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  • CMS GLP-1 pilot shows early uptake and health benefits for seniors, signaling broader weight-loss drug access
    CMS launched a federal pilot program to expand access to GLP-1 weight-loss medications for seniors. After about two months, early data show that enrollment is rising and participants report improv…
    Endpoints · 16d agoRegulatoryPositive↗ source
  • Outer Bio unveils skin‑tissue platform that keeps samples alive for a month, creating terabytes of data for skincare research
    Outer Bio, a new biotech founded by Michael Polansky, has emerged from stealth to offer a skin‑focused platform that maintains harvested human skin tissue alive for about a month. The company says…
    BioPharma Dive · 16d agoPositive↗ source
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  • Hospitals Prepare Lobbying Effort to Counter $1 Trillion Health Care Funding Cuts
    Hospitals are gearing up to lobby Congress after a projected $1 trillion reduction in health‑care spending, which was part of recent tax‑cut legislation. Hospital leaders say they will seek higher…
    STAT · 16d agoRegulatoryNegative↗ source
  • UK reduces drug rebate rate to 14.5% after a year of pharma pull-back, following US trade deal
    In September 2025, relations between the UK government and major pharmaceutical companies hit a low point when the government announced a steep increase in the share of sales of new branded medicin…
    Fierce Biotech · 16d agoRegulatoryNeutral↗ source
  • Moderna to raise $2 billion via convertible senior notes to fund oncology expansion and reduce debt
    Moderna announced it will issue $2 billion of convertible senior notes. The company says the financing will give it flexibility to invest in its growing oncology portfolio and to repay existing deb…
    Endpoints · 16d agoDealNeutral↗ source
  • Lonza appoints Samanta Cimitan as chief commercial officer as WuXi Biologics posts revenue surge
    Lonza said it will create a new chief commercial officer position and has selected Samanta Cimitan, the current chief executive of Celonic, to take the role on Jan. 1 next year. Cimitan will be re…
    Endpoints · 16d agoPositive↗ source
  • Vivace Therapeutics appoints Craig Gibbs as CEO and Ellen Lubman as chief business officer ahead of phase 3 mesothelioma trial
    Vivace Therapeutics announced two senior leadership appointments. Craig Gibbs, Ph.D., will serve as the company’s president and chief executive officer, while Ellen Lubman joins as chief business a…
    Fierce Biotech · 16d agoPositive↗ source
  • Osivax licenses GC Biopharma seasonal flu vaccine to develop combined OVX836-GC FLU shot
    Osivax has secured a non-exclusive license from GC Biopharma for its seasonal influenza vaccine, GC FLU, to pair with Osivax’s mid-phase candidate OVX836. OVX836 targets the conserved nucleoprotei…
    Fierce Biotech · 16d agoDealPositive↗ source
  • Proposed Biotech Investment National Security Act may protect US firms but contains loophole aiding Chinese competition
    A bipartisan bill called the Biotech Investment National Security Act (BINSA) has been introduced in Congress to expand federal oversight of biotechnology activities, from drug development to biolo…
    STAT · 16d agoRegulatoryNegative↗ source
  • Akeso CEO says biliary tract cancer data could be a breakthrough
    Akeso’s chief executive Michelle Xia told ChinaPharma that the company’s PD-1xVEGF bispecific antibody, ivonescimab, is generating strong interest after early biliary tract cancer results. She not…
    Endpoints · 16d agoPositive↗ source
  • DEA moves on kratom substances as FDA greenlights new pancreatic drug
    The Drug Enforcement Administration is taking new steps concerning substances associated with kratom, signaling a shift in how the agency handles the plant-derived compounds. In a separate develop…
    STAT · 16d agoRegulatoryNeutral↗ source
  • Metriport secures $26 million Series A to streamline doctor access to patient data
    Metriport, a health-tech startup focused on simplifying how physicians obtain patient information, announced a $26 million Series A financing. The round was led by Matrix, with participation from…
    Endpoints · 16d agoDealPositive↗ source
