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  • Roche's KRAS inhibitor divarasib shows strong results in second-line lung cancer trial at ESMO
    Roche presented data from a trial of its KRAS G12C inhibitor divarasib at the European Society for Medical Oncology meeting. The study evaluated divarasib in patients with advanced non-small cell…
    STAT · 14d agoPositive readoutPositive↗ source
  • Amgen’s Imdelltra plus AstraZeneca’s Imfinzi cuts death risk by ~60% in extensive-stage small cell lung cancer
    Amgen presented Phase 3 data at ESMO 2026 showing that its bispecific T‑cell engager Imdelltra, when added to AstraZeneca’s checkpoint inhibitor Imfinzi, significantly reduced mortality in extensiv…
    BioSpace · 14d agoPositive readoutPositive↗ source
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  • Moderna and Merck aim to file personalized cancer vaccine for FDA approval after Phase 3 success
    Moderna CEO Stéphane Bancel said the company’s personalized cancer vaccine, intismeran, met its primary goals in a pivotal Phase 3 trial. The success was disclosed during an interview at the ESMO m…
    STAT · 14d agoPositive readoutPositive↗ source
  • Merck/Kelun ADC sac-TMT cuts death risk by one-third in advanced endometrial cancer
    A randomized Phase 3 trial showed that the antibody‑drug conjugate sacituzumab tirumotecan (sac‑TMT) reduced the risk of death by about one‑third in patients with advanced endometrial cancer. The…
    STAT · 14d agoPositive readoutPositive↗ source
  • Genmab’s Rina-S ADC cuts risk of progression and death in Phase 3 ovarian cancer trial
    Genmab reported results from its Phase 3 RAINFOL-02 trial of the FRα‑directed antibody‑drug conjugate Rina‑S (rinatabart sesutecan) in patients with platinum‑resistant ovarian cancer. In the inten…
    BioSpace · 14d agoPositive readoutPositive↗ source
  • GSK gains another cancer drug approval and unveils promising chemo data as it prepares for lung cancer approval
    GSK received regulatory approval this week for one of its cancer medicines in an additional tumor indication, expanding the portfolio that has grown since the company re-entered oncology a decade a…
    STAT · 14d agoApprovalPositive↗ source
  • Biotech IPOs Pull in $7.5B Across 22 Deals in 2026, While Market Gains Stall in Q3
    Biopharma companies raised about $7.5 billion from 22 initial public offerings in the first three quarters of 2026, according to J.P. Morgan data. This level of financing far exceeds the eight offe…
    BioSpace · 14d agoDealNeutral↗ source
  • Merck and Moderna's mRNA melanoma vaccine shows 42% risk reduction in Phase 3 trial, easing analyst concerns
    At the European Society of Medical Oncology meeting, Merck and Moderna presented data from their Phase 3 INTerpath-001 trial of a personalized mRNA vaccine combined with Keytruda in resected melano…
    BioSpace · 14d agoPositive readoutPositive↗ source
  • Incyte reports lasting tumor responses in pancreatic cancer patients using targeted drug plus chemotherapy
    Incyte announced at the European Society for Medical Oncology meeting that its targeted therapy, when combined with standard chemotherapy, produced durable tumor responses in a subset of pancreatic…
    STAT · 14d agoPositive readoutPositive↗ source
  • Moderna CEO Bancel optimistic after Phase 3 success of mRNA melanoma vaccine intismeran
    Moderna chief executive Stéphane Bancel said the company will move quickly to obtain FDA approval for its experimental melanoma therapy intismeran after a Phase 3 trial showed positive results. Th…
    STAT · 15d agoPositive readoutPositive↗ source
  • Taysha and Neurogene close in on first Rett syndrome gene therapy as 2027 readouts loom
    Two companies, Taysha Gene Therapies and Neurogene, are nearing the final stage of development for gene therapies targeting Rett syndrome, a rare neurodevelopmental disorder with limited treatment…
    BioSpace · 15d agoPositive readoutPositive↗ source
  • Bon Secours Mercy Health to Acquire Surgery Partners in $5.7 B Deal, Expanding Ambulatory Surgery Network
    Nonprofit Bon Secours Mercy Health announced it will buy Surgery Partners, a publicly traded operator of more than 200 ambulatory surgery centers, short-stay hospitals and physician practices. The…
