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  • Former FDA Commissioners Endorse Heidi Overton as Strong Choice to Lead Agency
    Two former FDA commissioners, Scott Gottlieb and Mark B. McClellan, wrote an opinion piece supporting Heidi Overton’s nomination to lead the agency. They note her confirmation hearing is set before…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Compass Therapeutics to file BLA for tovecimig despite FDA call for new trial
    Compass Therapeutics announced it will continue pursuing a biologics license application (BLA) for its bispecific antibody tovecimig aimed at advanced biliary tract cancer, even after the FDA sugge…
    BioSpace · 1mo agoRegulatoryNegative↗ source
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  • Novo Nordisk may secure more favorable terms under Medicare’s Bridge obesity drug program
    Novo Nordisk and Eli Lilly have been profiting from a Medicare pilot that caps obesity drug prices for seniors at $245 a month. Recent analysis suggests Novo could negotiate an even better arrangem…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Novo Nordisk cuts 13,000 jobs to redirect funds toward R&D
    Novo Nordisk announced further workforce reductions, bringing total departures to about 13,000 over the past year. CEO Maziar Mike Doustdar said the cuts are intended to free up capital for resear…
    BioSpace · 1mo agoLayoffsNegative↗ source
  • Boehringer Ingelheim to invest up to $1B in AI-driven solid tumor partnership with Envisagenics
    Boehringer Ingelheim announced a partnership with Envisagenics to develop precision oncology therapies that use artificial intelligence to identify cancer-specific RNA splicing alterations. The co…
    BioSpace · 1mo agoDealPositive↗ source
  • GOP health policy guru continues to support $1 trillion Medicaid cuts, warning of next target
    Brian Blase, president of the Paragon Health Institute, has become a trusted adviser to Republican lawmakers and has publicly defended sweeping Medicaid reductions. The One Big Beautiful Bill Act,…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Trump Medicaid pricing plan may give Novo Nordisk unexpected financial boost
    STAT reports that the White House introduced a plan aimed at lowering the cost of drugs for Medicaid beneficiaries. The policy includes provisions that reduce prices of obesity treatments for senio…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Western pharma firms lobby Trump administration to preserve China partnership opportunities
    Western pharmaceutical companies are urging the Trump administration to permit continued collaborations with Chinese firms on promising drug candidates, despite a 2025 law that limits U.S. investme…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Lilly presents early data supporting GLP-1/GIP candidate's potential in depression, alcohol use disorder
    With a trillion-dollar market cap and a wildly successful GLP-1 portfolio, Eli Lilly isn’t resting on its laurels. At the Psych Congress 2026, the company presented early-stage data that could supp…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Regulators Share Guidance for Effective Sponsor Meetings
    Regulators from the U.S. FDA, the U.K. MHRA and other European agencies met to outline best practices for sponsor‑regulator interactions. They highlighted that transparency, open collaboration, at…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Global regulators must align on new approach methodologies to give sponsors certainty
    New approach methodologies, or NAMs, are being promoted as ways to reduce reliance on animal testing in drug development. They promise faster, more humane studies while still providing safety data.…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Pharma firms ask Trump admin to safeguard China partnerships as EU pushes for quicker trials and higher spending
    Pharma companies in the United States are urging the Trump administration to take steps that would protect their existing and future business arrangements with Chinese partners. At the same time,…
    raps · 1mo agoRegulatoryNeutral↗ source
  • STAT Health Tech newsletter highlights Epic's AI mortality model and Omada's upcoming products
    The latest STAT Health Tech newsletter edition spotlights two developments in health technology. It reviews Epic Systems' new mortality prediction algorithm, an artificial intelligence tool design…
    STAT · 1mo agoNeutral↗ source
  • Integrative Oncology Proven to Ease Cancer Symptoms, Yet Insurance Still Refuses Coverage
    Professor Lorenzo Cohen, a distinguished integrative oncology researcher and melanoma survivor, argues that the science supporting symptom-relieving therapies for cancer patients is well establishe…
    STAT · 1mo agoNegative↗ source
  • Ohio governor race pits former public health director against biotech entrepreneur, highlighting Covid response and health policy
    The Ohio gubernatorial contest features Democratic nominee Dr. Amy Acton, the former state public health director who gained national attention for Ohio’s aggressive Covid-19 response in 2020. She…
    STAT · 1mo agoNeutral↗ source
  • John Gaitanis appointed chair of federal autism committee amid disclosed leucovorin ties
    The Interagency Autism Coordinating Committee (IACC) has named pediatric neurologist John Gaitanis as its new chair. Gaitanis, who has spent his career treating children with neurological disorder…
    STAT · 1mo agoNegative↗ source
  • Global social media bans for teens spark call for rigorous impact research
    Australia became the first country in December 2025 to prohibit social media use for anyone under 16, and Indonesia quickly followed with a similar restriction. The European Union has taken a sligh…
    STAT · 1mo agoNeutral↗ source
  • Vertex opens up larger kidney disease opportunity with mid-stage readout
    While Vertex is laser-focused on an upcoming FDA decision for povetacicept in immunoglobulin A nephropathy, the APOL1 inhibitor inaxaplin has demonstrated potential “best-in-class” data in a differ…
    BioSpace · 1mo ago↗ source
  • Grail’s Galleri blood test sees 33% stock jump as FDA hints at favorable advisory panel outlook
    Shares of Grail rose sharply on Monday after the FDA released documents ahead of an advisory committee meeting, suggesting a positive view of the company’s multi‑cancer blood test, Galleri. The up…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Telix to acquire ITM Isotope Technologies for $1.65 billion, adding late-stage radiopharma asset ITM-11
    Telix Pharmaceuticals announced it will purchase Germany‑based ITM Isotope Technologies Munich for $1.65 billion in cash. The agreement also provides for up to $700 million in milestone payments l…
    BioSpace · 1mo agoDealPositive↗ source
  • FDA approves Lilly's new combination therapy for advanced breast cancer
    The U.S. Food and Drug Administration has granted approval for a new combination drug regimen developed by Eli Lilly for patients with an advanced form of breast cancer. The therapy pairs two agen…
    STAT · 1mo agoApprovalPositive↗ source
  • Novo Nordisk vows to launch five multi-blockbuster drugs by 2030 as it shifts toward consumer-style products
    Novo Nordisk used its London capital markets day to reassure investors that the company will broaden its pipeline and market new medicines more like consumer products than traditional drugs. The C…
    STAT · 1mo agoNeutral↗ source
  • New KRAS-targeting drug daraxonrasib approved for pancreatic cancer as experts call for $100 billion NIH budget
    The FDA has approved daraxonrasib, a therapy from Revolution Medicines that targets the KRAS mutation in pancreatic cancer. The drug is intended for patients who have already received treatment and…
    STAT · 1mo agoApprovalPositive↗ source
  • Experts see Replimune’s Tudriqev approval as a step toward broader use of localized cancer therapies
    Replimune received FDA approval last month for Tudriqev, an oncolytic virus injected directly into melanoma tumors, marking only the second such approval for a therapy delivered straight into a tum…
    BioSpace · 1mo agoApprovalPositive↗ source
  • Transposase-based cell line platform speeds development and raises protein yields for complex biologics
    Advanced cell line development tools are helping biopharma tackle the expression and stability challenges of increasingly complex molecules such as bispecifics and trispecifics. The article highli…
    BioSpace · 1mo agoPositive↗ source