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  • Sino Biopharm signs separate respiratory partnership deals with AstraZeneca and GSK
    Sino Biopharm announced it has entered into two distinct agreements with UK-based pharmaceutical companies focused on respiratory medicines. One agreement involves licensing its investigational PD…
    Endpoints · 1mo agoDealPositive↗ source
  • Satellos Bioscience presents early adult data for Duchenne muscular dystrophy pill ahead of child trial
    Satellos Bioscience, a Canadian biotech, has released early results from its Phase 2 study of an oral therapy for Duchenne muscular dystrophy in adult patients. The data are intended to strengthen…
    Endpoints · 1mo agoNeutral↗ source
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  • HHS pushes FDA to formalize public release of rejection letters to drug makers
    HHS announced it is preparing a new FDA regulation that would codify the agency's practice of publishing complete response letters (CRLs) that inform pharmaceutical companies of a drug's rejection.…
    Endpoints · 1mo agoCRLNeutral↗ source
  • ACA insurers seek median 14% premium hike for 2027 as enrollment falls
    Insurers filing with state regulators for 2027 ACA plans are asking for a median premium increase of 14%, according to an analysis of filings in 16 states and the District of Columbia. This would…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Biohaven targets muscle-sparing obesity market to compete with Lilly's GLP-1 drugs
    Biohaven is positioning itself to address obesity by developing treatments that preserve lean muscle, a differentiator from existing GLP-1 therapies. The company sees an opportunity to act as a "s…
    Endpoints · 1mo agoNeutral↗ source
  • FDA targets online ketamine sellers as health premiums surge, and children 2+ can now obtain CGMs without prescription
    The Food and Drug Administration is intensifying its enforcement against online retailers that sell ketamine, a controlled substance, citing concerns about unregulated distribution and public safet…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • AI licensure debate overlooks physician responsibility for patient outcomes
    The authors argue that discussions about licensing artificial intelligence tools in medicine miss the core purpose of licensure, which is accountability for clinical results. They illustrate a scen…
    STAT · 1mo agoNeutral↗ source
  • Trump administration seeks lasting overhaul of federal science policy after court setbacks
    The White House has introduced a proposal to cement its authority over federal research contracts, allowing the executive branch to direct research, end grants, and control external scientific revi…
    STAT · 1mo agoRegulatoryNegative↗ source
  • AI chatbots could provide companionship for people with dementia, but their role raises complex questions
    Jason Karlawish, a professor at the University of Pennsylvania, writes an opinion piece exploring how artificial-intelligence chatbots might be used in dementia care. He recounts the story of Doug…
    STAT · 1mo agoNeutral↗ source
  • Mass General Brigham nurses begin largest strike in Massachusetts over pay and benefits
    Thousands of nurses at Brigham and Women’s Hospital walked off the job on Wednesday, marking the first strike at the Harvard‑affiliated facility and the largest nurses walkout in the state’s histor…
    STAT · 1mo agoNegative↗ source
  • Sanofi proposes to cease negative statements about CSL's flu vaccine amid EU probe
    Sanofi has offered to stop making disparaging comments about CSL's flu vaccine following an investigation launched by the European Commission. The offer comes two weeks after the Commission began p…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • FDA clears first over-the-counter glucose monitor for children 2 and older
    The FDA cleared Dexcom's Stelo continuous glucose monitor for over-the-counter sale, allowing children age 2 and up to obtain the device without a prescription. The agency says real-time glucose d…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • RFK Jr. moves to compile list of Covid-19 vaccine injuries to streamline compensation claims
    Health secretary Robert F. Kennedy Jr. announced plans to create a list of injuries that would be presumed caused by Covid-19 vaccines. The list would allow individuals who suffer from those condi…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Longevity entrepreneur Bryan Johnson reveals he has autoimmune gastritis, a hard-to-diagnose stomach disease
    Bryan Johnson, known for his longevity ventures, announced on X that he has been diagnosed with autoimmune gastritis. The condition is a chronic inflammatory disease where antibodies attack stomac…
    STAT · 1mo agoNeutral↗ source
  • Vertex to acquire endocrinology startup Crinetics for $10 billion, signaling push into new therapeutic areas
    Vertex Pharmaceuticals announced a $10 billion cash purchase of Crinetics, an endocrinology-focused biotech. The deal represents the largest acquisition in Vertex’s history and underscores its pla…
    Endpoints · 1mo agoDealPositive↗ source
  • Tampa General kicks off legal fight over Lilly's 340B restrictions
    Tampa General Hospital sued Eli Lilly for halting its 340B discounts, kicking off a broader fight over whether pharmaceutical companies can condition drug discounts on new claims data requirements.…
    Endpoints · 1mo ago↗ source
  • Vera's IgAN approval kicks off competition with Otsuka
    Vera Therapeutics’ fusion protein atacicept got an accelerated approval on Tuesday for a chronic autoimmune disease that damages the kidneys. The drug will be marketed as Trutakna for immunoglobuli…
    Endpoints · 1mo ago↗ source
  • STAT+: FDA approves Vera Therapeutics kidney disease treatment
    The FDA approved a new medicine from the biotech company Vera Therapeutics for patients with a type of chronic autoimmune kidney disease.
    STAT · 1mo ago↗ source
  • Oberland pours up to $400M into MeiraGTx eye gene therapies
    The funding deal is a vote of confidence in the sales potential of multiple prospects in late-stage development — one of which MeiraGTx recently reacquired from J&J.
    BioPharma Dive · 1mo ago↗ source
  • Kailera says obesity pill succeeds in late-stage trial in China
    The drug spurred about 10% weight loss over 10 months, though that finding came alongside high rates of gastrointestinal side effects that “alarmed” one analyst.
    BioPharma Dive · 1mo ago↗ source
  • STAT+: The crumbling employer-based health insurance system
    Today's D.C. Diagnosis newsletter covers maintaining diversity in drug trials and troubling trends in employer-based health insurance.
    STAT · 1mo ago↗ source
  • Compass Pathways touts durability data for psilocybin drug in depression ahead of year-end filing
    Compass Pathways said Tuesday that patients in the second of its two pivotal psilocybin trials maintained their response to treatment for at least six months, keeping the company on track to comple…
    Endpoints · 1mo ago↗ source
  • Hengrui, Kailera's GLP-1 pill posts encouraging efficacy but high side effect rates in late-stage China trials
    The GLP-1 pill being developed by Hengrui Pharma and Kailera Therapeutics posted decent results in two late-stage China-based trials — one in obesity and the other in diabetes. But the safety profi…
    Endpoints · 1mo ago↗ source
  • STAT+: Compass says depression drug has long-lasting benefits
    Vertex makes its largest-ever deal, skyrocketing health insurance costs, and more biotech news from The Readout
    STAT · 1mo ago↗ source
  • STAT+: America’s employer health insurance is decaying
    STAT's Bob Herman examines the under-the-radar crisis brewing in employer-based health insurance.
    STAT · 1mo ago↗ source