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  • U.S. government launches first federally funded ibogaine trials for opioid addiction and PTSD
    The Trump administration announced the start of the United States' first government‑funded clinical trials of ibogaine, a psychedelic compound being investigated for its potential to treat opioid u…
    STAT · 15d agoRegulatoryPositive↗ source
  • Compliance worries keep AI adoption in drug manufacturing low, survey finds
    A new survey of more than 400 research and manufacturing professionals shows that over 90% of drugmakers have not committed to expanding AI use in regulated drug production. While AI is widely em…
    BioSpace · 15d agoRegulatoryNegative↗ source
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  • Experts warn FDA against approving Grail’s ineffective multicancer blood test
    Physician and cancer‑screening researcher H. Gilbert Welch argues that the FDA should not greenlight Grail’s multicancer blood test, noting the company’s trial of 140,000 participants used a weak s…
    STAT · 15d agoRegulatoryNegative↗ source
  • BioSpace honors 40 emerging leaders shaping biopharma with breakthroughs in mRNA, gene and cell therapies
    BioSpace announced its latest 40 Under 40 cohort, recognizing young professionals who have made notable contributions across biopharma. The honorees span a range of roles, from scientific innovator…
    BioSpace · 15d agoPositive↗ source
  • Doctor warns AI-driven documentation may boost hospital bills without improving care
    A resident physician writes that recent Blue Cross Blue Shield research has sparked anger by suggesting hospitals use AI tools to increase charges without adding care. The study claims hospitals e…
    STAT · 15d agoNegative↗ source
  • Hospitals Launch Cash‑Pay Longevity Clinics, Offering Intensive Health Monitoring
    Prestigious hospitals across the United States have begun offering cash‑pay longevity programs that promise comprehensive health monitoring for patients willing to spend thousands of dollars out of…
    STAT · 15d agoNeutral↗ source
  • FDA outlines roadmap for AI guidance to be released in 2027
    The Food and Drug Administration announced a roadmap for new artificial intelligence guidance that it plans to publish in 2027. The upcoming guidances are expected to establish a framework for dev…
    STAT · 15d agoRegulatoryNeutral↗ source
  • Trump proposes $90 monthly aid for seniors as stem cell therapies gain attention
    STAT's D.C. Diagnosis newsletter notes that stem cell treatments are being discussed as a possible next breakthrough in medicine, likening them to the rise of peptide therapies. President Trump an…
    STAT · 15d agoNeutral↗ source
  • Nonprofit hospitals launch pricey longevity clinics offering personalized health assessments
    Longevity clinics, which promise individualized health advice and advanced testing, are now being opened by major nonprofit hospitals. The services aim to map the health trajectories of patients ac…
    STAT · 15d agoNegative↗ source
  • Study finds pulse oximeters at Johns Hopkins shifted from overestimating to underestimating oxygen, with larger errors in patients of color
    A retrospective analysis of five years of pulse‑oximeter data from Johns Hopkins Hospital shows a shift in measurement bias. Earlier research documented that the devices tend to overestimate oxyge…
    STAT · 15d agoNeutral↗ source
  • Infectious disease expert urges calm over mysterious pneumonia case in Siberia
    A 28‑year‑old laboratory worker at a Siberian institute that studies plague died after developing severe pneumonia, prompting a quarantine of a nearby hospital and monitoring of roughly 200 contact…
    STAT · 14d agoNeutral↗ source
  • When to get your flu shot: key factors to consider
    The article addresses the question of the optimal timing for a flu vaccination. It notes that deciding when to receive the shot can depend on several practical considerations. Readers are encourag…
    STAT · 15d agoNeutral↗ source
  • Shionogi makes $2B rare disease play with IntraBio buy
    With its acquisition of IntraBio, Shionogi will gain ownership over Aqneursa, which could hit peak global sales of $1 billion across its two indications in Niemann-Pick disease type C and ataxia-te…
    BioSpace · 15d ago↗ source
  • FDA extends review of Novo’s hemophilia A drug, citing manufacturing issues
    Despite the regulatory delay, Novo is still expecting a 2027 launch for its hemophilia A drug denecimig.
