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2,491 stories matching this filter · ← front page

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  • AbbVie and BMS each secure FDA approval, but impact of their neuro‑drug acquisitions remains uncertain
    AbbVie and Bristol Myers Squibb have both received FDA clearance for new Parkinson's treatments, prompting a fresh look at the large neuro‑focused deals they completed last year. AbbVie bought Cere…
    BioSpace · 10h agoDealNeutral↗ source
  • FDA launches Rare Disease Framework to embed patient input early in drug development
    FDA's Center for Biologics Research and Evaluation (CBER) director Karim Mikhail announced a new Rare Disease Framework Initiative aimed at moving patient perspectives from an optional, late‑stage…
    BioSpace · 11h agoRegulatoryPositive↗ source
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  • Compass Pathways to file FDA approval for psilocybin depression therapy within weeks
    Compass Pathways announced it will complete its FDA filing for the psilocybin‑based depression treatment COMP360 in the next two weeks. The company expects the rolling submission to enable a drug…
    BioSpace · 14m agoRegulatoryNeutral↗ source
  • Eli Lilly to pursue FDA approval for obesity drug in obstructive sleep apnea after positive Phase 3 trial
    Eli Lilly announced that it will seek regulatory approval for its obesity medication as a treatment for obstructive sleep apnea, following a successful Phase 3 study. The trial showed positive res…
    Endpoints · 1h agoPositive readoutPositive↗ source
  • Novo’s IL-6 inhibitor ziltivekimab may target milder cardio-renal patients after Phase 3 miss
    At the American Heart Association meeting, investigators discussed new data on Novo Nordisk’s IL-6 inhibitor ziltivekimab, suggesting it could be studied in patients with less severe cardiovascular…
    BioSpace · 1h agoNegative readoutNeutral↗ source
  • Marea Therapeutics' triglyceride drug lowers levels without raising blood sugar in high-risk patients
    Marea Therapeutics reported new data on its investigational lipid‑lowering medicine, showing it can further reduce triglyceride levels in patients with dangerously high blood concentrations. The s…
    Endpoints · 2h agoPositive readoutPositive↗ source
  • Argenx to acquire macrocycle biotech Unnatural Products in up to $1.15 billion deal
    Argenx announced Monday it will acquire Unnatural Products, a biotech focused on macrocycle therapeutics that began as a garage startup. The transaction is structured as an up-to-$1.15 billion dea…
    Endpoints · 4h agoDealNeutral↗ source
  • Zura Bio’s Phase 2 trial of tibulizumab fails, shares plunge
    Zura Bio announced that its experimental drug tibulizumab did not meet efficacy endpoints in a Phase 2 study of a painful skin disorder. The company said that both dose levels performed no better t…
    Endpoints · 2h agoNegative readoutNegative↗ source
  • Gene therapy sponsors urged to address six GMP manufacturing considerations early
    SK pharmteco’s chief technical officer Tatiana Nanda explained that gene therapy sponsors need to think about manufacturing issues well before reaching GMP production. She told BioSpace that early…
    BioSpace · 11h 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 · 1h agoLayoffsNegative↗ source
  • #AHA26: Boehringer to seek approval of obesity shot, but gaining market share could be tricky
    Boehringer Ingelheim will seek approval for its incretin shot survodutide for obesity next year, after a trial showed that the drug doesn’t increase patients’ risk of cardiovascular events like hea…
    Endpoints · 7m ago↗ source
  • J&J and Protagonist’s Icotyde improves psoriatic arthritis but AbbVie’s Skyrizi likely to reign
    A Phase 3 trial showed that Johnson & Johnson and Protagonist Therapeutics’ oral therapy Icotyde improved psoriatic arthritis symptoms but AbbVie’s injectable is likely to hold court based on highe…
    BioSpace · 19m ago↗ source
  • Details from Novartis’ failed cardiovascular trial offer ‘little silver lining’ for rivals
    Full data from the Phase 3 HORIZON trial of Novartis' pelacarsen failed to show any apparent benefit, leading analysts to further reduce the odds of success for Lp(a)-lowering competitors such as A…
    BioSpace · 30m ago↗ source
  • Argenx buyout of peptide engine and Big Pharma favorite UNP could top $1B
    Unnatural Products has risen from founder Joshua Schwochert’s garage to an acquisition deal, valued at up to $1.15 billion, to join argenx.
