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  • Iowa audit finds PBM kept over $100 million by inflating Medicaid drug costs
    A recent audit of Iowa's Medicaid program uncovered that a major pharmacy benefit manager used complex claim handling methods that led to higher costs for the state. The review of records from 201…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Kyverna Therapeutics aims to file first CAR-T cell therapy for autoimmune disease
    Kyverna Therapeutics is preparing what could become the first regulatory filing for a CAR-T cell therapy targeting an autoimmune condition. The company has been developing its miv-cel construct in…
    BioSpace · 1mo agoRegulatoryPositive↗ source
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  • Bristol Myers teams with Nvidia to launch large AI data center as Samsung Biologics bids $1.8 bn for Swiss peptide maker
    Bristol Myers Squibb announced expansion of its partnership with Nvidia, deploying two AI systems to create a powerful AI factory for life‑science research, aiming to tackle larger problems without…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • HHS vaccine committee receives new charter amid broader health policy updates
    The U.S. Health and Human Services vaccine advisory panel has been granted a new charter, a change that was noted quietly in a recent health newsletter. The same briefing highlighted other policy…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Pandemics Should Be Treated as National Security Threats, Experts Argue
    In an opinion piece, David Blumenthal and James A. Morone argue that pandemics should be classified and addressed as national security threats rather than solely health-care challenges. They note…
    STAT · 1mo agoPositive↗ source
  • FDA maintains focus on Taylor Farms lettuce as source of cyclospora outbreak despite false‑positive test
    Federal health officials said on Monday that the FDA continues to target shredded lettuce from Taylor Farms as the likely source of a multistate cyclospora outbreak, even after a laboratory result…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Physician blames U.S. health insurance failures after husband's suicide
    Joy Evers, an emergency physician, recounts the death of her husband Randy by suicide, describing how she expected her family’s high-quality commercial health insurance to ensure he received timely…
    STAT · 1mo agoNegative↗ source
  • Australia's TGA opens consultation to revamp rules for digital mental health tools
    The Therapeutic Goods Administration (TGA) has launched a public consultation aimed at updating the regulatory framework that governs digital mental health tools in Australia. The move seeks to cla…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Fugitive ex-doctor arrested after two decades posing as biotech executive
    Federal and Rhode Island authorities arrested Ronald Fischer, 70, after tracking a 56-foot sailboat off New Jersey. He had been on the run for about 20 years. Fischer, a former anesthesiologist, v…
    STAT · 1mo agoRegulatoryNegative↗ source
  • U.S. Military's New Testosterone Screening Raises Health Concerns
    The Department of Defense announced a mandatory testosterone screening program for all service members, prompting discussion among medical experts. A urologist who studies men’s health cautions th…
    STAT · 1mo agoNegative↗ source
  • STAT invites reader letters on primary care value, obesity as disease and broader health-care debates
    STAT’s First Opinion platform encourages readers to submit letters responding to its essays, fostering open, good‑faith discussion about health‑care topics. Recent letters, echoing comments from t…
    STAT · 1mo agoNeutral↗ source
  • Compounders still supply about 20% of US GLP-1 weight-loss market despite FDA crackdown and shortages
    A recent Gallup survey shows that while the number of Americans taking GLP-1 weight‑loss drugs has nearly quadrupled over the past two years, roughly one in five are using cheaper, non‑FDA‑approved…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • GSK drops camlipant cough drug after mixed Phase 3 results
    GSK announced it is halting development of camlipant, an experimental chronic cough medicine it acquired in a $2 billion purchase three years ago. The decision follows two Phase 3 trials that show…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Sonothera reports ultrasound method delivers high levels of dystrophin in monkeys, a potential new route for Duchenne therapy
    A California startup, Sonothera, is proposing an ultrasound‑based approach to deliver genes for Duchenne muscular dystrophy treatment. The company says its technology can introduce full-size dystr…
    STAT · 1mo agoPositive readoutNeutral↗ source
  • Medicare proposal would boost doctor pay for smoking and alcohol counseling by 19%
    A proposed change to Medicare’s physician fee schedule would increase reimbursement for doctors who provide counseling on tobacco cessation and alcohol or substance misuse. The proposal adds a 19%…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Jasper Therapeutics secures $132 million and merges with Kira Pharmaceuticals to revive pipeline
    Jasper Therapeutics, a cash‑strapped biotech, announced it completed an all‑stock acquisition of privately held immune‑drug developer Kira Pharmaceuticals. The merger is paired with a private stoc…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • India’s life-sciences sector faces scaling hurdles despite rapid innovation growth, report says
    India’s life‑sciences sector has shown rapid growth, according to a new report by Boston Consulting Group and HealthKois. Patent filings have risen more than four‑fold since 2016, the pipeline of i…
    BioSpace · 1mo agoNeutral↗ source
  • Arbutus and Sanofi launch new patent lawsuits against Pfizer, BioNTech and Moderna over mRNA lipid nanoparticle technology
    Arbutus BioPharma filed three new lawsuits against Pfizer and BioNTech, accusing them of infringing patents covering the lipid nanoparticle (LNP) technology used to deliver mRNA vaccines. The filin…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • U.S. drug shortages climb to 227 active cases in Q2 2026
    The United States reported a rise in active medication shortages during the second quarter of 2026, with the total reaching 227. The increase signals growing pressure on the pharmaceutical supply…
    STAT · 1mo agoNeutral↗ source
  • AI-discovered drugs show early promise but face mixed results in clinical trials
    AI is being promoted as a way to cut the cost and time of drug research and development, which can exceed $2.6 billion and take up to 15 years. Only a handful of AI‑identified compounds have enter…
    BioPharma Dive · 1mo agoNeutral↗ source
  • GSK drops chronic cough drug camlipixant after mixed Phase 3 results
    GSK announced it will stop investing in camlipixant for refractory chronic cough after the drug failed to meet key endpoints in a late-stage trial. The company had run two Phase 3 studies, CALM-1…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Insmed's inhaled PAH therapy shows durable efficacy in 12-month extension, bolstering $6B sales outlook
    Insmed reported that its inhalable prostanoid candidate, treprostinil palmitil inhalation powder (TPIP), maintained functional and biomarker benefits through a 12‑month open‑label extension in pati…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • FDA says former officials' journal articles do not represent agency policy after lawmaker criticism
    Acting FDA director Kyle Diamantas wrote to House Energy & Commerce ranking member Diana DeGette, stating that journal papers authored by former agency officials do not convey FDA policy or regulat…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • MDCalc introduces quality-rating system for over 800 clinical calculators used by doctors
    MDCalc, a health‑technology company, announced a new quality‑rating system that will evaluate the more than 800 clinical calculators doctors rely on for decisions such as kidney function, birth out…
    STAT · 1mo agoPositive↗ source
  • FDA proposal to drop adequate provision could effectively ban prescription drug ads
    FDA staff are proposing to eliminate the adequate provision requirement in direct-to-consumer prescription-drug advertisements. The adequate provision currently obliges advertisers to present a bal…
    raps · 1mo agoRegulatoryNegative↗ source