    BioSpace · 15d ago↗ source
  • Eli Lilly's Jaypirca receives FDA approval for first-line treatment of untreated CLL and SLL
    Eli Lilly announced that the FDA has approved its drug Jaypirca as a first‑line therapy for patients with previously untreated chronic lymphocytic leukemia and small lymphocytic lymphoma. The appr…
    STAT · 16d agoApprovalPositive↗ source
  • Vaxcyte’s VAX-31 shows superior results in Phase 3, beating Pfizer and Merck’s pneumococcal vaccines and sparking $8 bn market hopes
    Vaxcyte reported that its investigational pneumococcal conjugate vaccine, VAX-31, met the co-primary endpoints in a Phase 3 trial, demonstrating non-inferiority to the existing shots from Pfizer an…
    BioSpace · 16d agoPositive readoutPositive↗ source
  • Late-stage mRNA melanoma vaccine shows promise, slowing disease recurrence
    A late-stage trial of an mRNA-based cancer vaccine reported that the treatment halted the return of melanoma in patients, providing the first clear evidence of efficacy for this approach. Merck an…
    STAT · 16d agoPositive readoutPositive↗ source
  • Genentech signs up to develop Alector’s preclinical blood-brain barrier therapy in $1.27 billion deal
    Genentech, a Roche subsidiary, announced a deal with Alector to obtain exclusive rights to its preclinical blood-brain barrier delivery asset, AL050. The agreement provides $100 million upfront an…
    BioSpace · 16d agoDealPositive↗ source
  • FDA urged to boost US access to new and experimental drugs as trials shift to China
    The piece highlights that the FDA has taken steps such as launching Operation TrialBlazer and tightening review of foreign clinical data, but argues that further action is required to keep the Unit…
    BioSpace · 16d agoRegulatoryNegative↗ source
  • Lilly adds $870M to Gate Bioscience partnership to pursue new drug targets
    Eli Lilly is expanding its collaboration with Gate Bioscience, adding a new financial commitment of more than $870 million. The original July 2025 agreement gave Lilly access to Gate’s "Molecular…
    BioSpace · 16d agoDealPositive↗ source
  • Nobel-winning optogenetics opens path to experimental therapies for blindness and Alzheimer’s
    Optogenetics, a technique that uses light to control neurons, earned a 2026 Nobel Prize. Researchers say the method is transforming brain mapping from a simple roadmap to a detailed, three-dimensi…
    STAT · 16d agoPositive↗ source
  • Trump administration issues new rules to standardize health-insurance pricing disclosures
    The Trump administration on Monday issued new regulations that require health-insurance companies to release cleaned-up spreadsheets showing the amounts they pay hospitals and physicians. The rules…
    STAT · 16d agoRegulatoryNeutral↗ source
  • Viking Therapeutics jumps 24% after Phase 1 obesity data, Longeveron falls 64% on mid-stage setback
    In September biotech stocks showed wide swings, with Viking Therapeutics gaining 24% and Longeveron dropping 64% as investors reacted to clinical data and trial setbacks. Viking reported Phase 1 r…
    BioSpace · 16d agoPositive readoutNeutral↗ source
  • Utah moves forward with AI-driven acne prescription pilot, Nolla Health to test autonomous drug prescribing
    Utah regulators announced a plan to allow an artificial intelligence product to evaluate patients and generate drug prescriptions without prior human review. Nolla Health, a startup, will launch a…
    STAT · 16d agoRegulatoryNeutral↗ source
  • Biogen's litifilimab shows clear or almost clear skin in cutaneous lupus after one year
    Biogen reported that its experimental antibody litifilimab produced clear or almost clear skin in patients with cutaneous lupus erythematosus after one year of treatment in a mid‑stage study. The r…
    BioSpace · 16d agoPositive readoutPositive↗ source