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  • 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
  • Siemens Healthineers partners with Novo to raise awareness and testing for fatty liver disease
    Siemens Healthineers and Novo have announced a collaboration aimed at increasing awareness and improving diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD) and its progre…
    Fierce Biotech · 1mo agoDealPositive↗ source
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  • 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
  • Cordis receives FDA approval for first sirolimus drug-coated balloon for coronary in-stent restenosis
    The U.S. Food and Drug Administration has approved a new device from Cordis that delivers sirolimus via a drug-coated balloon. This is the first sirolimus-eluting balloon cleared for use in treatin…
    Fierce Biotech · 1mo agoApprovalPositive↗ source
  • Iambic Therapeutics eyes IPO as it pushes HER2 inhibitor IAM1363 into early trials
    Iambic Therapeutics, a San Diego AI‑driven biotech, said it is preparing for an initial public offering after securing several large‑scale partnerships with major pharmaceutical companies. In its…
    Fierce Biotech · 1mo agoPositive↗ 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
  • Lexeo Therapeutics acquires Mantle Therapeutics for $8.3M to expand Friedreich ataxia pipeline
    Lexeo Therapeutics announced it will acquire Mantle Therapeutics for an upfront payment of $8.3 million, aiming to broaden its Friedreich ataxia pipeline. The transaction could rise to $21.3 milli…
    Fierce Biotech · 1mo agoDealPositive↗ 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
  • 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
  • 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
  • Anaconda Biomed snares $56M in funding for endovascular tech
    Medtech startup Anaconda Biomed has hauled in $53 million to help finish off work on a pivotal trial for its endovascular project.
    Fierce Biotech · 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
  • 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