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2,337 stories matching this filter · ← front page

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  • 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
  • Recon: Merck KGaA to exit CDMO business; Karyopharm to sell itself in bankruptcy
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 6d ago↗ 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…
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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 · 7d 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  • FDA issues draft guidance to streamline approval of personalized gene therapies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
  • FDA issues final guidance on potency standards for cell and gene therapy developers
    The U.S. Food and Drug Administration released a final guidance on Monday that sets out the expectations for sponsors of cell and gene therapies to demonstrate product potency. The document requir…
    raps · 7d agoRegulatoryNeutral↗ 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
  • Top pharma firms line up for Summit Therapeutics' ivonescimab after strong China Phase 3 data
    Several major biopharma companies, including AstraZeneca, Pfizer and Revolution Medicines, are expressing strong interest in Summit Therapeutics' Akeso-partnered bispecific antibody ivonescimab. Th…
    BioSpace · 7d agoDealPositive↗ source
  • Saudi Arabia pushes ahead with biotech hub despite regional instability
    Saudi Arabia is constructing a regulatory framework, partnership networks and intellectual property structures to nurture a biotech ecosystem, even as regional political tensions persist. Experts…
    BioSpace · 7d agoPositive↗ source
  • BridgeBio eyes first FDA approval for limb-girdle muscular dystrophy therapy
    BridgeBio Pharma is preparing for a potential launch of its experimental drug BBP-418 aimed at treating limb-girdle muscular dystrophy type 2I/R9, pending FDA decision. The agency has set a review…
    BioSpace · 7d agoRegulatoryPositive↗ source
  • AbbVie signs up to $757M deal with Beijing's Brise Pharma for two preclinical migraine candidates
    AbbVie announced a discovery and commercialization agreement with Brise Pharma, a Beijing-based biotech company. The partnership covers two preclinical migraine programs and is valued at up to $75…
    Endpoints · 6d agoDealNeutral↗ source
  • FDA approves generic lenacapavir for low-income markets; EMA to review Lundbeck's Deanxit over safety concerns
    The U.S. Food and Drug Administration has granted approval for a generic version of lenacapavir, a drug aimed at treating HIV, with the intention of making it available to lower-income countries.…
    raps · 7d agoApprovalNeutral↗ source
  • Karyopharm Therapeutics to merge with Ayrmid as it enters bankruptcy
    Karyopharm Therapeutics, a commercial-stage biotech focused on blood cancers, announced it will pursue a merger with Ayrmid while navigating a bankruptcy process. The move aims to combine the two c…
    Endpoints · 7d agoDealNeutral↗ source
  • U.S. bioscience jobs up 7% from 2021 to 2025: Report
    Bioscience employment rose in 41 states, though not in California, according to a new report from the Biotechnology Innovation Organization and the Council of State Bioscience Associations.
    BioSpace · 7d agoRegulatoryNeutral↗ source
  • CinRx partners with Graviton Bioscience to target ROCK2 in pulmonary arterial hypertension and other cardiovascular diseases
    CinRx announced a collaboration with Graviton Bioscience, led by Sam Waksal, to develop therapies that inhibit the ROCK2 enzyme. The partnership will focus on pulmonary arterial hypertension (PAH)…
    Endpoints · 7d agoDealNeutral↗ source
  • Study finds patient agreement forms match knowledge surveys, urging greater transparency in FDA’s mifepristone REMS
    A randomized controlled trial published in JAMA Internal Medicine examined how well patients understood medication abortion when they signed the FDA’s risk evaluation and mitigation strategy (REMS)…
    raps · 7d agoRegulatoryNeutral↗ source
  • Australian regulator opens consultation on clinical trial data sharing and ICH GCP guidance
    The Therapeutic Goods Administration (TGA) in Australia has launched a public consultation seeking input on how clinical trial information should be shared under existing schemes. The consultation…
    raps · 7d agoRegulatoryNeutral↗ source