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  • AHRQ cuts $109 million in health services research grants, ending 78 projects early
    AHRQ announced that dozens of health services research grants will stop early, affecting about $109 million still to be spent. The agency said it is reshaping its discretionary award portfolio to…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Nabla executive Alex LeBrun discusses ‘world model’ AI as an alternative to large language models
    Brittany Trang of STAT’s AI Prognosis newsletter interviewed Alex LeBrun, the executive chairman of AI scribe company Nabla, to explore a concept called a “world model.” LeBrun described a world m…
    STAT · 3mo agoNeutral↗ source
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  • Argentina’s World Cup defeat offers a cautionary lesson for U.S. hospitals on avoiding complacency
    Opinion writer Basel Tarab, a physician and hospital administrator, reflects on Argentina’s recent World Cup loss as a metaphor for American health‑care systems. He recalls Argentina’s 2022 triump…
    STAT · 3mo agoNeutral↗ source
  • MDCG: Only manufacturers should assign UDI-DIs
    The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better…
    raps · 3mo agoNeutral↗ source
  • FDA revokes Orange B color additive and proposes to drop Citrus Red No. 2 from food approvals
    The U.S. Food and Drug Administration issued a final order that revokes the authorized use of Orange B as a food color additive. The agency also proposed revoking Citrus Red No. 2, a pigment autho…
    fda press · 3mo agoRegulatoryNeutral↗ source
  • Broad Institute, Boston Children’s Hospital and Jackson Laboratory launch nonprofit to advance affordable gene therapies for rare diseases
    The Broad Institute, Boston Children’s Hospital and Maine’s Jackson Laboratory announced a new collaboration to develop gene‑based treatments for rare genetic disorders. The three institutions will…
    STAT · 3mo agoDealPositive↗ source
  • Anthropic expands rare disease collaborations as Novo sues Lilly and Agios halts sickle cell drug
    Anthropic, a biotech firm, announced it is expanding its partnership portfolio focused on rare disease therapeutics, deepening collaborations with several companies to advance pipeline candidates.…
    STAT · 3mo agoDealNeutral↗ source
  • Novo Nordisk sues Eli Lilly over allegedly deceptive obesity and diabetes ads
    Novo Nordisk has filed a federal lawsuit against Eli Lilly, accusing the rival of running misleading advertisements for its obesity and diabetes medicines. The company claims Lilly's ads rely on ou…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Novo Nordisk sues Eli Lilly, alleging deceptive ads that misrepresent GLP-1 drug efficacy
    Novo Nordisk filed a lawsuit in federal court in New Jersey accusing Eli Lilly of running a deceptive advertising campaign. The complaint says Lilly’s ads compare the highest doses of its weight‑l…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Rare-disease biotech coalition urges Trump admin to carve out orphan drugs from Medicare price-cut pilots
    Biotech firms formed the Rare Disease Company Coalition and met with the White House Office of Management and Budget to discuss excluding orphan drugs from two Medicare price‑cut pilot programs. T…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • FDA issues warning letters for CGMP breaches and inadequate trial consent, EU releases AI transparency guidelines
    The U.S. Food and Drug Administration sent warning letters to several drug manufacturers for not meeting current good manufacturing practice requirements. One firm was also cited for failing to pr…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Rare disease drugmakers brace for potential Trump administration price cuts amid GOP push on health‑care fraud
    Rare disease drugmakers are watching the Trump administration closely as proposals emerge that could force lower prices for their specialty therapies. The companies are exploring strategies to miti…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Advocates warn federal HIV prevention funding cuts could force community groups to close
    Community-based organizations that deliver HIV testing and prevention tools are urging federal health officials to restore a key funding program that recently expired. Advocates say the lapse thre…
    STAT · 3mo agoRegulatoryNegative↗ source
  • THC-infused drinks found on New York shelves near schools, often sold without ID and breaching state law
    A variety of cannabis-infused beverages are now stocked in grocery stores, bodegas and delis across New York City. Brands such as Oasis, Cann, Milonga, Cycling Frog, Tempters, Gigli and Mighty Kind…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Proposed OMB Rule Threatens NIH Grant Independence, Experts Warn
    The Office of Management and Budget has issued a proposed rule that would require political appointees to review NIH research grants and certify that the projects "demonstrably advance the Presiden…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Trump administration defers over $1 billion in Medicaid payments to California and Minnesota over fraud concerns
    The Trump administration announced it is holding back more than $1 billion in Medicaid funds for California and Minnesota, saying the states have suspected fraud and non‑compliance. Health Secreta…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Urologist warns that Defense Dept's testosterone screening for servicemembers fuels outdated masculinity myths
    Dr. Elizabeth Dray, a urologist, criticizes Defense Secretary Pete Hegseth's recent plan to screen all service members aged 30 and older for testosterone, describing it as a modern echo of ancient…
    STAT · 3mo agoNegative↗ source
  • Epic Systems sees senior leadership exits amid speculation of broader exodus
    Epic Systems is experiencing notable executive turnover, highlighted by the recent departure of President Sumit Rana, who had been expected to succeed CEO Judy Faulkner. Rana told a reporter last…
    STAT · 3mo agoNegative↗ source
  • Nabla appoints former Bamboo Health president Brian Manning as CEO to boost US market push
    Nabla, the Paris‑based maker of ambient AI scribes for clinical documentation, announced that Brian Manning will take over as chief executive officer. Manning comes from a background in care‑coord…
    STAT · 3mo agoNeutral↗ source
  • EU releases AI Act transparency guidelines, impacting healthcare AI developers
    The European Commission published new guidelines on Monday to help providers and deployers of AI systems meet the transparency obligations set out in the EU AI Act. The guidance includes examples…
    raps · 3mo agoRegulatoryNeutral↗ source
  • EU releases AI Act transparency guidelines, affecting health-tech developers
    The European Commission has published new guidelines to help providers and users of artificial intelligence systems meet the transparency obligations set out in the EU AI Act. The document explain…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Right-wing groups intensify campaign to limit abortion pills amid ongoing health news
    Advocates on the political right are renewing efforts to restrict access to medication abortions, according to the latest Morning Rounds newsletter. The piece notes that the campaign is gaining mom…
    STAT · 3mo agoNegative↗ source
  • Opinion warns post-pandemic polarization may lock in false lessons from Covid response
    The authors, Marc Lipsitch and Sara Cody, argue that the public and policymakers are drawing misleading conclusions from the Covid-19 pandemic. They point out that early nonpharmaceutical interven…
    STAT · 3mo agoNegative↗ source
  • Medicare proposes cuts to hospital payments for drugs and imaging under new outpatient rule
    Medicare's Centers for Medicare & Medicaid Services released a proposed rule that would lower the amounts hospitals receive for certain prescription drugs and imaging services provided to Medicare…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Baxter alerts users to potential air bubble risk in Duo-Vent IV solution sets
    The FDA’s Center for Devices and Radiological Health has issued an early alert about a possible high-risk issue with Baxter’s Duo-Vent intravenous solution sets. The devices may contain air bubbles…
    fda medwatch · 3mo agoRegulatoryNegative↗ source