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  • 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 · 2d agoNeutral↗ source
  • FDA issues draft guidance for generative AI medical devices as industry calls for German drug pricing reform
    The U.S. Food and Drug Administration has published a draft guidance document that outlines the agency's expectations for medical devices that incorporate generative artificial intelligence. The dr…
    raps · 2d agoRegulatoryNeutral↗ source
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  • 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 · 1d 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 · 2d 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 · 2d agoPositive↗ source
  • FDA updates guidance to clarify ANDA and 505(b)(2) approval pathways
    The FDA released a draft guidance that updates a seven-year-old document on abbreviated drug approval pathways. The guidance clarifies the distinction between traditional Abbreviated New Drug Appl…
    raps · 2d agoRegulatoryNeutral↗ 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 · 2d 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 · 1d 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 · 2d 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 · 2d agoNegative↗ source
  • Study finds measuring non-clinical influences on FDA approvals is complex
    A new study examined how non-clinical factors might affect the U.S. Food and Drug Administration's drug approval decisions. Researchers concluded that quantifying such influences is challenging be…
    raps · 2d agoRegulatoryNeutral↗ source
  • Drug makers and animal testing groups urge FDA to keep flexible guidance on animal studies for cancer drugs
    A coalition of drug developers, regulators and laboratory animal-testing organizations has asked the U.S. Food and Drug Administration to keep its guidance on cancer-drug safety studies flexible.…
    raps · 2d agoRegulatoryNeutral↗ 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 · 1d 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 · 1d agoDealPositive↗ source
  • Opinion warns US surrogacy system is chaotic and may face bans after decades of legal battles
    Arthur Caplan writes that the United States surrogacy framework is poorly managed, using the recent West case as a warning sign. He argues that the lack of clear rules could lead to broader bans.…
    STAT · 2d agoNegative↗ source
  • Doritos market themselves as farm-to-table despite being ultra-processed, highlighting industry image push
    Doritos' latest ads portray the nacho cheese snack as a farm-to-table product, showing corn seedlings and a farmer in a PepsiCo hat and claiming a partnership with farmers to bring the chips from f…
    STAT · 2d agoNegative↗ source
  • FDA approves Zenbexus for multiple myeloma as NSAI looks to sell MDR notified body unit
    The U.S. Food and Drug Administration has granted approval for Zenbexus to be used in the treatment of multiple myeloma, marking a new therapeutic option for patients with this blood cancer. The a…
    raps · 3d agoApprovalPositive↗ source
  • Eyepoint's wet AMD therapy misses primary goal in Phase 3, stock tumbles
    Eyepoint reported that its experimental drug Duravyu did not keep vision in patients with wet age-related macular degeneration when given less frequently than the standard of care, causing the Phas…
    STAT · 2d agoNegative readoutNegative↗ source
  • Slate Medicines secures $245M financing and Nasdaq listing via reverse merger with Fulcrum Therapeutics
    Slate Medicines, a North Carolina biotech, is moving toward a Nasdaq listing through a reverse merger with Fulcrum Therapeutics, six months after emerging from stealth. The transaction includes a…
    Fierce Biotech · 3d agoDealPositive↗ source
  • Sanofi to cut 229 Massachusetts jobs a year after $9.1 billion Blueprint Medicines acquisition
    Sanofi announced it will lay off 229 employees in Massachusetts, according to a filing with the state's Executive Office of Labor and Workforce Development. The workers are from Blueprint Medicine…
    STAT · 2d agoLayoffsNegative↗ source
  • Amylyx's avexitide halves hypoglycemia episodes in phase 3 trial for post‑bariatric patients
    Amylyx Pharmaceuticals reported that its GLP‑1 receptor antagonist avexitide significantly reduced dangerous blood‑sugar drops in a phase 3 study. The double‑blind Lucidity trial enrolled 78 indiv…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source
  • IRS probes UnitedHealth tax filings and private-equity deals for doctor groups slow down
    UnitedHealth disclosed that the IRS has opened an investigation into its tax filings for 2017-2020, seeking to increase the company’s taxable income and potentially raise its tax bill for those yea…
    STAT · 3d agoRegulatoryNegative↗ source
  • EyePoint’s Phase 3 trial of duravyu fails to outperform aflibercept, shares plunge 70%
    EyePoint announced that its Phase 3 Lugano trial of the investigational tyrosine kinase inhibitor duravyu did not meet the primary efficacy endpoint when compared with the standard‑of‑care anti‑VEG…
    BioSpace · 3d agoNegative readoutNegative↗ source
  • Summit Therapeutics and Akeso celebrate third China approval for ivonescimab as new data show waning survival benefit
    Summit Therapeutics and its partner Akeso received a third approval in China for ivonescimab, a PD-1/VEGF bispecific antibody, for first-line treatment of advanced squamous non-small cell lung canc…
    BioSpace · 3d agoRegulatoryNegative↗ source
  • Akeso and Summit’s lung cancer candidate shows worsening tumor progression, while Europe halts Tavneos over trial concerns
    Akeso Therapeutics and Summit Therapeutics reported that their combined lung cancer therapy failed to improve outcomes, with data indicating a worsening in tumor progression compared to control. T…
    STAT · 3d agoNegative readoutNegative↗ source