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  • STAT+: Trump expected to pick White House adviser Heidi Overton to lead FDA
    Heidi Overton, a doctor and White House adviser, is expected to be President Trump's pick to lead the FDA.
    STAT · 1h ago↗ source
  • Eyepoint’s Phase 3 trial for age‑related blindness treatment fails primary endpoint, jeopardizing approval plans
    Eyepoint announced that its Phase 3 trial of the experimental drug Duravyu for a common cause of age‑related blindness did not meet its primary endpoint. Patients receiving the investigational ther…
    STAT · 13h agoNegative readoutNegative↗ source
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Amylyx avexitide cuts serious low blood sugar events by 55% in Phase 3 trial for post bariatric hypoglycemia
Amylyx Pharmaceuticals reported that its experimental drug avexitide significantly reduced the frequency of serious low blood sugar episodes in a Phase 3 study of patients with post‑bariatric hypog…
STAT · 15h agoPositive readoutPositive↗ source
  • Academic groups sue DHS over new four-year visa limit for foreign graduate students and postdocs
    Groups representing universities and educators filed a lawsuit in U.S. District Court in Massachusetts against the Department of Homeland Security. The suit challenges a new DHS rule that would re…
    STAT · 6h agoRegulatoryNegative↗ source
  • Amylyx reports positive pivotal trial results for drug targeting post-bariatric hypoglycemia
    Amylyx announced that its experimental therapy achieved statistically significant improvement in patients who experience severe hypoglycemia after bariatric surgery. The company said the pivotal t…
    STAT · 8h agoPositive readoutPositive↗ source
  • Municipalities and States Grapple with Rising Health-Insurance Costs and Upcoming Medicaid Drug Pricing Deadline
    Municipalities across the country are reporting that the cost of providing health insurance to their employees is becoming increasingly unsustainable, putting pressure on local budgets. States are…
    STAT · 11h agoRegulatoryNegative↗ source
  • FDA releases discussion paper seeking input on regulation of generative AI medical devices
    The U.S. Food and Drug Administration issued a discussion paper outlining considerations for regulating generative AI-enabled medical devices and asked stakeholders to provide feedback. The paper…
    fda press · 12h agoRegulatoryNeutral↗ source
  • LEO Pharma spends $435 million to acquire rare-disease skin drug dersimelagon
    LEO Pharma announced it will pay $435 million to buy the rights to dersimelagon, an oral MC1R agonist originally developed by Tanabe Pharma. The drug has completed Phase 3 trials for two rare phot…
    BioSpace · 13h agoDealPositive↗ source
  • GenBio AI launches AIDO Cell, a virtual model that simulates whole-cell behavior
    GenBio AI, a Palo Alto startup, unveiled AIDO Cell, a virtual cell platform that lets researchers view a cell’s interior like a map. The system visualizes proteins, RNA and DNA and can simulate gen…
    STAT · 13h agoPositive↗ source
  • Biotech funding rebound set to boost CDMO demand by early 2027
    Analysts note that demand for pharma services has historically lagged behind biotech funding, but a recent surge in venture capital is expected to drive activity for contract development and manufa…
    BioSpace · 13h agoPositive↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial after safety concerns
    Regeneron announced termination of a Phase 1/2 study of its investigational anti-inflammatory antibody REGN7041, which was being evaluated for non-infectious uveitis. The company said the decision…
    BioSpace · 15h agoNegative↗ source
  • Regeneron halts Phase 1/2 uveitis antibody trial over unfavorable risk-benefit profile
    Regeneron has stopped a Phase 1/2 study of its anti‑inflammatory antibody REGN7041 in non‑infectious uveitis, citing an unfavorable benefit‑risk assessment. The antibody targets CD3 on immune cell…
    BioSpace · 15h agoNegative readoutNegative↗ source
  • Amylyx to seek FDA approval for avexitide after Phase 3 success in post-bariatric hypoglycemia
