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  • Epic faces antitrust lawsuits and internal AI strategy turmoil ahead of annual user meeting
    Epic Systems, founded by Judy Faulkner, dominates the U.S. hospital electronic health record market and convenes its annual User Group Meeting with more than 20,000 attendees. The upcoming gatheri…
    STAT · 1h agoRegulatoryNegative↗ source
  • North Carolina’s bipartisan Medicaid pilot shows social services can cut health costs
    The article, written by former state health secretaries Mandy Cohen and Kody Kinsley, says North Carolina’s health‑care affordability crisis was tackled through a bipartisan pilot. The Healthy Opp…
    STAT · 1h agoPositive↗ source
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  • State Laws Cut Private-Equity Acquisitions of Physician Practice Management Firms in Half
    State regulators in more than a dozen states have enacted laws that tighten oversight of private‑equity deals in health care, according to a new report. The tighter rules are reported to be slowing…
    STAT · 6h agoRegulatoryNeutral↗ source
  • Paid paternity leave framed as preventive pediatric care in new opinion piece
    Pediatrician Nishant Pandya shares a recent clinic scene where a new father had to return to work the day after his daughter’s birth, highlighting the tension many families face. He notes that whi…
    STAT · 1h agoPositive↗ source
  • STAT+: UnitedHealth faces IRS probe over potential tax avoidance
    The health insurer may face a significant increase in taxes, amid a dispute with federal authorities.
    STAT · 1h ago↗ source
  • STAT+: Kennedy’s split-screen week: Talk of vaccines in D.C., fraud and addiction out West
    The California trip shows how Kennedy likes to focus on key MAHA themes, while avoiding some divisive topics.
    STAT · 1h ago↗ source
  • FDA approves Bristol Myers' first oral therapy for advanced multiple myeloma, a new drug class
    The U.S. Food and Drug Administration gave its nod to an oral medication from Bristol Myers Squibb for patients with advanced multiple myeloma. The drug represents the first member of a novel clas…
    STAT · 2d agoApprovalPositive↗ source
  • FDA clears Bristol Myers' Zenbexus, first drug of a new class for advanced multiple myeloma
    The FDA announced approval of an oral therapy from Bristol Myers Squibb for patients with advanced multiple myeloma. The drug, iberdomide, will be marketed as Zenbexus and is intended to be used t…
    STAT · 2d agoApprovalPositive↗ source
  • Capricor shares jump as FDA signals openness to review updated Duchenne therapy
    Capricor Therapeutics saw its stock rise sharply after CEO Linda Marbán told analysts that the FDA is willing to look at an amended filing for its Duchenne muscular dystrophy cell therapy, deramioc…
    BioPharma Dive · 2d agoRegulatoryPositive↗ source
  • FDA grants accelerated approval to Bristol's Zenbexus for multiple myeloma; PBMs adopt TrumpRx pricing; Novartis wins UK Entresto patent
    The U.S. Food and Drug Administration granted accelerated approval to Bristol Myers Squibb's oral therapy Zenbexus for patients with advanced multiple myeloma. The drug represents a new class of tr…
    STAT · 2d agoApprovalPositive↗ source
  • FDA grants accelerated approval to Bristol Myers' Zenbexus, first CELMoD for multiple myeloma
    The FDA issued an accelerated approval on Thursday for Zenbexus, a multiple myeloma therapy that Bristol Myers Squibb inherited from its Celgene acquisition. Zenbexus belongs to a new class of pro…
    BioPharma Dive · 2d agoApprovalPositive↗ source
  • Drug-testing lab sues US Pharmacopeia over alleged false statements about testing methods
    Valisure, a laboratory known for testing drug impurities, has filed a lawsuit in a U.S. court accusing the United States Pharmacopeia (USP) of making false and misleading statements about its testi…
    STAT · 2d agoRegulatoryNegative↗ source
  • New state and federal funding fuels biotech hub growth in Pennsylvania, Kansas City and beyond
