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  • Servier’s $1.5 billion muscular dystrophy drug sevasemten fails pivotal trial
    Servier announced that its experimental muscular dystrophy therapy sevasemten did not meet its goals in a pivotal Phase III study. The trial, named GRAND CANYON, evaluated the drug’s ability to im…
    Endpoints · 5d agoNegative readoutNegative↗ source
  • Neurocrine launches new safety study after another death linked to Prader-Willi drug Vykat
    Neurocrine Biosciences announced it will start a new study to evaluate dosing and safety of its rare disease drug Vykat in patients with Prader-Willi syndrome who have complex health issues. The m…
    BioSpace · 6d agoRegulatoryNegative↗ source
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  • Ultragenyx cuts 20% of workforce and abandons Wilson disease gene therapy after mixed Q3 results
    Ultragenyx said it will cut about 20% of its workforce, marking a second round of layoffs this year. The reductions will affect roughly a fifth of the company's employees. At the same time, the fi…
    Endpoints · 5d agoLayoffsNegative↗ source
  • Pfizer partners with Sciwind to launch GLP-1 obesity drug Ecnoglutide in China
    Pfizer is entering China's obesity market with a new GLP-1 drug, Ecnoglutide, in partnership with Sciwind Biosciences. The New York-based company secured mainland China licensing rights to the inj…
    BioSpace · 5d agoDealPositive↗ source
  • Live discussion to assess how US midterm elections could reshape biopharma policy
    Drew Armstrong, executive editor of PharmaFDA+, announced a live webcast at 1:30 pm ET on November 3, 2026 to discuss the impact of the US midterm elections on biotech and pharma. The program will…
    Endpoints · 5d agoNeutral↗ source
  • Lonza to acquire five Merck KGaA US facilities, more than doubling its US footprint
    Lonza, a Swiss contract development and manufacturing organization, announced it will purchase five U.S. manufacturing sites from Merck KGaA. The transaction is valued in the low‑ to mid‑triple‑di…
    BioSpace · 6d agoDealPositive↗ source
  • Novartis ends $772M BioArctic brain-delivery partnership
    Novartis has terminated its neurodegeneration alliance with BioArctic, a partnership that was valued at more than $772 million. The collaboration focused on using BioArctic’s BrainTransporter techn…
    BioSpace · 6d agoDealNegative↗ source
  • Pfizer reports flat Q3 revenue as non-COVID sales rise 7% and acquired products grow 32%
    Pfizer posted third‑quarter revenue of $16.6 billion, essentially unchanged from $16.7 billion a year earlier. The flat top line reflects declines in its legacy Prevnar vaccine and COVID‑related pr…
    BioSpace · 6d agoEarningsNeutral↗ source
  • Merck KGaA sells its CDMO business and US sites to Lonza
    Merck KGaA announced it will divest its contract development and manufacturing organization (CDMO) operations, transferring ownership of five U.S. manufacturing facilities to Lonza. The transactio…
    Endpoints · 6d agoDealNeutral↗ source
  • Bayer CEO says company is negotiating a most-favored-nation trade pact with US administration
    Bayer chief executive Bill Anderson announced the drugmaker is actively pursuing a most-favored-nation (MFN) agreement with the United States. The comment signals that Bayer is in talks with the T…
    Endpoints · 6d agoRegulatoryNeutral↗ source
  • Pfizer CEO says Democratic gains unlikely to alter Trump-era MFN pricing agreements
    Pfizer chief Albert Bourla told reporters that he does not anticipate any changes to the most‑favored‑nation pricing arrangements that were put in place under the Trump administration, even if the…
    Endpoints · 5d agoRegulatoryNeutral↗ source
  • Novartis ends discovery-stage collaboration with BioArctic amid broader biotech updates
    Novartis announced it is terminating its discovery-stage partnership with Swedish biotech BioArctic. The decision ends joint work that was focused on early‑stage research. BioArctic is best known…
    Endpoints · 6d agoNeutral↗ source
  • Endpoints Announces Second Annual Health Tech Day with Virtual Sessions
    On Thursday, Endpoints will hold its second Health Tech Day, an event that brings together leaders in digital health. Lydia Ramsey Pflanzer, the deputy editor, says she looks forward to traveling…
