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  • 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 · 1d 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 · 1d agoPositive↗ source
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  • 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 1d 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 · 4d 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 · 4d 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 · 4d 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 · 4d 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 · 4d agoDealPositive↗ 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 · 4d 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 · 4d 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 · 5d 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 · 5d 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 · 5d 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 · 5d 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 · 5d agoRegulatoryNeutral↗ source
  • FDA unveils new rare disease framework to streamline evidence standards and speed therapies
    The FDA announced a new Rare Disease Framework Initiative aimed at standardizing how scientific evidence is evaluated for rare disease therapies. The framework seeks to apply consistent clinical t…
    BioSpace · 5d agoRegulatoryPositive↗ source
  • Vanda halts Novartis-originated social anxiety drug after Phase 3 miss
    Vanda Pharmaceuticals announced it is suspending development of VQW-765, a social anxiety disorder candidate licensed from Novartis, after the drug failed to demonstrate a statistically significant…
    BioSpace · 5d agoNegative readoutNegative↗ source
  • FDA issues warning letters to manufacturers over CGMP and GLP violations
    The U.S. Food and Drug Administration has sent warning letters to multiple drug manufacturers for failing to meet current good manufacturing practice requirements. The agency highlighted problems e…
    raps · 5d agoRegulatoryNegative↗ source
  • Experts call for Congress to create a dedicated regulatory framework for AI models used in academic medical centers
    On Oct. 15, 2026, several health policy experts voiced support for a new regulatory approach specifically aimed at clinical artificial‑intelligence models that are developed and deployed in academi…
    raps · 5d agoRegulatoryNeutral↗ source
  • Webinar Explores How US Biotechs Can Compete and Collaborate with China’s Growing Industry
    BioSpace is hosting a webinar titled "The China question: Can US biotechs lead as investment heads east?" on October 15, 2026. The event will feature a panel of experts who will discuss how China i…
    BioSpace · 5d agoNeutral↗ source