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  • 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
  • Biopharma needs to reward scientists' judgment
    It’s not enough for organizations to want scientists to think like entrepreneurs. They have to incentivize and reward for that behavior.
    BioSpace · 21d ago↗ source
  • FDA approves Egetis’ Emcitate for rare genetic disease as Novo secures Chinese weight-loss pill in $2.6 billion deal
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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
  • AstraZeneca invests $2 billion in Summit Therapeutics to fund Phase 3 trials of ivonescimab
    AstraZeneca has agreed to a $2 billion all‑stock investment in Summit Therapeutics. The deal involves the purchase of preferred shares that can be converted into common stock, but it does not inclu…
    BioSpace · 22d agoDealPositive↗ 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
  • Curium gains FDA nod for Bexlutry as it eyes challenge to Novartis radioligand therapies
    Curium recently received FDA approval for its radiopharmaceutical Bexlutry, positioning it as a direct competitor to Novartis’ Lutathera. The biotech is also in discussions with the FDA about fili…
    BioSpace · 22d agoApprovalNeutral↗ source
  • US charges two Indian nationals in counterfeit Ozempic distribution scheme
    The U.S. Attorney’s Office for the Middle District of Florida and the DOJ’s Criminal Division announced federal charges against Swapnadip Roy, 33, and Vicky Ramancha, 37, both Indian nationals, for…
    fda press · 21d agoRegulatoryNegative↗ 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 · 21d agoRegulatoryNegative↗ 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
  • Roche drops anti-myostatin obesity drug after mid-stage trial shows limited weight loss
    Roche announced it will stop development of its anti-myostatin obesity candidate emugrobart after an interim analysis of the Phase 2 GYMINDA trial showed it is unlikely to produce meaningful weight…
    BioSpace · 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
  • Novo Nordisk licenses weekly oral obesity peptide from Hengrui in up to $2.6 billion deal
    Novo Nordisk has signed a licensing agreement with China's Hengrui Pharma for a once‑weekly oral peptide, HRS‑1596, aimed at obesity and other metabolic conditions. Novo will pay $300 million upfr…
    BioSpace · 22d agoDealNeutral↗ source
  • Midterm elections could reshape drug pricing, Medicaid funding and research support, industry leaders warn
    The November midterm elections are set to influence major health-care policy debates in Washington, according to STAT+. Industry leaders say the outcome could affect Medicaid funding levels, the p…
    STAT · 22d agoRegulatoryNeutral↗ source
  • CMS ends automatic Medicare bonuses for FDA breakthrough devices
    CMS announced that beginning in October, devices carrying the FDA’s breakthrough designation will no longer receive automatic extra payments from Medicare. The change removes the special pathway th…
    STAT · 22d agoRegulatoryNegative↗ source
  • MAHA Institute pushes for broader health data sharing to aid research on chronic disease and autism
    At a recent event, the Make America Healthy Again (MAHA) Institute, linked to allies of Robert F. Kennedy Jr., argued that opening health records to federal researchers could accelerate studies of…
    STAT · 22d agoRegulatoryPositive↗ source
  • Regulators Discuss Plans to Streamline Europe’s Drug Approval Process at 2026 RAPS Convergence
    A panel of European regulators gathered at the 2026 RAPS Convergence in Charlotte, North Carolina to discuss ongoing initiatives aimed at simplifying the continent’s regulatory framework. The offi…
    raps · 22d agoRegulatoryNeutral↗ source
  • FDA releases draft guidance on requirements for robotically assisted surgical devices
    The FDA has published a draft guidance outlining its thinking on the requirements for bringing certain robotically assisted surgical devices to market. The guidance describes both non-clinical and…
    raps · 22d agoRegulatoryNeutral↗ source
  • Beam Therapeutics sues former scientist over alleged IP theft to launch Chinese biotech YolTech
    Beam Therapeutics, a Cambridge‑based gene‑editing company, has filed a lawsuit accusing a former scientist of stealing proprietary data. The complaint says Zi Jun "Emma" Wang accessed Beam's elect…
    STAT · 22d agoNegative↗ source
  • MAHA Summit Shows Grassroots Health Movement Aligning with Industry Leaders
    The recent MAHA Summit brought together federal officials and health‑care executives, marking a shift from the movement’s original grassroots stance. At a panel on affordability, leaders from Unit…
    STAT · 21d agoNegative↗ source
  • SK pharmteco hosts webinar on overcoming ADC linker-payload manufacturing challenges
    SK pharmteco’s European and North American teams presented a webinar that explored the full lifecycle of antibody‑drug conjugate (ADC) linker‑payload development, from facility design to final prod…
    BioSpace · 22d agoNeutral↗ source
  • Study finds blocking T cells entry into brain slows neurodegeneration in mice
    Researchers at Washington University in St. Louis reported that preventing certain immune cells, specifically T cells, from entering the brain reduced signs of neurodegeneration in a mouse model.…
    STAT · 22d agoPositive↗ source
  • Child health crisis threatens US national security, authors warn
    The authors argue that chronic illness, anxiety, depression and other health problems among children undermine future military readiness, the workforce and the nation’s global competitiveness. The…
    STAT · 22d agoNegative↗ source
  • FDA nominee Heidi Overton’s confirmation won’t be voted on before the midterm elections
    The Senate health committee is set to vote on three HHS leadership nominees on Wednesday, but the nomination for FDA commissioner Heidi Overton is not among them. Overton’s confirmation has been p…
    STAT · 22d agoNeutral↗ source
  • Sociologist finds vaccine-hesitant parents make logical choices, not anti-science
    Jennifer Reich, a sociologist at the University of Colorado, has spent about twenty years interviewing families who choose not to vaccinate their children. Reich, who herself follows the CDC sched…
    STAT · 22d agoNeutral↗ source