    STAT · 14d agoDealPositive↗ source
  • U.S. biotechs capture 68% of global VC funding since 2025, led by Bay Area and Boston
    Since the start of 2025, U.S. biopharma firms have secured $37.2 billion in venture capital, representing about 68 % of the $54.5 billion raised worldwide. The San Francisco Bay Area and Boston do…
    BioSpace · 14d agoDealNeutral↗ source
  • House lawmaker probes PBMs over alleged punitive audits of independent pharmacies
    House Committee Chairman James Comer sent letters to CVS Caremark, OptumRx and Express Scripts alleging that independent pharmacies faced a sudden increase in audits after publicly supporting his P…
    STAT · 14d agoRegulatoryNegative↗ source
  • J&J's Halda-derived prostate cancer drug shows 75% response in early Phase 1 trial
    Johnson & Johnson's recent $3 billion purchase of Halda Therapeutics added an oral prostate cancer candidate, JNJ-6143, to its pipeline. The drug targets a cancer-specific protein to trigger cell d…
    BioSpace · 14d agoPositive readoutPositive↗ source
  • Health insurance premiums surge as CMS ramps up Medicaid fraud crackdown
    Premiums for health insurance are climbing sharply, putting pressure on both large and small employers. While many firms have absorbed the cost to stay competitive, smaller businesses are beginning…
    STAT · 14d agoRegulatoryNegative↗ source
  • Experts unveil four-stage framework for women's heart health across the lifespan
    Experts from the American Heart Association, American Academy of Pediatrics, Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists released a new framework…
    STAT · 15d agoPositive↗ source
  • Australian clinical trials attract more U.S. sponsors amid regulatory uncertainty
    CROs are reporting faster startup timelines, predictable regulation, and tax incentives as reasons for increasing interest in conducting clinical trials in Australia. State-level incentives in Que…
    BioSpace · 15d agoNeutral↗ source
  • FDA Commissioner Highlights New Rare Disease Framework Emphasizing Patient Voice
    Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas highlighted the agency's new rare disease framework during a fireside chat at the NORD Breakthrough Summit. The framework i…
    raps · 15d agoRegulatoryPositive↗ source
  • FDA clears Edwards' tricuspid valve repair device; Bayer's blood thinner asundexian approved in China
    The U.S. Food and Drug Administration has granted approval for Edwards Lifesciences' new tricuspid valve repair system, expanding treatment options for patients with tricuspid regurgitation. In Ch…
    raps · 15d agoApprovalNeutral↗ source
  • NIH launches vaccine injury center that will also study long-term post-infection symptoms
    NIH announced a new center dedicated to investigating vaccine injuries. The center's mandate expands to include research on persistent symptoms after infections, such as long Covid. Officials sai…
    STAT · 15d agoRegulatoryNeutral↗ source
  • HHS rolls back 14 security and privacy requirements for EHR certification
    The U.S. Department of Health and Human Services issued a final rule that removes 14 of the 60 criteria used to certify electronic health record (EHR) systems. The revisions affect security, priva…
    STAT · 14d agoRegulatoryNeutral↗ source
  • First human case of cow-associated Shamonda virus reported in France
    French health officials have confirmed that a person in France has become infected with the Shamonda virus, a pathogen that previously was known to affect cattle. The World Health Organization has…
    STAT · 14d agoNeutral↗ source
  • TGA opens consultation on temporary rise in Australian medical device annual fees
    The Therapeutic Goods Administration (TGA) in Australia announced a public consultation regarding a proposed temporary increase to the annual charges that medical device manufacturers must pay. Th…
    raps · 15d agoRegulatoryNeutral↗ source
  • Patient feels exhausted despite normal labs, highlighting stress and lifestyle factors
    A family nurse practitioner recounts a visit with a 43-year-old patient who complains that she no longer has the energy she had in her twenties. The doctor notes that all of the patient’s lab resu…
    STAT · 15d agoNegative↗ source