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  • Epic’s dominance forces health-care AI firms to adapt, new STAT+ analysis finds
    The latest STAT+ AI Prognosis newsletter examines how Epic’s entrenched position in electronic health-record systems is shaping the strategies of health-care artificial-intelligence companies. The…
    STAT · 13d agoNeutral↗ source
  • FDA issues draft guidance for electronic IDE submissions via eSTAR
    The U.S. Food and Drug Administration released draft guidance outlining how sponsors can submit investigational device exemption (IDE) applications using the electronic Submission Template and Reso…
    raps · 13d agoRegulatoryNeutral↗ source
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  • HHS pauses enforcement of ban on compounding wellness peptides as FDA drafts new rules
    HHS announced it will temporarily stop enforcing the existing prohibition on the compounding of certain peptides marketed for wellness. The agency said the move is intended to protect consumer saf…
    Endpoints · 13d agoRegulatoryNeutral↗ source
  • U.S. overdose deaths fell 27% in 2024, with early 2025 data showing further decline
    U.S. overdose mortality dropped 27% in 2024 after years of steep increases, and preliminary figures for 2025 suggest the trend is continuing, though the overall death rate remains high. A Health a…
    STAT · 13d agoPositive↗ source
  • Pediatricians work to calm families and promote MMR vaccination amid Pennsylvania measles outbreak
    A pediatrician at the Children’s Hospital of Philadelphia describes a growing measles outbreak in Pennsylvania, noting more than 1,300 reported cases with roughly a third affecting children. Paren…
    STAT · 13d agoNeutral↗ source
  • Michigan Senate candidate Abdul El-Sayed vows to challenge RFK Jr. and push Medicare for All
    Abdul El‑Sayed, a Michigan Democrat and former public‑health official, is nearing the end of a contentious Senate campaign. He has announced he will aggressively question Robert F. Kennedy Jr., lab…
    STAT · 13d agoNeutral↗ source
  • Physician's personal egg-freezing story highlights systemic sexism in fertility industry
    In an opinion piece, NYU assistant professor Pooja Yerramilli reflects on her own egg-freezing experience after Democratic Representative Alexandria Ocasio-Cortez sparked a national conversation ab…
    STAT · 13d agoNegative↗ source
  • STAT seeks input on how Epic's practices affect hospital technology choices
    Epic is the largest electronic health records vendor in the United States, with its systems used by most large health systems and covering the health data of roughly eight in ten Americans. Indust…
    STAT · 13d agoNeutral↗ source
  • STAT+: Lilly’s triple-G drug beats Ozempic in head-to-head study
    Eli Lilly announced that its investigational drug retatrutide was more effective at lowering blood sugar and cutting weight than Novo Nordisk’s Ozempic in a large diabetes study.
    STAT · 13d ago↗ source
  • Lilly's triple-G drug retatrutide outshines Novo's Ozempic in diabetes
    Eli Lilly’s retatrutide, the incretin shot that has already proven its effectiveness against other assets on a cross-trial basis, has cemented its utility in a head-to-head trial, albeit in diabete…
    Endpoints · 13d ago↗ source
  • Phase 3 trial shows cancer vaccine intismeran autogene cuts recurrence risk by 42% versus Keytruda
    At the European Society for Medical Oncology Congress, a Phase 3 trial of the personalized cancer vaccine intismeran autogene reported a 42% reduction in risk of recurrence or death compared with p…
    STAT · 14d agoPositive readoutPositive↗ source
  • Novartis reaffirms $12 billion Avidity acquisition despite $1.9 billion impairment loss
    Novartis said its $12 billion purchase of Avidity Biosciences remains on track, according to CEO Vas Narasimhan. The comment followed the company's disclosure of a $1.9 billion impairment charge t…
    Endpoints · 14d agoDealNeutral↗ source
  • Novartis CEO keeps faith in Avidity deal despite taking $1.9B hit from del-desiran fail
    Novartis CEO Vas Narasimhan has insisted that the phase 3 fail for del-desiran is just a “bump” in the Swiss pharma’s wider plans for the drug, despite costing the company an estimated $1.9 billion.
