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3,104 stories matching this filter · ← front page

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  • Argenx to acquire peptide specialist Unnatural Products in deal worth up to $1.15 billion
    Argenx announced it will purchase Unnatural Products, a peptide discovery biotech, in a transaction that could total up to $1.15 billion. The deal provides $550 million upfront, with additional co…
    BioSpace · 1h agoDealPositive↗ source
  • FDA warns GLP-1 weight-loss drugs may cause rare eye stroke condition
    The Food and Drug Administration issued a warning that GLP-1 drugs used for weight loss may be linked to a rare eye condition called non-arteritic anterior ischemic optic neuropathy, sometimes desc…
    STAT · 1h agoRegulatoryNegative↗ source
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  • Novartis' Phase 3 HORIZON trial shows pelacarsen lowers Lp(a) but fails to cut cardiovascular events
    Novartis and Ionis reported that the Phase 3 HORIZON trial of the antisense drug pelacarsen did not improve major adverse cardiovascular events despite markedly lowering lipoprotein(a) levels. The…
    BioSpace · 1h agoNegative readoutNegative↗ source
  • New evidence links gene‑therapy viral vectors to tumor formation in pediatric patients
    For years, scientists have debated whether the viral vectors used in gene therapy could cause cancer. Recent case reports now provide strong evidence that such a risk is real. The reports involve…
    STAT · 2h agoNegative readoutNegative↗ source
  • 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 · 12h 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 · 12h agoRegulatoryPositive↗ source
  • 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 · 1h agoRegulatoryNeutral↗ source
  • J&J/Protagonist’s oral Icotyde shows Phase 3 benefit in psoriatic arthritis but trails AbbVie’s Skyrizi
    A Phase 3 study of Johnson & Johnson and Protagonist Therapeutics’ oral IL‑23 receptor antagonist Icotyde met its primary endpoint, demonstrating improvement in psoriatic arthritis symptoms. In th…
    BioSpace · 1h agoPositive readoutNeutral↗ source
  • Lilly's oral GLP-1 pill Foundayo reduces sleep apnea events in late-stage trials
    In two late-stage trials, Eli Lilly’s oral GLP‑1 pill Foundayo lowered the apnea‑hypopnea index by an average of 17.8 events per hour, compared with a 4.5‑event reduction for patients on placebo.…
    STAT · 2h 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 · 3h agoNegative readoutNeutral↗ source
  • Democrats weigh limits of health-care reforms after midterm win
    In the days after their sweeping midterm victories, House and Senate Democrats are debating the scope of possible health-care actions. Party leaders agree on rolling back the Medicaid cuts impleme…
    STAT · 7h agoRegulatoryNeutral↗ source
  • Global liver experts agree on definition of acute-on-chronic liver failure
    Liver doctors from many countries have reached a common definition for acute-on-chronic liver failure, a serious complication that occurs when an existing liver disease is suddenly worsened by an a…
    STAT · 7h agoPositive↗ source
  • CVS split into two entities fails to address core issues in pharmacy benefit management
    CVS Health is one of the largest U.S. companies, serving hundreds of millions of Americans and generating about $400 billion in annual revenue. It touches nearly every step of the drug supply chain…
    STAT · 7h agoNegative↗ 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 · 12h agoNeutral↗ source
  • Trump administration issues new guidelines to curb AI-driven bioweapon threats
    The White House announced a set of guidelines aimed at preventing the misuse of artificial intelligence in creating biological weapons. Officials said the rapid advances in AI-driven drug discovery…
    STAT · 4h agoRegulatoryNeutral↗ source
  • AI chatbots may help men share emotions, study suggests
    AI chatbots are not therapists, but they can offer a low‑pressure space where men feel less judged when discussing personal concerns. The article follows Luca, who drove across Europe to be with h…
    STAT · 7h 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 · 2h agoLayoffsNegative↗ source
  • STAT+: Heart association meeting’s readout is trending ‘neutral’
    The theme of the American Heart Association meetings was "neutral" results. Yet no one wants to stop pursuing inflammation or Lp(a) lowering.
    STAT · 18m 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 · 2h ago↗ source
  • STAT+: Pharmalittle: We’re reading about a Novartis heart drug, BIO fighting a Trump program, and more
    Novartis is largely abandoning a drug once considered a potential blockbuster after a study found it had little promise for preventing heart attacks and deaths
    STAT · 2h ago↗ source
  • Recent heart-drug trials miss endpoints, raising doubts about AI-driven drug design
    Two large clinical studies presented at the American Heart Association meeting this weekend failed to show any benefit for experimental heart‑attack and stroke therapies, underscoring the difficult…
    STAT · 1d agoNegative readoutNegative↗ source
  • Study finds training bystanders and responders does not boost survival after sudden cardiac arrest
    Sudden cardiac arrest kills about 350,000 people in the United States each year, and only one in ten victims survive. Survival depends heavily on rapid CPR and defibrillation by nearby bystanders o…
    STAT · 18h agoNegative↗ 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
  • Biotech Trade Group BIO Sues Over Medicare GLOBE Pricing Pilot
    BIO and two California biotech trade groups have filed a lawsuit in federal court to stop the Medicare GLOBE pilot that would tie US drug prices to those in peer nations. The complaint argues the…
    STAT · 2d agoRegulatoryNegative↗ source
  • Novo Nordisk’s anti-inflammatory drug ziltivekimab fails to cut heart events, but cardiologists still eye inflammation pathway
    Novo Nordisk reported that its experimental monoclonal antibody ziltivekimab lowered interleukin‑6 levels in the ZEUS trial but did not reduce heart attacks, strokes or cardiovascular deaths compar…
    STAT · 2d agoNegative readoutNegative↗ source