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327 stories matching this filter · ← front page

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  • Novo Nordisk halts two IL-6 heart trials as Novartis suffers Phase 3 setbacks; Ionis wins first Alexander disease approval
    Novo Nordisk announced it has ended two late‑stage studies of its investigational IL‑6 inhibitor ziltivekimab, which was being evaluated for cardiovascular disease. The decision follows an earlier…
    BioSpace · 20h agoNegative↗ source
  • ARPA-H commits $62.7 million to develop FDA-authorized AI for heart-failure treatment
    ARPA-H announced a $62.7 million investment to create artificial-intelligence systems that can assist in treating heart failure. The program, called ADVOCATE, seeks to develop partially autonomous…
    STAT · 16h agoDealPositive↗ source
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  • AstraZeneca's COPD drug cuts flare-ups in late-stage trials, offering new option for patients
    In two late-stage studies, an AstraZeneca therapy showed a statistically significant reduction in acute exacerbations that worsen chronic obstructive pulmonary disease. The data, released on Tuesda…
    STAT · 19h agoPositive readoutPositive↗ source
  • UK commission proposes new framework to regulate AI-driven medical tools
    A UK commission released a report on Thursday outlining 44 recommendations for how artificial intelligence should be governed in the medical sector. The guidance aims to capture AI's promise, such…
    STAT · 9h agoRegulatoryNeutral↗ source
  • Webinar explores how GLP-1 obesity drugs are reshaping US healthcare and market dynamics
    The upcoming webinar titled "The Massive Scale of GLP-1s: Evolving Health, Healthcare and Markets" will examine how GLP-1 receptor agonists used for obesity are altering the U.S. health-care landsc…
    BioSpace · 18h agoNeutral↗ source
  • Two infants die in Pennsylvania measles outbreak, coroner confirms one death caused by virus
    Pennsylvania’s health coroner released details about two infant deaths that occurred during a growing measles outbreak in the state. The first infant, Ivan Miller, died on Aug. 14 shortly after bi…
    STAT · 10h agoNegative↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 9h agoLayoffsNegative↗ source
  • Novartis' $12 billion Avidity drug fails Phase 3 trial in myotonic dystrophy
    Novartis reported that its antibody-oligonucleotide conjugate del-desiran did not meet the primary endpoint in the Phase 3 HARBOR study for myotonic dystrophy type 1, showing no significant improve…
    BioSpace · 1d agoNegative readoutNegative↗ source
  • AstraZeneca’s experimental COPD drug tozorakimab cuts flare-ups by 30% in Phase 3 trials
    In two Phase 3 studies, AstraZeneca’s injectable COPD candidate tozorakimab reduced the rate of disease exacerbations by roughly 30%, according to data released on Tuesday. The trials measured flar…
    STAT · 1d agoPositive readoutPositive↗ source
  • FDA approves AstraZeneca's new breast cancer therapy
    The U.S. Food and Drug Administration has granted approval for AstraZeneca's latest breast cancer drug, expanding treatment options for patients with the disease. The approval follows a review of…
    STAT · 1d agoApprovalPositive↗ source
  • Roivant's experimental pulmonary hypertension drug meets Phase 2 goals
    Roivant announced that its experimental drug mosliciguat achieved the primary endpoint in a 16‑week Phase 2 trial for pulmonary hypertension, a serious lung condition. The study showed a 56% reduc…
    STAT · 1d agoPositive readoutPositive↗ source
  • Novartis' DM1 drug del-desiran misses primary endpoint in Phase 3 HARBOR trial
    Novartis announced that its experimental therapy del-desiran did not improve muscle function in a pivotal Phase 3 study for myotonic dystrophy type 1 (DM1). The trial, called HARBOR, evaluated the…
    STAT · 2d agoNegative readoutNegative↗ source
  • Novo Nordisk halts two more late-stage heart failure trials, calling IL-6 an invalid target
    Novo Nordisk said it is ending two late-stage heart-failure studies, HERMES and ATHENA, that were testing its IL-6 inhibitor ziltivekimab. The company cited a recommendation from the Data Monitorin…
    BioSpace · 1d agoNegative readoutNegative↗ source
  • Novartis' experimental drug fails pivotal trial for rare neuromuscular disease
    Novartis reported that its experimental therapy for a rare neuromuscular disorder did not improve muscle function in a pivotal study, missing its primary endpoints. The failure represents the comp…
    STAT · 1d agoNegative readoutNegative↗ source
  • FDA makes permanent four key leadership appointments, including first AI deputy commissioner
    The Food and Drug Administration announced that three officials who have been serving in acting capacities will now be confirmed as permanent heads of its major centers. Michael Davis, a psychiatr…
    STAT · 1d agoRegulatoryPositive↗ source
  • Novartis' pelacarsen fails Phase 3, casting doubt on Lp(a) lowering strategy
    Novartis announced that its antisense drug pelacarsen failed to meet the primary endpoint in the Phase 3 Lp(a)HORIZON trial. The study was intended to determine whether the drug’s ability to lower…
    BioSpace · 1d agoNegative readoutNegative↗ source
  • Inhibrx reports promising responses to OX40 immunotherapy in HPV-positive head and neck cancer
    Inhibrx announced that its experimental immunotherapy targeting the protein OX40 produced measurable responses in patients with head and neck cancer, with the clearest activity observed in a small…
    STAT · 1d agoPositive readoutPositive↗ source
  • FDA approves AstraZeneca breast cancer drug despite negative advisory committee vote; Novartis faces cholesterol drug setbacks
    The U.S. Food and Drug Administration granted approval to AstraZeneca's breast cancer therapy even though the advisory committee voted against it. The decision underscores the agency's willingness…
    raps · 2d agoRegulatoryNeutral↗ source
  • Administrative gap stalls access to new pancreatic cancer therapy
    A recent Morning Rounds report notes that patients awaiting a new pancreatic cancer treatment are encountering delays because an administrative gap has halted its rollout. The story explains that…
    STAT · 1d agoRegulatoryNegative↗ source
  • 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 · 1d agoDealPositive↗ 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 · 2d agoNegative readoutNegative↗ 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 · 3d agoNegative↗ 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 · 5d agoNegative readoutNegative↗ source
  • Disabled workers face higher risk of losing health insurance, report highlights systemic gaps
    The Morning Rounds newsletter reports that disabled employees are more likely to lose their health coverage, underscoring a systemic vulnerability in the U.S. health insurance landscape. The artic…
    STAT · 5d agoNegative↗ source
  • Gene-edited pig kidneys enable patients to go months without dialysis before receiving human transplants
    Doctors at eGenesis reported that two patients who received genetically engineered pig kidneys were later able to receive human donor kidneys after a period on dialysis. The transition was not seam…
    STAT · 6d agoPositive↗ source