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  • EyePoint cuts half its staff and ends wet AMD trials after second Phase 3 failure, pivots to diabetic macular edema
    EyePoint said it is launching a strategic review after its investigational drug duravyu failed another Phase 3 study in wet age‑related macular degeneration. The company reported that the top‑line…
    BioSpace · 21d agoLayoffsNegative↗ source
  • Veradermics reports Phase 3 minoxidil pill boosts hair coverage in men
    After a February IPO that raised more than $256 million and a strong share rally, Connecticut‑based Veradermics now has late‑stage data for its oral minoxidil candidate. In the Phase 3 Study 304,…
    BioSpace · 21d agoPositive readoutPositive↗ source
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  • Merck/Moderna vaccine and Summit/Akeso bispecific therapy among key highlights at ESMO 2026
    The European Society of Medical Oncology (ESMO) meeting in Madrid this weekend will showcase several high‑profile oncology programs. Among the most watched are Merck and Moderna’s personalized can…
    BioSpace · 22d agoNeutral↗ source
  • Multispecific drug design faces growing complexity as more binding arms increase molecular options
    The industry is seeing a rapid rise in complex biologic formats such as trispecific antibodies and cell-engaging molecules. As these multispecific constructs multiply, drug developers are turning t…
    BioSpace · 22d agoNeutral↗ source
  • China proposes ban on biotech platform sales but keeps licensing deals open
    Chinese ministries of Commerce and Science and Technology released a draft policy that would prohibit the transfer of ownership for five biotech technologies, including cell and gene therapy, small…
    BioSpace · 21d agoRegulatoryNeutral↗ source
  • Experts tout amylin as promising, potentially gentler obesity target as new combo therapies near FDA review
    While GLP-1 medicines dominate the weight‑loss market, some observers argue that amylin would have been the logical primary target for obesity treatment a decade ago. Novo Nordisk’s amylin/GLP‑1 c…
    BioSpace · 22d agoPositive↗ source
  • Novartis halts Phase 2 lupus nephritis trial of Fabhalta, cites strategic reasons
    Novartis has stopped a Phase 2 study of its complement blocker Fabhalta (iptacopan) in patients with lupus nephritis, a kidney involving form of the disease. The company said the decision was base…
    BioSpace · 21d agoNeutral↗ source
  • Sino Biological offers validated cytokines to improve organoid culture and research
    Organoids are three-dimensional cell models that mimic key features of real tissues, and they rely on specific signaling molecules to grow and differentiate. Key cytokines such as R-spondin 1, EGF…
    BioSpace · 22d agoNeutral↗ source
  • Japan’s PMDA releases guidance on evaluating generative AI-enabled medical devices
    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a set of review points aimed at medical devices that incorporate generative artificial intelligence. The guidance outlines th…
    raps · 22d agoRegulatoryNeutral↗ source
  • MedTech firms grow more comfortable with FDA's Quality Management System Regulation amid inspection concerns
    At The MedTech Conference in Boston, a senior industry executive reported that the medtech sector is gradually accepting the new Quality Management System Regulation (QMSR) despite early worries.…
    raps · 22d agoRegulatoryNeutral↗ source
  • As AbbVie’s Crohn’s combo beats Skyrizi in mid-stage test, analysts laud autoimmune vision
    AbbVie’s next-gen dual-targeting therapy elicited higher rates of remission than its IL-23 inhibitor Skyrizi in a Phase 2a trial of Crohn’s disease, leading analysts to wonder if the blockbuster ca…
    BioSpace · 21d ago↗ source
  • Disc’s rebuffed rare disease drug sets up FDA redo after ‘clean’ Phase 3 sweep
    Disc Medicine’s bitopertin—rejected by the FDA in February—significantly reduced levels of a key disease biomarker and significantly increased the time patients with erythropoietic protoporphyria w…
    BioSpace · 21d ago↗ source
  • Induced pluripotent stem cells gain momentum as new methods and clinical successes drive drug development
