieve functional cures in a larger proportion of patient…
    STAT · 19d agoApprovalPositive↗ source
  • Roivant's brepocitinib shows strong Phase 3 results, paving way for uveitis indication
    Roivant subsidiary Priovant Therapeutics announced positive Phase 3 data for its anti‑inflammatory drug brepocitinib in patients with non‑infectious uveitis, an eye disease that can cause blindness…
    BioPharma Dive · 19d agoRegulatoryPositive↗ source