    Endpoints · 6d agoNeutral↗ source
  • FDA sets May 1 decision date for uniQure's Huntington's disease gene therapy after year-long regulatory saga
    The U.S. Food and Drug Administration has accepted uniQure's biologics license application for its Huntington's disease gene therapy and placed it on the priority review track, with a May 1 target…
    BioSpace · 7d agoRegulatoryPositive↗ source
  • WuXi Biologics and Fresenius strike major deal for up to 37 biosimilars over the next decade
    WuXi Biologics and German drugmaker Fresenius have agreed to collaborate on the development and manufacturing of up to 37 biosimilar medicines over the next ten years. The agreement is described a…
    Endpoints · 6d agoDealPositive↗ source
  • Cell and gene therapy funding climbs to $2.2 billion in Q3 despite safety setbacks in CAR-T trials
    Sail Biomedicine’s $925 million agreement with Johnson & Johnson helped lift venture capital money into the cell and gene therapy (CGT) space during the third quarter. CGT attracted $2.2 billion a…
    BioSpace · 7d agoDealNeutral↗ source
  • FDA policy allowing compounding of unapproved peptides raises safety and development concerns
    The Department of Health and Human Services recently approved the compounding of six peptide products that have not received FDA approval. This move expands the list of bulk substances that traditi…
    BioSpace · 6d agoRegulatoryNegative↗ source
  • FDA issues final guidance on potency assurance for cell and gene therapy manufacturers
    The FDA released final guidance today outlining a science- and risk-based Potency Assurance Strategy for cellular and gene therapy (CGT) products. The guidance replaces the agency’s 2011 potency t…
    fda press · 7d agoRegulatoryNeutral↗ source
  • FDA issues draft guidance to streamline approval of personalized gene therapies
    The FDA released a draft guidance that outlines an "adapted pathway" for regulating gene‑edited medicines. The new framework is intended to speed the development and approval of personalized gene t…
    BioSpace · 7d agoRegulatoryPositive↗ source
  • Karyopharm files for Chapter 11 bankruptcy as it pursues merger with Ayrmid
    Karyopharm Therapeutics has filed for Chapter 11 bankruptcy while seeking a merger with U.K. biotech Ayrmid. The court‑supervised process is intended to provide a financial lifeline for the company…
    BioSpace · 6d agoNegative↗ source
  • Sun Pharma halts eye-care drug production in India after regulator cited quality failures
    Sun Pharma has stopped manufacturing eye-care medicines at its Assam facility after Indian regulators identified failures in the company's quality management system. The company previously recalle…
    BioSpace · 7d agoRegulatoryNegative↗ source
  • FDA sets May 1 decision deadline for UniQure’s Huntington’s disease gene therapy after advisory committee meeting
    The U.S. Food and Drug Administration announced that it has set a review date and scheduled an advisory committee meeting for UniQure’s gene therapy aimed at treating Huntington’s disease. The age…
    Endpoints · 7d agoRegulatoryNeutral↗ source
  • Tiziana's lower-dose foralumab cuts neuroinflammation in SPMS, but higher dose fails
    Tiziana Life Sciences reported that its intranasal anti‑CD3 antibody, foralumab, lowered a neuroinflammation biomarker in patients with non‑active secondary progressive multiple sclerosis when give…
    BioSpace · 7d agoNegative readoutNegative↗ source
  • FDA places Bright Minds seizure drug BMB-101 on partial hold over mouse toxicity, shares plunge
    The U.S. Food and Drug Administration issued a partial clinical hold on BMB-101, an experimental seizure treatment from Bright Minds Biosciences, after regulators identified toxicity concerns in pr…
    Endpoints · 7d agoRegulatoryNegative↗ source
  • FDA accepts review of Biohaven’s ataxia drug, boosting shares as ArriVent’s lung cancer trial miss drags its stock down
    Biohaven saw its shares jump after the FDA agreed to review its rare‑disease drug for spinocerebellar ataxia. The regulator’s decision lifted the stock by roughly 25% in late October, offering the…
    BioSpace · 7d agoRegulatoryNeutral↗ source