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  • 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 · 10d 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 · 10d agoDealNeutral↗ source
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  • Four major drugmakers allegedly paid tens of millions to Russian middlemen for lifesaving drugs, limiting patient access
    Four large pharmaceutical companies are accused of funneling tens of millions of dollars to Russian intermediaries to deliver essential medicines to government agencies, according to a report by th…
    STAT · 10d agoRegulatoryNegative↗ source
  • Kymera Therapeutics to unveil mid‑stage eczema trial data, aiming to challenge Dupixent
    Kymera Therapeutics, a Massachusetts‑based biotech, is set to release data from its mid‑stage clinical trial of KT‑621 in eczema before the end of 2026. The trial results are being closely watched…
    STAT · 10d agoPositive readoutNeutral↗ 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 · 10d agoRegulatoryNegative↗ source
  • Karyopharm files for Chapter 11 and plans auction with Gamida Cell parent Ayrmid as lead bidder
    Karyopharm Therapeutics, a cash-strapped cancer drugmaker, announced a Chapter 11 filing on Monday and will conduct a court-supervised auction of the company. Ayrmid, the parent of cell-therapy co…
    BioPharma Dive · 10d agoDealNegative↗ source
  • AstraZeneca outlines restructuring as earnings show cost cuts, while Alnylam slides and Regeneron posts record quarter
    AstraZeneca said it will redeploy resources through a new restructuring program aimed at cutting costs while staying on track to hit its long‑term revenue goal of $80 billion by 2030. The company h…
    BioPharma Dive · 10d agoEarningsNeutral↗ 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 · 10d agoRegulatoryNeutral↗ source
  • U.S. Health Care System's Economics Are Broken, Says Ascendiun CEO
    Paul Markovich, president and CEO of Ascendiun, argues that the economics of the United States health care system are fundamentally broken. He recounts meeting a healthy, active man in his early 6…
    STAT · 10d agoNegative↗ 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 · 10d 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 · 9d agoNegative↗ source
  • Washington resident dies after bird flu infection linked to dairy cattle exposure
    A resident of Yakima County, Washington, died from complications of avian influenza after being exposed to infected cattle at a dairy farm. Health officials said the infection was the H5N1 strain,…
    STAT · 9d 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 · 10d 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 · 10d 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 · 10d 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 · 10d agoRegulatoryNegative↗ source
  • FDA accepts first Keytruda biosimilar application as Merck faces looming patent cliff
    The U.S. Food and Drug Administration has accepted the first publicly announced filing for a Keytruda biosimilar, identified as FYB206, which could receive approval as early as the third quarter of…
    BioPharma Dive · 10d agoRegulatoryNeutral↗ source
  • Woman travels to Albania for experimental mitochondrial replacement therapy amid global fertility industry concerns
    A STAT reporter detailed a case of a woman named Heidy Willis who, after multiple failed IVF cycles, sought an experimental fertility option abroad. Willis traveled to Albania to undergo mitochond…
    STAT · 10d agoNegative↗ 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 · 10d agoRegulatoryNeutral↗ source
  • Pharma leaders turn to integrated scenario modeling as US MFN pricing reshapes global launch strategies
    The article explains that integrated scenario modeling is becoming a key tool for pharmaceutical executives facing pricing uncertainty and the complexities of worldwide product launches. It refere…
    BioPharma Dive · 10d agoNeutral↗ source
  • Women travel abroad for unproven three-parent IVF marketed to older patients
    STAT investigators found that women are journeying thousands of miles to undergo a mitochondrial‑replacement IVF procedure that is promoted as a fertility option for older patients, even though the…
    STAT · 10d agoNegative↗ 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 · 10d 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 · 10d 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 · 10d 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 · 9d agoDealNeutral↗ source