    Amylyx announced plans to file a new drug application for avexitide, a GLP-1 receptor antagonist, after a Phase 3 trial showed reduction in serious hypoglycemia in patients who had gastric bypass s…
    BioSpace · 15h agoRegulatoryPositive↗ source
  • Enveda reports promising Phase 1 data for oral drug that mimics exercise to preserve muscle during weight loss
    Enveda, a biotech based in Boulder, Colorado, announced Phase 1 results for its oral candidate ENV-308, a chemically engineered version of the metabolite lactate phenylalanine (lac-phe). The metabo…
    STAT · 16h agoPositive readoutPositive↗ source
  • Study shows antibiotic overuse is concentrated in high-income nations, while low-income countries struggle with shortages
    Peter Beyer, deputy executive director of the Global Antibiotic Research & Development Partnership, writes an opinion piece highlighting a shift in how antimicrobial resistance is framed across the…
    STAT · 18h agoNeutral↗ source
  • Former NIAID adviser David Morens pleads guilty to concealing records and defrauding government
    David Morens, a former top National Institute of Allergy and Infectious Diseases official and longtime senior adviser to former NIAID leader Anthony Fauci, entered a guilty plea on Tuesday on charg…
    STAT · 5h agoRegulatoryNegative↗ source
  • Sandoz inks $322M Henlius deal for rights to as many as 10 biosimilars
    The initial batch of biosimilars includes copies of Amgen, Eli Lilly and GSK drugs that collectively generate billions of dollars in annual revenues.
    BioSpace · 12h agoDealNeutral↗ source
  • AI and data sharing essential for safer cell and gene therapies, says industry leader
    The author argues that keeping data secret in cell and gene therapy harms patients, and that a commitment to transparency and artificial intelligence is needed to make these treatments safer and mo…
    BioSpace · 22h agoPositive↗ source
  • BD advises recall of sodium chloride ampules in convenience kits after Huons Co. issue
    The FDA issued an Early Alert after Becton Dickinson (BD) sent a letter to customers about a potential high‑risk device issue. The alert concerns convenience kits and procedural trays that contain…
    fda medwatch · 22h agoRegulatoryNegative↗ source
  • Study highlights limits of premarket evaluation for identifying recalls of high-risk medical devices
    More than one-third of high-risk therapeutic medical devices approved over the last decade were subject to serious recalls, but the lack of consistent characteristics of these recalled devices sugg…
    raps · 1d agoRegulatoryNeutral↗ source
  • White House touts record drug-price drop, but critics say the claim oversimplifies the data
    The administration highlighted a recent Consumer Price Index report showing prescription drug prices fell 3.1% over the 12 months ending in July, the steepest annual decline since 1963, and dropped…
    STAT · 7h agoRegulatoryNegative↗ source
  • Kindergarten vaccine exemptions rise as Doritos marketing sparks food-health debate
    A recent Morning Rounds briefing highlighted that exemptions for childhood vaccines are increasing in kindergarten classrooms, raising concerns among public health observers. The same report also…
    STAT · 13h agoNeutral↗ source
  • Rising health-care costs force Pennsylvania county to raise property taxes by 22%
    Bob Herman interviewed state and local officials, health policy experts, and industry executives about the growing burden of health‑care expenses for government workers. The investigation found tha…
    STAT · 18h agoNegative↗ source
  • Mass General and Dana-Farber CEOs receive record compensation in 2024 amid hospital cost pressures
    Newly released compensation records show that chief executives of major Massachusetts health systems earned substantially higher pay in 2024. Dr. Anne Klibanski, the CEO of Mass General Brigham, t…
    STAT · 9h agoNegative↗ source
  • Bon Secours Mercy Health receives $1.1 billion from Ensemble Health Partners stake in 2026
    Bon Secours Mercy Health, a nonprofit system based in Cincinnati, reported that it has collected more than $1 billion in cash this year from its minority stake in Ensemble Health Partners, a medica…
    STAT · 5h agoDealPositive↗ source