    BioSpace · 41m ago↗ source
  • Update: FDA investigates Novartis' Zolgensma following 9 cases of tumors in treated patients
    After Novartis confirmed the reports of tumors in patients who have been treated with the spinal muscular atrophy gene therapy, the FDA will determine if any regulatory action is needed for Zolgens…
    BioSpace · 1h ago↗ source
  • Vir Biotechnology reports positive results for hepatitis D combo in first pivotal trial
    Vir Biotechnology announced that its chronic hepatitis D treatment met its primary goal in the first of three late‑stage studies. The trial evaluated a once‑monthly combination therapy that include…
    Endpoints · 18h agoPositive readoutPositive↗ source
  • Fresh & Ready Foods recalls 2,414 Fresh To You sausage, egg & cheese biscuit sandwiches over possible Listeria contamination
    Fresh & Ready Foods LLC of Renton, Washington announced a recall of 2,414 Fresh To You sausage, egg and cheese biscuit sandwiches after testing indicated a potential contamination with Listeria mon…
    fda recalls · 1d agoNegative↗ source
  • FDA opens investigation into Novartis' Zolgensma after cancer cases reported
    The U.S. Food and Drug Administration announced on Friday that it is opening a formal investigation into the gene-therapy product Zolgensma, marketed by Novartis for spinal muscular atrophy. The a…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • Novo and Novartis see heart drug setbacks as trials show minimal efficacy
    Novo's cardiovascular candidate failed to demonstrate meaningful benefit in its pivotal study, causing the company's shares to fall about 9% in July. The trial data showed the drug had little effe…
    Endpoints · 2d agoNegative readoutNegative↗ source
  • Democrats Take House, Raising Questions for Biopharma Policy
    Democrats secured control of Congress in a wave election held on Tuesday, shifting the political balance in Washington. The change is expected to influence the regulatory landscape for the biophar…
    Endpoints · 2d agoRegulatoryNeutral↗ source
  • Harvard scientist George Church quits AI startup Radical, alleging partner stole his credit
    George Church, a prominent Harvard researcher known for advising biotech and synthetic biology ventures, has stepped down from his role at the artificial‑intelligence startup Radical. In a public…
    Endpoints · 2d agoNegative↗ source
  • FDA grants accelerated approval to J&J's Rybrevant for recurrent head and neck cancer
    The U.S. Food and Drug Administration has issued an accelerated approval for Johnson & Johnson's antibody-drug conjugate Rybrevant targeting head and neck cancers that have returned after prior che…
    Endpoints · 2d agoApprovalPositive↗ source
  • Merck and Moderna report 99% manufacturing success and 42% lower recurrence risk for personalized melanoma vaccine in Phase 3 trial
    Merck and Moderna announced that their personalized mRNA cancer vaccine, combined with Keytruda, was successfully manufactured for 99% of patients enrolled in a large Phase 3 study. The trial, call…
    BioSpace · 3d agoPositive readoutPositive↗ source
  • Moderna reports 29% revenue rise as COVID vaccine sales stay steady amid global uptake
    Moderna said its quarterly revenue jumped 29% to $1.3 billion, driven by continued demand for its COVID-19 shots. The company has generated $1.8 billion in revenue so far this year, according to CF…
    BioSpace · 2d agoEarningsPositive↗ source
  • Amgen's Repatha shows reduced heart attack risk while Satellos alters Duchenne trial endpoint
    Satellos Bioscience announced a change to the primary endpoint of its ongoing Duchenne muscular dystrophy trial of the investigational small‑molecule forazapadin, shifting focus to a measure of mus…
    Endpoints · 2d agoPositive readoutPositive↗ source