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  • Merck and Moderna report positive late-stage melanoma vaccine results, adding to 2026 cancer breakthrough year
    Merck and Moderna announced that their personalized mRNA neoantigen vaccine achieved positive outcomes in a late-stage trial for melanoma patients. The data suggest the vaccine can stimulate an imm…
    STAT · 2h agoPositive readoutPositive↗ source
  • Layoffs hit over 1,300 workers across seven biopharma M&A deals in 2026
    Workforce reductions this year have affected at least seven biopharma companies that recently completed mergers or acquisitions, eliminating a minimum of 1,359 jobs, according to BioSpace data. Th…
    BioSpace · 6h agoLayoffsNegative↗ source
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  • Capricor Therapeutics likely faces FDA rejection of its Duchenne cell therapy
    Capricor Therapeutics is working to avoid an imminent FDA rejection of its cell‑based treatment for Duchenne muscular dystrophy. The company says it remains confident in the drug, but the regulator…
    STAT · 2h agoRegulatoryNegative↗ source
  • Capricor’s Duchenne drug deramiocel receives negative FDA advisory vote on heart outcome
    Mindy Leffler, a parent of a young man with Duchenne muscular dystrophy, writes an opinion piece about Capricor’s phase 3 study of its drug deramiocel. She describes her son’s experience living ind…
    STAT · 4h agoRegulatoryNegative↗ source
  • Health systems deploy AI chatbots to streamline patient record review
    Several large health systems are rolling out generative AI chatbots that can query and summarize electronic medical records. Clinicians report that the tools save time and help uncover information…
    STAT · 4h agoPositive↗ source
  • Biotech firms EMD Serono and Exelixis cut remote R&D staff as they enforce office return policies
    Biopharma workers at two biotech companies are losing jobs as employers shift away from remote work. The changes affect research and development staff who were previously allowed to work from home.…
    BioSpace · 6h agoLayoffsNegative↗ source
  • Experts discuss persistent CMV challenges and new antiviral approaches for transplant patients
    In a recent episode of BioSpace's Denatured podcast, Ian McGowan, chief medical officer of Synklino, and James Hunter, an associate professor of transplantation at Oxford University, joined host Je…
    BioSpace · 2h agoNeutral↗ source
  • Pediatric rare cancer research draws steady investment despite biotech market volatility
    The article notes that pediatric rare cancers continue to attract investment because they address the greatest unmet medical needs and allow clear measurement of patient impact. Even as the biotec…
    BioSpace · 9h agoPositive↗ source
  • US allocates $2 billion to faith-based health groups, highlighting shift toward faith-driven capital in global aid
    The Trump administration this month announced a nearly $2 billion allocation for faith‑based organizations, the largest such commitment in over two decades. About $1.4 billion is earmarked for hea…
    STAT · 4h agoNeutral↗ source
  • Experts warn protein restriction could harm older adults and GLP-1 patients
    Researchers have recently suggested that limiting dietary protein might improve metabolic health and extend lifespan, a claim highlighted in a review paper in Cell Press Blue. Nutrition specialist…
    STAT · 4h agoNegative↗ source
  • Experts urge DSM to list muscle dysmorphia as eating disorder to improve care for men
    Males account for roughly one third of people in the United States who struggle with eating disorders, and many of these conditions begin in the teenage years. Some estimates suggest that as many a…
    STAT · 4h agoNeutral↗ source
  • STAT+: Pharmalittle: We’re reading about a Regeneron rare disease drug, an Ultragenyx gene therapy, and more
    A Regeneron drug for an ultra-rare disease that causes bone to grow where it shouldn't won U.S. regulatory approval, capping a three-decade effort
    STAT · 15m ago↗ source
  • Regeneron wins FDA approval to challenge Ipsen for rare bone disease market
    Regeneron’s Pasatru is the second fibrodysplasia ossificans progressiva drug approved in the U.S., following the 2023 approval of Ipsen’s Sohonos.
