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  • Only one third of US prostate cancer patients received pre-biopsy MRI in 2022, far below Western norms
    MRI is considered the standard pre-biopsy imaging tool for prostate cancer in most western nations, yet a new analysis shows that only about a third of US cases used it in 2022. In the United Stat…
    STAT · 1mo agoNegative↗ source
  • Excluding orphan drugs from Medicare pricing pilots could erase most savings, analysis shows
    A Harvard researcher has calculated that removing rare disease treatments from two Medicare pilot programs-GLOBE and GUARD-would dramatically cut the projected cost savings. The pilots are designe…
    STAT · 1mo agoRegulatoryNeutral↗ source
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  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Federal regulators hold closed-door meetings with tech firms to advance clinical AI adoption
    Federal health officials, including the FDA, CMS and HHS, convened a closed-door "clinical AI demo day" to discuss how to safely expand the use of artificial intelligence in clinical settings. The…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Early-stage trial shows fecal microbiome capsules improve peanut tolerance in some participants
    An early-phase clinical study examined whether oral capsules containing fecal microbiome material could help people with peanut allergy. Six volunteers received the treatment and were later exposed…
    STAT · 1mo agoPositive readoutPositive↗ source
  • Gilead reports modest sales rise but analysts question future growth beyond HIV drugs
    Gilead's second‑quarter results showed total product revenue of $7.6 billion, up 8% year‑over‑year. The company's two leading HIV treatments, Biktarvy and Descovy, together generated about $5.7 bi…
    BioPharma Dive · 1mo agoEarningsNeutral↗ source
  • Moderna begins early-stage trial of mRNA Ebola vaccine
    Moderna announced the launch of an early-phase clinical trial testing an mRNA vaccine designed to protect against Ebola virus. The study will enroll healthy volunteers to evaluate the vaccine's saf…
    STAT · 1mo agoNeutral↗ source
  • Medicaid policy shift could alter primary therapy for children with autism
    The article notes that the main therapy used for children with autism may be affected by upcoming Medicaid policy changes. It highlights that the therapy, which is a cornerstone of treatment for ma…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Senate probes alleged quid pro quo in Trump administration's easing of kratom and tobacco rules
    Senate Finance Committee's top Democrat has opened an inquiry into recent policy changes affecting flavored vaping products and kratom, alleging the Trump administration softened regulations in exc…
    STAT · 1mo agoRegulatoryNegative↗ source
  • STAT+: Federal regulators invite industry, researchers, and lobbyists to closed-door meetings on clinical AI
    Federal health officials invited tech companies and lobbyists to closed-door meetings as they seek to boost adoption of clinical AI.
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Call to unify MD and DO medical education pathways
    Physicians Abigail MacKenzie and Vijay Rajput argue that keeping medical education split between allopathic (MD) and osteopathic (DO) tracks is an outdated practice that adds no value to patient ca…
    STAT · 1mo agoPositive↗ source
  • Schrödinger CEO Ramy Farid rethinks role of AI in drug discovery
    In a recent STAT AI Prognosis newsletter, Schrödinger chief executive Ramy Farid discussed how his perspective on artificial intelligence is evolving. He reflected on recent conversations about AI…
    STAT · 1mo agoNeutral↗ source
  • Sun Noodle voluntarily recalls 134 packages of Sura Tanmen hot and sour noodles in Hawaii over undeclared fish allergen
    Sun Noodle of Honolulu announced a voluntary recall of its Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. The recall covers 134 packages, each 15.4 ounces, identified by lot…
    fda recalls · 1mo agoCRLNegative↗ source
  • Opinion: Films on assisted dying often ignore socioeconomic factors as New York law takes effect
    The piece, authored by Anna Magdalena Elsner and Vanessa Rampton, notes that New York's Medical Aid in Dying Act will become law on Aug 5, 2026, marking a major policy shift for terminally ill pati…
    STAT · 1mo agoNeutral↗ source
  • Vertex posts strong Q2 earnings, but upcoming Sionna cystic fibrosis data casts a shadow
    Vertex reported Q2 revenue from its cystic fibrosis portfolio exceeding $3.2 billion, beating estimates and prompting an upward revision of full‑year revenue guidance to $13.1‑$13.2 billion. Analy…
    BioPharma Dive · 1mo agoEarningsNeutral↗ source
  • Ebola outbreak in eastern Congo kills over 1,700 as cases surge past 3,800
    The latest government report shows that the Ebola outbreak in eastern Congo has resulted in more than 1,700 deaths and a total of 3,802 recorded cases. Health officials say that about 60-70% of ne…
    STAT · 1mo agoNegative↗ source
  • Gilead wins legal battle over HIV drug as Eli Lilly opens early access program for obesity therapy retatrutide
    Gilead Sciences secured a court victory concerning one of its HIV medicines, according to the brief report. The ruling resolves a legal dispute that had been pending, allowing the company to contin…
    STAT · 1mo agoRegulatoryPositive↗ source
  • J&J pharma chief Jennifer Taubert to retire; Krystal Biotech shares plunge after gene therapy revenue shortfall
    Johnson & Johnson announced that Jennifer Taubert will step down as head of its pharmaceutical division after a 21‑year tenure. During her time she oversaw commercial strategy, dealmaking and the…
    BioPharma Dive · 1mo agoNegative↗ source
  • UK regulator debates whether AI scribes count as medical devices
    UK regulators are examining whether AI-driven clinical documentation tools, often called AI scribes, should be classified as medical devices under current law. The proposal has generated debate am…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Analysis questions expanded orphan drug exemptions under recent legislation
    Ed Silverman, a Pharmalot columnist, examined a provision in the One Big Beautiful Bill Act that keeps certain orphan drugs out of Medicare price negotiations. The Inflation Reduction Act, which b…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Kennedy and Oz dismiss Medicaid cut claims, but state officials warn new rules could strip coverage
    Health secretary Robert F. Kennedy Jr. and former Vice President Dan Oz asserted that the administration is not cutting Medicaid, calling the idea a myth during a farm visit in Michigan. State Med…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Pfizer expands cost-cutting program, targeting $1 billion in new savings through 2029
    Pfizer announced it is expanding a cost-cutting initiative first launched in 2023 to further reduce expenses. The new measures are projected to generate about $1 billion in additional savings by 2…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Eli Lilly expands early-access program for experimental obesity drug retatrutide
    Eli Lilly announced it will broaden its early-access initiative for retatrutide, an investigational drug targeting obesity. The company said the program will let additional patients apply for the…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Aurora Therapeutics halts its custom CRISPR program and cuts staff after competitor Beam moves ahead
    Aurora Therapeutics, a startup developing personalized gene-editing drugs, announced it is abandoning its lead CRISPR program. The decision came just seven months after the company launched, and i…
    STAT · 1mo agoLayoffsNegative↗ source
  • Early Alert: Intraosseous Needle Set Issue from Becton Dickinson
    BD is recalling certain BD Intraosseous Vascular Access System Needle Sets due to difficulty removing the obturator (stylet) following placement.
    fda medwatch · 1mo agoRegulatoryNeutral↗ source