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  • 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 · 2mo 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 · 2mo agoPositive↗ source
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Endocrinology & Metabolism775
Nephrology760
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 · 2mo 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 · 2mo agoRegulatoryNegative↗ source
  • Medtronic and Given Imaging issue early alert for Bravo CF esophageal pH capsule delivery devices due to attachment failures
    The FDA's Center for Devices and Radiological Health issued an Early Alert about a potential high‑risk issue with Medtronic’s Bravo CF esophageal pH monitoring capsule delivery devices. The proble…
    fda medwatch · 2mo 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 · 2mo 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 · 2mo 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 · 2mo agoDealPositive↗ source
  • AVID Medical issues correction for convenience kits containing recalled Medline Namic Star Off-Handle manifolds
    AVID Medical has sent a letter to customers directing a correction of certain convenience kits that include manifolds affected by the Medline Namic Angiographic Star Off-Handle manifold recall. Th…
    fda medwatch · 2mo agoCRLNegative↗ 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo agoNegative↗ 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 · 2mo agoNegative↗ 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo agoApprovalPositive↗ source
  • FDA approves Rasonque, first-in-class RAS inhibitor for metastatic pancreatic cancer
    The U.S. Food and Drug Administration has approved Rasonque (daraxonrasib), a RAS inhibitor, for the treatment of metastatic pancreatic adenocarcinoma. Rasonque is a tablet taken once daily that t…
    fda press · 2mo agoApprovalPositive↗ source
  • FDA approves Revolution Medicines' daraxonrasib for second-line pancreatic cancer
    The U.S. Food and Drug Administration announced approval of Revolution Medicines' drug daraxonrasib for patients with pancreatic cancer who have already received prior therapy. The approval marks…
    Endpoints · 2mo agoApprovalPositive↗ source
  • Experimental drugs to lower Lp(a) move toward market, promising billions in potential sales
    High levels of lipoprotein(a), or Lp(a), are a genetic risk factor for heart disease that affects roughly one in five people and currently has no approved therapy. Several drugmakers are moving ex…
    STAT · 2mo agoPositive↗ source
  • Biohaven secures up to $795 million partnership with SK Biopharma for global epilepsy drug rights
    Biohaven announced a commercial partnership for its late-stage epilepsy program. South Korea-based SK Biopharma has agreed to pay up to $795 million for worldwide rights to the company's Kv7 ion ch…
    Endpoints · 2mo agoDealPositive↗ source
  • Hansoh says China’s biopharma is shifting from follower to frontrunner, now behind 30% of investigational drugs
    Hansoh Pharmaceutical used its first‑half earnings release to claim that China’s innovative biopharma sector is moving from a follower role to a frontrunner position. The company highlighted that…
    Fierce Biotech · 2mo agoEarningsPositive↗ source
  • Spyre Therapeutics cuts rheumatoid arthritis program after weak Phase 2 TL1A antibody results
    Spyre Therapeutics reported that its Phase 2 study of the anti‑TL1A antibody SPY072 in rheumatoid arthritis did not meet the efficacy expectations set earlier this year. The company said the data f…
    Fierce Biotech · 2mo agoNegative readoutNegative↗ source
  • SK Biopharma signs $795 million licensing deal with Biohaven for epilepsy therapy opakalim
    SK Biopharma has entered a licensing agreement with Biohaven Pharmaceuticals to acquire worldwide rights to the Kv7 ion channel activator opakalim (BHV-7000) for epilepsy. The deal provides an upf…
    Fierce Biotech · 2mo agoDealPositive↗ source