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  • FDA makes CBER and CDER leaders permanent amid pending commissioner confirmation
    The FDA announced that the heads of its two major centers, CBER and CDER, have been given permanent appointments. The move provides stability for the centers that oversee biologics and drugs, resp…
    Endpoints · 2mo agoRegulatoryNeutral↗ source
  • Tech giants and health apps push users to link medical records for personalized services
    In the past six months, a wave of tech giants and digital‑health startups have begun urging users to connect their personal medical records through their mobile applications. These companies argue…
    Endpoints · 2mo agoNeutral↗ source
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  • Oura files for IPO after reporting $1.2 billion in earnings
    Oura, the maker of popular health tracking rings, announced it will go public through an initial public offering. The company disclosed that it generated $1.2 billion in earnings during its most r…
    STAT · 2mo agoDealPositive↗ source
  • UnitedHealth executives donate over $100,000 to Rep. Katherine Clark ahead of midterms
    UnitedHealth Group’s chief executive Stephen Hemsley and other senior leaders gave campaign contributions to Rep. Katherine Clark, a top Democrat in the House. The contributions total more than $1…
    STAT · 2mo agoNeutral↗ source
  • Four CDMOs to watch as biopharma outsourcing grows
    The article lists four contract development and manufacturing organizations (CDMOs) that biopharma companies can partner with as demand for external development and manufacturing rises. Lonza, bas…
    BioSpace · 2mo agoNeutral↗ source
  • Experts say gloves are unnecessary for flu shots, urging a shift to reduce waste
    Cassandra Thiel, an assistant professor of population health, and Preeti Jaggi, a pediatrics professor, note that they regularly see vaccination technicians sanitize their hands, put on nitrile glo…
    STAT · 2mo agoPositive↗ source
  • Consumer apps are turning to patient health records to expand services
    A few years ago patients had to remember every provider they visited and log into each portal separately to collect their full medical history. Gathering records was a fragmented and time‑consuming…
    Endpoints · 2mo agoNeutral↗ source
  • Medical student speaks out against weight bias in clinical training
    A fourth‑year medical student at Tufts University School of Medicine describes being called out for wearing plus‑size scrubs and feeling singled out in the operating room. She recounts a nurse’s c…
    STAT · 2mo agoPositive↗ source
  • Novartis reports Phase 3 pelacarsen trial fails to improve cardiovascular outcomes
    Novartis said its late-stage Phase 3 trial of the antisense drug pelacarsen did not show a benefit in reducing major cardiovascular events compared with placebo. The result adds to a recent string…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • FDA grants accelerated approval to AstraZeneca's oral SERD for breast cancer despite advisory panel opposition
    FDA granted accelerated approval to AstraZeneca's oral selective estrogen receptor degrader, Camizestrant, for a specific group of breast cancer patients. The approval was issued on Friday even th…
    Endpoints · 2mo agoApprovalPositive↗ source
  • Novo Nordisk abandons two phase 3 trials of ziltivekimab, dimming blockbuster hopes
    Novo Nordisk announced it is terminating two late‑stage phase 3 studies of its IL‑6 ligand antibody ziltivekimab. The Hermes and Athena trials enrolled about 4,900 and 673 patients with heart fail…
    Fierce Biotech · 2mo agoNegative readoutNegative↗ source
  • Boston Scientific warns cyberattack will likely hit Q3 and full-year 2026 results
    Boston Scientific disclosed in a September 7 SEC filing that a cyberattack it suffered last month is expected to have a material impact on its third‑quarter and full‑year 2026 financial results. T…
    Fierce Biotech · 2mo agoNegative↗ source
  • Guardant Health receives FDA clearance for Guardant360 CDx to guide AstraZeneca's Etcamah in breast cancer
    Guardant Health announced that the FDA has cleared its Guardant360 CDx test, which is designed to identify patients who may benefit from AstraZeneca's newly approved breast cancer therapy Etcamah.…
    Fierce Biotech · 2mo agoApprovalPositive↗ source
  • Novo Nordisk halts two cardiovascular trials of inflammation-targeting drug ziltivekimab
    Novo Nordisk announced it is halting the HERMES and ATHENA cardiovascular trials of its experimental drug ziltivekimab, which was intended to lower inflammation to improve heart health. A data mon…
    STAT · 2mo agoNegative readoutNegative↗ source
  • Novo Nordisk halts two late-stage ziltivekimab heart trials after futility finding
    Novo Nordisk announced it has stopped work early on two additional late-stage clinical studies of its IL-6 inhibitor ziltivekimab, which was being evaluated for heart disease. The decision followe…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • Claret Capital Partners raises €575 million Fund IV to boost European biotech lending
    Claret Capital Partners, a European investment firm, announced that its fourth fund has closed at €575 million. The firm said a significant share of the capital will be deployed as loans to life-s…
    Endpoints · 2mo agoDealNeutral↗ source
  • BrainChild Bio masterminds $116M series A for CAR-T's pivotal push in pediatric brain cancer
    A startup spawned from Seattle Children’s Hospital has raised a $116 million series A to advance cell therapies for devastating childhood brain tumors.
    Fierce Biotech · 2mo agoNeutral↗ source
  • ADARx, backed by AbbVie, files for IPO to fund clinical-stage siRNA programs
    ADARx Pharmaceuticals, a San Diego biotech supported by AbbVie, announced plans to pursue an initial public offering. The company says most of the IPO proceeds will be used to advance three clinic…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Roivant’s inhaled pulmonary hypertension drug mosliciguat shows strong Phase 2 results
    Roivant invested $14 million in Bayer's inhaled soluble guanylate cyclase activator mosliciguat after a $294 million biobucks agreement in 2024, and promptly advanced the candidate into a Phase 2 s…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • ADA panel still reviewing expulsions from June conference, further actions possible
    The American Diabetes Association released top‑line findings on Sept. 1 from an internal panel tasked with reviewing the June 5 expulsion of five members at its New Orleans conference. The full re…
    STAT · 2mo agoNegative↗ source
  • Novartis pauses CAR-T trials after three patient deaths
    Novartis announced a pause on its experimental CAR-T therapy after three patients died while receiving the treatment. The company said it will halt ongoing immunology and neuroscience studies relat…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • ADARx Pharmaceuticals, backed by AbbVie, files for IPO with three RNAi drugs in clinical trials
    ADARx Pharmaceuticals, an RNA interference biotech based in San Diego, disclosed its plan to go public in a Friday night SEC filing. The company aims to capitalize on the current momentum in biotec…
    Endpoints · 2mo agoDealNeutral↗ source
  • STAT readers weigh in on MD vs DO training, AI accountability and surrogacy in medicine
    STAT’s First Opinion platform invites letters that respond to its essays, and a recent submission addresses several hot topics in health care. The writer acknowledges the bias that osteopathic gra…
    STAT · 2mo agoNeutral↗ source
  • Novartis' experimental heart drug pelacarsen fails pivotal Phase 3 trial
    Novartis announced that its experimental cardiovascular therapy, pelacarsen, did not meet its primary endpoints in the Phase 3 HORIZON trial. The study compared the drug to placebo and found no red…
    STAT · 2mo agoNegative readoutNegative↗ source
  • FDA grants accelerated approval for Etcamah combo therapy for advanced HR-positive, HER2-negative breast cancer
    The U.S. Food and Drug Administration announced accelerated approval of Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for adult patients with hormone-receptor-positive, HER2-negativ…
    fda press · 2mo agoApprovalPositive↗ source