  • CMS to host launch event for ACCESS, its new Medicare chronic care pilot
    CMS announced it will hold a launch event for ACCESS, a pilot program aimed at chronic care management for Medicare beneficiaries. The pilot is intended to test new care coordination models and pa…
    STAT · 16d agoRegulatoryNeutral↗ source
  • FDA review highlights expanding role of manufacturing process models in drug applications
    The FDA released a review outlining how manufacturers can incorporate process modeling into their regulatory submissions. Process models are described as a growing scientific area and are being us…
    raps · 16d agoRegulatoryNeutral↗ source
  • Generate:Biomedicines shares early Phase 1 respiratory data after ERS poster leak
    Generate:Biomedicines presented Phase 1 data for its respiratory disease candidate at the European Respiratory Society annual meeting. The presentation came after the conference posters were releas…
    Endpoints · 16d agoNeutral↗ source
  • Reddit reveals menopause symptoms often misdiagnosed, urging researchers to listen
    A University of Maryland researcher examined discussions on Reddit where women described perimenopause and menopause experiences that were frequently dismissed or misdiagnosed by clinicians. The on…
    STAT · 16d agoNeutral↗ source
  • Louisiana directs 20% of opioid settlement funds to sheriffs, who spend millions on police equipment
    KFF Health News investigated how Louisiana sheriffs used their share of opioid settlement money. The state allocated 20% of the settlement payouts to the 64 elected sheriffs, the largest law‑enfor…
    STAT · 16d agoNegative↗ source
  • MHRA revises guidance on periodic safety update reports for UK products
    The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an update to its pharmacovigilance procedures guidance. The revision focuses on the preparation and submission of periodic…
    raps · 16d agoRegulatoryNeutral↗ source
  • Former Stanford president posts emails to counter fraud claims in new book
    Former Stanford president Marc Tessier-Lavigne has posted a more than 3,000-word response on his lab website, including emails with former colleagues, to dispute claims that he fabricated research…
    STAT · 16d agoNegative↗ source
  • FDA considers new deputy commissioner roles as Trump prepares to announce additional MFN drug pricing agreements
    The Food and Drug Administration is evaluating the establishment of new deputy commissioner positions to support its expanding portfolio of responsibilities. The proposal reflects ongoing efforts…
    raps · 16d agoRegulatoryNeutral↗ source
  • Documents show RFK Jr. sought to study Samoa’s MMR vaccines despite claiming his 2019 visit was unrelated to vaccines
    Health secretary Robert F. Kennedy Jr. told lawmakers that his 2019 trip to Samoa had nothing to do with vaccines. New documents obtained by the Associated Press and The Guardian include a letter…
    STAT · 16d agoRegulatoryNegative↗ source
  • Venture investor Redesign Health shifts from studio model to firm amid AI-driven startup boom
    AI is allowing founders to launch companies faster, challenging traditional venture studios that create ideas internally. Redesign Health, known for its studio approach, is changing its strategy,…
    Endpoints · 16d agoNeutral↗ source
  • FDA approves Revolution Medicines' Rasonque for metastatic pancreatic cancer
    Revolution Medicines received FDA approval for its oral RAS inhibitor daraxonrasib, branded as Rasonque, to treat patients with metastatic pancreatic adenocarcinoma who have already received prior…
    Fierce Biotech · 17d agoApprovalPositive↗ source
  • FDA grants rapid approval to Revolution Medicines' pancreatic cancer drug Rasonque
    FDA approved Revolution Medicines' pancreatic cancer therapy Rasonque, just over a month after submission using a priority review voucher. The drug, formerly known as daraxonrasib, is for patients…
    BioPharma Dive · 17d agoApprovalPositive↗ source
  • FDA approves Rasonque, first therapy targeting genetic cause of advanced pancreatic cancer
    The U.S. Food and Drug Administration has granted approval to Rasonque, a drug from Revolution Medicines, for patients with advanced pancreatic cancer. The medicine, whose generic name is daraxonra…
    STAT · 17d agoApprovalPositive↗ source