    Government programs in Pennsylvania, New York, Kansas City and Central Virginia are pouring new funding into regional biotech hubs as pharma manufacturing investment surges. Matt Gardner, sector p…
    BioPharma Dive · 2d agoPositive↗ source
  • Industry groups urge FDA to add clarity and flexibility to manufacturer-payor communication guidance
    Industry associations and other stakeholders have asked the U.S. Food and Drug Administration to give more detail and flexibility in its updated guidance on how drug and device makers talk with pay…
    raps · 3d agoRegulatoryNeutral↗ source
  • FTC launches antitrust probe into Epic Systems over alleged anticompetitive practices
    Federal Trade Commission investigators have reached out to at least three people as part of a broad inquiry into Epic Systems' business practices. Epic, the nation's largest electronic health reco…
    STAT · 2d agoRegulatoryNegative↗ source
  • Methadone clinics show mixed progress two years after regulatory overhaul
    In 2024 the federal government revised rules for opioid addiction treatment centers, giving them more leeway to provide take‑home methadone doses and removing the requirement that patients attend c…
    STAT · 3d agoRegulatoryNeutral↗ source
  • UnitedHealthcare CEO Brian Thompson killed; suspect Luigi Mangione pleads guilty to federal stalking
    Luigi Mangione, 28, pleaded guilty in Manhattan federal court to stalking charges tied to the 2024 killing of UnitedHealthcare chief executive Brian Thompson. He told the court he followed Thompso…
    STAT · 2d agoNegative↗ source
  • FDA issues final guidance on formal meeting types and timelines for drug and biologics sponsors
    The U.S. Food and Drug Administration released final guidance on August 13 that details the types of formal meetings sponsors can request during the development of new drugs and biologics. The doc…
    raps · 3d agoRegulatoryNeutral↗ source
  • US and UK health systems both prioritize clinical care over community prevention, author warns
    Kyle Vanelli argues that the United States and United Kingdom health systems share a fundamental flaw: they default to biomedical, hospital-based interventions rather than community-based preventiv…
    STAT · 3d agoNegative↗ source
  • CMS rule blocks Medicaid funding for pediatric gender-affirming care, raising legal challenges
    The Centers for Medicare and Medicaid Services finalized a rule that prohibits the use of Medicaid and CHIP dollars to cover pediatric gender‑affirming medications and surgeries. Previous attempts…
    STAT · 3d agoRegulatoryNeutral↗ source
  • Pediatricians push back against vaccine fear-mongering by federal leaders
    Andrew D. Racine, president of the American Academy of Pediatrics, writes an opinion piece warning that federal leaders are spreading misleading claims about vaccines, creating confusion for parent…
    STAT · 2d agoNegative↗ source
  • FDA releases weekly update on user fee letters and new HHS regulatory agenda
    The FDA's latest weekly briefing highlighted the release of user fee commitment letters, which outline the agency's financial planning for upcoming fiscal periods. It also introduced a new regulat…
    raps · 3d agoRegulatoryNeutral↗ source
  • Formation Bio appoints Michael Ehlers as chief scientific officer and head of R&D
    Formation Bio announced the hiring of Michael Ehlers as its new chief scientific officer and head of research and development. Ehlers brings experience from founding and leading Ascidian Therapeut…
    STAT · 2d agoPositive↗ source
  • Opinion: Car telematics warns of health-insurance data surveillance
    Sociologists Andréa Becker and Paul Kamuf argue that the telematics model used in auto insurance could become a template for health‑insurance data collection. They describe how drivers’ minute‑by‑…
    STAT · 3d agoNegative↗ source
  • Taiho and Cullinan report positive Phase 3 results for zipalertinib in EGFR exon 20 insertion lung cancer
    Taiho Oncology and Cullinan Therapeutics announced that their experimental drug zipalertinib achieved positive results in a Phase 3 trial for first‑line treatment of lung cancer patients whose tumo…
    BioPharma Dive · 3d agoPositive readoutPositive↗ source