    Fierce Biotech · 14d agoNegative readoutNegative↗ source
  • GSK's B7-H3 ADC cuts osteosarcoma progression risk by 67% in Chinese phase 3 trial
    A phase 3 study in China evaluated GSK's B7-H3‑directed antibody‑drug conjugate, risvutatug rezetecan (ris‑rez), in patients with relapsed osteosarcoma. The trial met its primary endpoint, showing…
    Fierce Biotech · 14d agoPositive readoutPositive↗ source
  • US Treasury draft COINS rules could sharply limit China biotech partnerships
    US Treasury released a draft set of regulations known as the COINS rule that targets cross-border biotech transactions. The proposal would bar certain US-China deals and tighten oversight of collab…
    Endpoints · 13d agoRegulatoryNegative↗ source
  • Syntax Bio claims four-day stem-cell conversion into pancreatic beta cells
    Chicago-based Syntax Bio says its Cellgorithm platform can turn stem cells into pancreatic beta cells in as little as four days. The company describes the process as a programmable set of epigeneti…
    Fierce Biotech · 14d agoPositive readoutPositive↗ source
  • Ferring agrees to buy fertility startup Gameto in deal up to $1.38 billion
    Ferring Pharmaceuticals announced it has signed an agreement to acquire Gameto, a biotech company developing an ovary-in-a-dish platform for fertility treatments. The transaction is structured as…
    Endpoints · 14d agoDealNeutral↗ source
  • Novartis weighs private-pay launches in Europe as MFN rules pressure government pricing
    Novartis CEO Vas Narasimhan said the company is exploring the option of introducing new medicines directly to private or self‑pay patients in Europe. The discussion is driven by the European Union…
    Endpoints · 14d agoRegulatoryNegative↗ source
  • Artiva Biotherapeutics cuts 94% of workforce after patient deaths and failed autoimmune cell therapy
    Artiva Biotherapeutics announced it is halting development of its AlloNK natural killer cell therapy for autoimmune diseases and is laying off roughly 94% of its employees. The AlloNK product, an…
    Fierce Biotech · 14d agoLayoffsNegative↗ source
  • Labcorp acquires Millennium Health to expand toxicology testing nationwide
    Labcorp announced it is buying Millennium Health, a specialty laboratory that provides toxicology tests for recent use of prescription medications and illicit drugs. The acquisition is intended to…
    Fierce Biotech · 14d agoDealPositive↗ source
  • FDA releases draft guidance on oversight of individualized gene-editing products
    The U.S. Food and Drug Administration issued draft guidance that outlines a proposed regulatory framework for individualized gene‑editing products, including cases where multiple product variants a…
    raps · 14d agoRegulatoryNeutral↗ source
  • FDA releases details on accelerated approval process for personalized gene therapies
    The U.S. Food and Drug Administration has issued additional guidance on a faster approval pathway designed for personalized gene therapies. The new details outline how sponsors can seek expedited r…
    STAT · 14d agoRegulatoryPositive↗ source
  • Artiva Biotherapeutics to cease operations after two deaths in autoimmune cell therapy trials
    Artiva Biotherapeutics announced it will wind down and lay off nearly all staff following two patient fatalities in its autoimmune cell therapy trials. The deaths occurred during clinical testing…
    Endpoints · 14d agoNegative↗ source
  • Biopharma optimism climbs after FDA commissioner Makary's exit, survey finds
    Endpoints Signal released its Q3 Biopharma Sentiment Index, showing the highest level of industry optimism in years, according to a survey of 569 insiders. The index’s regulatory score rose sharpl…
    Endpoints · 14d agoRegulatoryPositive↗ source
  • U.S. judge denies effort to block Eli Lilly's weight-loss ad; GSK reports oncology drug approval
    A U.S. district judge rejected a request to halt Eli Lilly's advertising campaign that Novo Nordisk alleges is deceptive in promoting its weight‑loss medicines. Novo Nordisk argued the ads could m…
    STAT · 14d agoRegulatoryNeutral↗ source