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14 stories matching this filter · ← front page

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  • Experts suggest new safety framework to boost predictability of CNS toxicity assessments
    A recent paper outlines a safety framework intended to make central nervous system (CNS) toxicity predictions more reliable during drug development. The authors argue that new approach methodologi…
    raps · 6d agoNeutral↗ source
  • Jazz Pharmaceuticals to acquire Actio Biosciences for $820 million upfront, targeting ultra-rare epilepsy
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences, a company developing an ultra‑rare epilepsy therapy. The transaction includes an upfront cash payment of $820 million, with the p…
    Endpoints · 13d agoDealPositive↗ source
73
fda recalls49
fda medwatch41
fda press28
918
Psychiatry & CNS729
Ophthalmology425
Pain406
Endocrinology & Metabolism390
Infectious Disease367
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda medwatch · 18d agoCRLNegative↗ source
  • Supernus and Indivior announce all-stock merger to create CNS-focused drugmaker
    Supernus Pharmaceuticals and Indivior Pharmaceuticals have signed an all‑stock merger agreement to combine their businesses. The new company will be dedicated to developing treatments for central…
    Endpoints · 20d agoDealPositive↗ source
  • MapLight's schizophrenia drug fails primary endpoint in Phase 2, sending stock down over 60%
    MapLight Therapeutics saw its shares tumble more than 60% after a mid‑stage trial showed that its once‑daily schizophrenia candidate did not meet the primary efficacy endpoint, even though the over…
    Endpoints · 27d agoNegative readoutNegative↗ source
  • EU regulators back Minoryx’s ALD therapy while rejecting Zevra’s rare-disease drug
    The EU Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Minoryx Therapeutics' drug for adrenoleukodystrophy, marking a significant regulatory step after previous c…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Roche halts development of Huntington’s disease drug tominersen after ten years of trials
    Roche announced it is stopping work on tominersen, its experimental therapy for Huntington’s disease. The decision follows a Phase 2 study in which the drug performed no better than placebo. The c…
    Endpoints · 1mo agoNegative↗ source
  • GSK terminates $700 million Alector partnership after recent trial setbacks
    GSK has decided to end its collaboration with Alector, a biotech focused on neurodegenerative diseases. The agreement originally included a $700 million upfront payment. The move follows two high-…
    Endpoints · 1mo agoDealNegative↗ source
  • Michel Detheux appointed CEO of Muna Therapeutics, GSK Alzheimer’s partner, as Genentech loses scientist Alex Hoffman
    Michel Detheux has taken over as chief executive of Danish neuro‑biotech Muna Therapeutics, succeeding Rita Balice‑Gordon in the role. Muna Therapeutics continues its collaboration with GlaxoSmith…
    Endpoints · 1mo agoNeutral↗ source
  • Shattuck raises $75M; Servier inks neuro ASO pact with n-Lorem Foundation
    Shattuck Labs initiates $75M public offering: The US biotech {$STTK} is selling over 10.5 million shares for $4 apiece, and issuing pre-funded warrants for certain investors. The offering is set to…
    Endpoints · 2mo ago↗ source
  • Sanofi to mull riliprubart’s future after stopping late-stage nerve disease study
    Sanofi is ending a Phase 3 trial of its antibody drug in a rare neurological disorder after an independent committee said the study was unlikely to show sufficient efficacy. The broader future of t…
    Endpoints · 2mo ago↗ source
  • Nurix to work with Roche on BTK degrader in pact worth up to $2.3B
    Roche is set to pay Nurix Therapeutics $700 million upfront to collaborate on a BTK degrader for B cell malignancies, with broader plans in immunology and neurology. The deal could be ...
    Endpoints · 2mo ago↗ source
  • Angelini fortifies neurology portfolio with $4.1B buyout of Catalyst
    Angelini Pharma is spending $4.1 billion to buy Catalyst Pharmaceuticals and its trio of FDA-approved treatments for rare neurological diseases. The buyout will add three medicines to Angelini’s po…
    Endpoints · 3mo ago↗ source
  • Q&A: Seaport CEO and CSO on learning from Karuna and the future of CNS research
    Seaport Therapeutics began trading as a public company on Friday after executives rang the Nasdaq’s opening bell. Shares rose {$SPTX} more than 20%. With a team largely made up of Karuna Therapeuti…
    Endpoints · 3mo ago↗ source