    Induced pluripotent stem cells (iPSCs) are moving from a research curiosity to a practical tool in drug development. After years of steady progress, recent advances are bringing iPSCs into the spot…
    BioSpace · 24d agoPositive↗ source
  • FDA issues warning letters to drug makers over CGMP lapses and highlights patient rep ties to industry-backed groups
    The FDA has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practice requirements, citing problems with ensuring product sterility and meeting sp…
    raps · 25d agoRegulatoryNegative↗ source
  • FDA issues warning to Eurofins over selective microbiology data recording at Pennsylvania lab
    FDA sent a warning letter to Eurofins after inspectors found issues at its Horsham, Pennsylvania laboratory. The inspection revealed that analysts had been selectively recording results of pour-pl…
    BioSpace · 24d agoRegulatoryNegative↗ source
  • FDA issues warning letters to drug makers and a lab over CGMP and GLP violations
    FDA sent warning letters to several drug manufacturers for not meeting current good manufacturing practice (CGMP) requirements. The letters point to issues such as ensuring final product sterility…
    raps · 25d agoRegulatoryNegative↗ source
  • City Therapeutics raises $200M in IPO to fund thromboembolic disease pipeline
    City Therapeutics, an RNA interference biotech focused on thromboembolic diseases, completed an initial public offering that raised $200 million. The company sold about 11 million shares at $18 ea…
    BioSpace · 24d agoDealPositive↗ source
  • Lidl US recalls Gelatelli Coffee & Vanilla Gelato over possible Listeria contamination
    Lidl US announced a recall of one lot of its Gelatelli Coffee & Vanilla Gelato with coffee sauce and cookie pieces, citing potential contamination with Listeria monocytogenes. The affected product…
    fda recalls · 25d agoCRLNegative↗ source
  • Estuary sails into kidney disease space with $103M for gene therapies
    Estuary Biotherapeutics is seeking to address the root cause of autosomal dominant polycystic kidney disease with two gene therapy programs based on science from Yale.
    BioSpace · 24d ago↗ source
  • OrbiMed raises two new life sciences funds worth $3B with one aiming for Asia
    The sixth cycle of OrbiMed’s Asia Partners fund included one with more than $1 billion earmarked for life science companies based on the Eastern continent.
    BioSpace · 24d ago↗ source
  • AstraZeneca teams with insitro in up to $1.5 billion AI partnership to target MASH and cardiomyopathies
    AstraZeneca announced a partnership with AI-driven biotech insitro, committing up to $1.5 billion to discover new drug targets for metabolic dysfunction-associated steatohepatitis (MASH) and cardio…
    BioSpace · 25d agoDealPositive↗ source
  • Paul Stoffels launches Armed Cell Therapeutics, acquires Galapagos CAR-T assets for ~ $240 million
    Paul Stoffels, former J&J executive and ex‑CEO of Galapagos, has co‑founded a new Belgian biotech called Armed Cell Therapeutics. The company announced a licensing deal to acquire the CAR‑T cell t…
    BioSpace · 25d agoDealNeutral↗ source
  • Arrowhead’s siRNA shows strong tau reduction in early human study, outpacing other BBB platforms
    Arrowhead Pharmaceuticals reported that its investigational siRNA candidate ARO-MAPT produced notable reductions in cerebrospinal fluid tau in a Phase 1/2a trial of healthy volunteers. Doses of 2.…
    BioSpace · 25d agoPositive readoutPositive↗ source
  • Experts call for dedicated regulatory framework for clinical AI models, UK MHRA unveils AI-focused strategy
    Former FDA commissioner Scott Gottlieb, now at the American Enterprise Institute, wrote an opinion piece urging Congress to create a specific regulatory framework for artificial intelligence models…
    raps · 26d agoRegulatoryPositive↗ source
  • EMA to cement ACT EU pilot; MHRA unveils AI-era regulatory strategy
    The European Medicines Agency announced that in January 2027 it will make permanent a pilot project that assists sponsors in preparing clinical trial applications, turning a temporary scheme into a…
    raps · 26d agoRegulatoryNeutral↗ source