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  • Vertex reports early kidney drug data, boosting hopes for broad label ahead of next year's pivotal readout
    Vertex Pharmaceuticals disclosed early data from its experimental kidney disease therapy inaxaplin, showing improvements on a urine-based biomarker. The drug demonstrated positive changes in two s…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Celldex's barzolvolimab meets Phase 3 goals but safety concerns emerge
    Celldex announced that its experimental chronic hives treatment, barzolvolimab, achieved the primary endpoint in two Phase 3 trials. The trials demonstrated the drug's efficacy in reducing hive sy…
    Endpoints · 1mo agoPositive readoutNeutral↗ source
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  • Nvidia-backed Iambic Therapeutics files for IPO, unveils AI-driven pipeline
    Iambic Therapeutics, a San Diego biotech that uses artificial intelligence to discover medicines, announced it has filed a registration statement to become a publicly traded company. The filing ma…
    Endpoints · 1mo agoDealNeutral↗ source
  • 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
  • Roche presents positive Phase 2 results for enicepatide in overweight and obese type 2 diabetes patients
    Roche has released new data from a Phase 2 trial of enicepatide, a peptide acquired from Carmot Therapeutics, focusing on overweight or obese adults with type 2 diabetes. The trial met its primary…
    Endpoints · 1mo agoPositive readoutPositive↗ 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
  • FDA issues third warning letter to Empower Pharmacy over GLP-1 weight-loss treatments
    The U.S. Food and Drug Administration sent a formal warning letter to Empower Pharmacy, a compounder based in Houston, concerning its GLP-1 weight-loss products. The notice marks the company's thi…
    Endpoints · 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
  • Federal AI Initiative Aims to Improve Chronic Heart Failure Care, Pending Doctor and Patient Acceptance
    A new federal program will test artificial‑intelligence tools in the management of chronic heart‑failure patients. The initiative is designed to explore how AI can support diagnosis, monitoring and…
    Endpoints · 1mo agoNeutral↗ source
  • Novo CEO acknowledges need to rebuild investor confidence after muted capital markets day
    Novo held a capital markets day on Monday in London, where the company outlined its strategy. Investors said the presentation left them underwhelmed. CEO Mike Doustdar acknowledged the reaction, s…
    Endpoints · 1mo agoNegative↗ source
  • Insurers Begin Accelerating AI Adoption After Lagging Behind Providers
    Insurers have traditionally been slower than health-care providers in adopting artificial intelligence tools, but the gap is narrowing. A growing share of insurers now say they plan to significant…
    Endpoints · 1mo agoPositive↗ 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
  • Viking touts once-a-month weight loss maintenance data
    Viking Therapeutics says patients who switched to a once-a-month dosing regimen of its obesity drug did not regain much weight after 12 weeks, bolstering the potential of a less frequent schedule.…
    Endpoints · 1mo agoNeutral↗ 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
  • 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
  • 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 presents low-dose CagriSema data showing competitiveness ahead of approval decision
    Novo used its capital markets day in London to unveil new low-dose data for its experimental metabolic therapy CagriSema. The data indicated that CagriSema performed comparably to Eli Lilly's Moun…
    Endpoints · 1mo agoPositive readoutPositive↗ 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
  • FDA issues rule to allow non-animal testing methods for drug safety
    FDA issued a direct final rule that updates its regulations to clarify that non-animal methods may be used for safety testing of drugs and biological products before they are tested in humans. The…
    fda press · 1mo agoRegulatoryPositive↗ 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
  • Beacon Therapeutics reports successful gene-therapy trial for rare X-linked retinitis pigmentosa
    Beacon Therapeutics announced that its gene-therapy candidate for X-linked retinitis pigmentosa (XLRP) achieved its primary endpoint in a pivotal trial. The result marks a breakthrough for the rar…
    Endpoints · 1mo agoPositive readoutPositive↗ source