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394 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 · 5h 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 · 1h agoDealPositive↗ source
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Infectious Disease444
  • 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 · 4h agoPositive readoutPositive↗ source
  • Abbott receives FDA clearance for TactiFlex Duo catheter, offering flexible AFib ablation options
    Abbott announced that the U.S. Food and Drug Administration has cleared its new TactiFlex Duo catheter for use in atrial fibrillation ablation. The catheter can deliver pulsed field ablation, radi…
    Fierce Biotech · 9h agoRegulatoryPositive↗ 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 · 3h agoNeutral↗ 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 · just nowLayoffsNegative↗ 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
  • AstraZeneca’s IL-33 antibody tozorakimab earns FDA priority review after COPD trial cuts exacerbations by up to 34%
    AstraZeneca’s R&D chief medical officer Sharon Barr said the company’s latest data on its IL-33 inhibitor represents an internal “science success story.” The results have earned the drug a priority…
    Fierce Biotech · 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 · 1d 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 · 20h 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
  • Novartis shares tumble after late-stage failure of Avidity-acquired drug
    Novartis announced that its late-stage trial of a drug it acquired from Avidity did not meet its primary endpoints. The setback follows a recent disappointment in a heart disease study, adding pres…
    Endpoints · 1d agoNegative readoutNegative↗ source
  • Novartis' del-desiran fails primary endpoint in phase 3 Harbor trial for myotonic dystrophy type 1
    Novartis announced that its experimental therapy del-desiran did not meet the primary endpoint in the phase 3 Harbor trial, which evaluated improvement in video hand opening time in patients with m…
    Fierce Biotech · 1d agoNegative readoutNegative↗ 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 · 1d 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
  • 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 · 2d agoNegative readoutNegative↗ 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 · 2d agoNegative readoutNegative↗ 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