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  • 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
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  • 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
  • SNAP cuts risk increasing child separations, advocates warn
    The latest round of SNAP reductions, the biggest in the program’s history, has already left roughly 1.5 million children without food assistance. Studies cited by the authors suggest that losing t…
    STAT · 22d agoNegative↗ source
  • STAT+: PhRMA taps Eric Cantor as new CEO
    Eric Cantor, a former GOP House majority leader, is taking the helm of PhRMA at a challenging time for the industry.
    STAT · 22d ago↗ source
  • UniQure crashes as Huntington’s gene therapy shows less slowing of disease at 4 years
    The results are nevertheless “unprecedented,” UniQure executives said on an investor call Tuesday, emphasizing that the updated natural history database used as the control group for the Phase 1/2…
    BioSpace · 22d ago↗ source
  • Merck pulls Recarbrio antibiotic from U.S. market, raising concerns over superbug resistance
    Merck announced it has stopped supplying Recarbrio in the United States earlier this month. Recarbrio, a three‑drug combination injection approved seven years ago, is used for severe infections su…
    STAT · 23d agoNegative↗ source
  • AbbVie receives FDA approval for Parkinson’s drug Juvmo, a Cerevel acquisition asset
    AbbVie has secured FDA approval for tavapadon, marketed as Juvmo, for the treatment of Parkinson’s disease in adults. The decision follows positive results from the Phase 3 TEMPO trial. In the piv…
    BioSpace · 23d agoApprovalPositive↗ source
  • Kodiak Sciences' zenkuda and tabirafusp-ted match Eylea in Phase 3, sending stock up 166%
    Kodiak Sciences announced Phase 3 results for two investigational eye‑disease drugs, zenkuda (anti‑VEGF antibody biopolymer conjugate) and tabirafusp‑ted (anti‑IL‑6/VEGF bispecific), which performe…
    BioSpace · 23d agoPositive readoutPositive↗ source
  • Mirum receives FDA approval for Atebrioz, third therapy for ultra-rare bone disease FOP
    Mirum Pharmaceuticals announced that the U.S. Food and Drug Administration approved its ALK2 inhibitor, zilurgisertib, to be marketed as Atebrioz, for the treatment of fibrodysplasia ossificans pro…
    BioSpace · 23d agoApprovalPositive↗ source
  • Merck signs up to $2.13 billion deal with SciBrunch for preclinical KRAS inhibitor SPR2015
    Merck announced it has completed a deal with Chinese biotech SciBrunch Therapeutics, paying $400 million upfront for exclusive global rights to develop, manufacture and commercialize SciBrunch’s pr…
    BioSpace · 23d agoDealPositive↗ source
  • Novo Nordisk rebrands GLP-1 therapy Wegovy as weight-loss product, positioning it as lifestyle drug
    GLP-1 drugs have transformed the lives of millions and were originally promoted as medicines for obesity, a medical condition. Recent advertising campaigns are now presenting these drugs as genera…
    STAT · 23d agoNeutral↗ source