    BioSpace · 43m ago↗ source
  • Ultragenyx bags first gene therapy approval as previously rejected Sanfilippo asset awaits decision
    The accelerated greenlight for Ultragenyx’s gene therapy for glycogen storage disease has raised analyst expectations for approval of UX111, which the FDA rejected last summer and is currently revi…
    BioSpace · 1h ago↗ source
  • Merck’s Moderna-partnered vaccine success clears view of post-Keytruda future
    Investors had been pessimistic about the probability of success for the personalized cancer vaccine intismeran autogene, so the Phase 3 win was a welcome surprise.
    BioSpace · 1h ago↗ source
  • Merck and Moderna report success in late-stage trial of personalized mRNA cancer vaccine
    Merck and Moderna announced that their personalized mRNA cancer vaccine achieved its primary endpoint in a randomized late-stage trial, marking the first demonstration that such an approach can be…
    STAT · 20h agoPositive readoutPositive↗ source
  • Regeneron's Pasatru receives FDA approval for ultra-rare bone-growth disease FOP
    Regeneron Pharmaceuticals has secured FDA approval for Pasatru, a therapy aimed at treating fibrodysplasia ossificans progressiva (FOP), an ultra‑rare condition in which bone forms in soft tissues.…
    STAT · 20h agoApprovalPositive↗ source
  • Moderna shares surge as Merck-Moderna mRNA melanoma vaccine meets Phase 3 endpoint
    Merck and Moderna reported that their personalized mRNA cancer vaccine, combined with Merck’s Keytruda, slowed melanoma recurrence in a Phase 3 study. The interim analysis showed a statistically si…
    BioSpace · 23h agoPositive readoutPositive↗ source
  • Merck and Moderna report personalized mRNA vaccine delays melanoma recurrence in late-stage trial
    Merck and Moderna announced that a personalized mRNA cancer vaccine, when combined with standard therapy, slowed the return of melanoma and reduced its spread in a late-stage clinical study. The tr…
    STAT · 1d agoPositive readoutPositive↗ source
  • Moderna and Merck report success for personalized mRNA vaccine in late-stage melanoma trial
    Moderna and Merck announced that their personalized mRNA cancer vaccine succeeded in a late-stage melanoma study. The vaccine, called intismeran, was evaluated in a randomized Phase 3 trial, the fi…
    STAT · 1d agoPositive readoutPositive↗ source
  • FDA grants accelerated approval to Genglycos, first therapy for glycogen storage disease type Ia
    The U.S. Food and Drug Administration issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr), marking the first therapy for patients aged eight years and older with glycogen…
    fda press · 15h agoApprovalPositive↗ source
  • Heidi Overton nominated as FDA commissioner, seen as boost for psychedelics and non-opioid pain drugs
    President Donald Trump announced that he will nominate Heidi Overton, a current White House policy advisor, to serve as the next FDA commissioner pending Senate confirmation. Analysts say Overton’…
    BioSpace · 18h agoRegulatoryNeutral↗ source
  • FDA authorizes Aletta, first standalone robotic device for automated blood draws
    The U.S. Food and Drug Administration announced it has authorized Aletta, a robotic system that can draw blood without hands‑on operator involvement. The device is cleared for adult use in outpati…
    fda press · 20h agoRegulatoryPositive↗ source
  • Enveda’s oral obesity pill shows strong GI safety in Phase 1, paving way for trials in patients off GLP-1 drugs
    Enveda reported that its Phase 1 study of the oral obesity candidate ENV-308 demonstrated an exceptional gastrointestinal safety profile in healthy volunteers. The topline data, released on August…
    BioSpace · 1d agoPositive readoutPositive↗ source
  • Takeda’s FDA-approved Orzeyful expands treatment to all narcolepsy symptoms, challenging existing sleep drugs
    The U.S. Food and Drug Administration approved Takeda's drug Orzeyful in August, marking the first therapy that addresses the full spectrum of narcolepsy symptoms, including cataplexy and excessive…
    BioSpace · 1d agoApprovalPositive↗ source