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1,649 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 · 11h 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 · 22m agoRegulatoryNeutral↗ 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 · 2h agoNegative readoutNeutral↗ source
  • Phase II success does not guarantee easy Phase III launch, says Thermo Fisher
    Positive Phase II data often signals the start of Phase III planning, but the transition involves far more than simply adding patients and sites. When a trial expands into new countries, differenc…
    BioPharma Dive · 6h agoNeutral↗ source
  • State incentives can shape site decisions for commercial-stage life sciences firms
    The article advises commercial-stage life-science companies to consider state and local incentives early in expansion planning to improve site selection and preserve capital. Incentives most relev…
    BioPharma Dive · 6h agoNeutral↗ 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
  • Early technical expertise key to tackling complex life-science construction projects
    Life‑science construction projects often present problems that lack obvious solutions, such as retrofitting existing buildings, using unconventional materials, or fitting large process equipment in…
    BioPharma Dive · 6h agoPositive↗ 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
  • 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 · 27m ago↗ source
  • Ramaswamy’s biotech baggage haunted his political run
    A pivotal Alzheimer’s trial tied to Vivek Ramaswamy’s political rise is a tale of failed endpoints.
    BioPharma Dive · 36m 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 · 38m 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 · 49m 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
  • Novartis reports nine cancer cases in patients treated with Zolgensma gene therapy
    Novartis disclosed that nine individuals with spinal muscular atrophy who received its gene therapy Zolgensma later developed tumors. Two of the cases showed evidence that the adeno-associated vir…
    BioPharma Dive · 2d agoRegulatoryNegative↗ 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
  • Eli Lilly partners with Hims & Hers to sell Zepbound and Foundayo via telehealth platform
    Eli Lilly announced a partnership with Hims & Hers to make its obesity treatments Zepbound and Foundayo available through the telehealth service. The arrangement lets patients with a prescription…
    BioPharma Dive · 3d agoDealNeutral↗ source
  • Novo Nordisk’s oral Wegovy sales beat forecasts, boosting shares over 5%
    BioPharma Dive’s latest visualization series examines how investors reacted to three drug launches highlighted in recent quarterly earnings. Novo Nordisk reported that its oral Wegovy generated 5.…
    BioPharma Dive · 3d agoPositive readoutPositive↗ source
  • Forge Biologics VP sees AI and Ohio talent driving next wave of gene therapy manufacturing
    Samantha Piteri-Molina, vice president of business and strategy at Forge Biologics, said her focus is on getting gene therapies into patients' hands. She helped steer Forge through a $620 million…
    BioSpace · 3d agoPositive↗ source
  • Agios cuts over 35% of R&D staff as FDA decision on sickle cell drug is delayed
    Agios announced it will eliminate more than 100 R&D positions, representing over a third of its research staff, after the FDA postponed a decision on its sickle cell disease candidate. The company…
    BioSpace · 3d agoLayoffsNegative↗ source
  • Sarepta CEO Sees Path to Stronger DMD Trials Amid 2025 Elevidys Setbacks
    Sarepta Therapeutics’ newly appointed chief executive Michael Severino, after a 90‑day assessment period, outlined a plan to restore the company’s leadership in the Duchenne muscular dystrophy mark…
    BioSpace · 3d agoEarningsNeutral↗ source
  • Regulators urge risk-based lifecycle approach for AI tools amid election-linked FDA uncertainty
    A panel of regulatory experts at the RAPS AI in Regulatory Conference in Barcelona urged professionals using AI tools to adopt a risk-based, life-cycle perspective rather than focusing solely on va…
    raps · 3d agoRegulatoryNeutral↗ source
  • Verdicts for Summit/Akeso, Capricor, Vertex mark FDA’s stacked November
    Also lined up are target action dates for Sanofi’s Gaucher disease therapy, GSK’s lung cancer medicine and BridgeBio’s muscular dystrophy drug.
    BioSpace · 3d agoRegulatoryNeutral↗ source
  • Regulatory experts urge risk-based, lifecycle validation for AI tools in FDA work
    At the RAPS AI in Regulatory Conference in Barcelona, a panel of experts discussed the growing use of AI tools by regulatory professionals. They recommended a risk-based, lifecycle approach to val…
    raps · 3d agoRegulatoryNeutral↗ source