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  • 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
  • Massachusetts jury awards former MIT professor David Sabatini $6 million in defamation case
    A Massachusetts jury has ordered a $6 million damages award to David Sabatini, a former professor at MIT and noted biologist. The verdict stems from a defamation lawsuit that Sabatini filed after…
    Endpoints · 21d agoNeutral↗ 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 · 22d 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
  • Philips issues updated use instructions for Lumify ultrasound systems after software glitch risk
    Philips Ultrasound has sent a letter to customers of its Lumify diagnostic ultrasound system, advising that the devices require updated use instructions. The update addresses a software applicatio…
    fda medwatch · 22d agoCRLNegative↗ 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 · 22d ago↗ source
  • AbbVie’s Skyrizi combo beats Skyrizi alone in mid-stage Crohn’s trial
    AbbVie’s Skyrizi-based combination therapy for inflammatory bowel disease worked better than Skyrizi alone in a mid-stage trial in Crohn’s disease, the company said Monday. The new product is coden…
    Endpoints · 22d 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 · 22d ago↗ source
  • Endpoints Weekly highlights search for Alzheimer’s ‘statin’, Arrowhead’s tau-lowering injectable and AI Day recap
    Endpoints Weekly released its latest edition, previewing several biotech stories including a quest for a “statin of Alzheimer’s” and new data on Arrowhead’s injectable therapy that reduces tau prot…
    Endpoints · 24d agoNeutral↗ 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 · 25d agoPositive↗ source
  • City Therapeutics raises $200 million in IPO, becoming 26th biotech listing of 2026
    City Therapeutics announced that it has completed a $200 million initial public offering, making it the 26th biotech to go public in 2026. The company, based in Kendall Square, will begin trading…
    Endpoints · 25d agoDealPositive↗ 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
  • Novartis ends mid-stage Fabhalta trial in lupus nephritis citing strategic considerations
    Novartis has terminated its mid-stage trial of Fabhalta (iptacopan) in patients with lupus nephritis, according to a federal clinical trials registry. The company said the decision was driven by s…
    Endpoints · 25d agoCRLNegative↗ source
  • EU regulators endorse Eli Lilly’s oral GLP-1 pill orforglipron
    The European Medicines Agency’s human medicines committee (CHMP) has given a positive opinion on Eli Lilly’s oral GLP-1 medication, orforglipron, providing the drug with EU regulatory backing. The…
    Endpoints · 25d agoRegulatoryNeutral↗ 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 · 25d 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
  • Sanofi appoints former Roche exec Paulo Fontoura as global R&D head, eyes AI and dealmaking
    Sanofi announced that Paulo Fontoura, who spent 16 years at Roche and most recently worked at AI drug discovery startup Xaira Therapeutics, has become the company’s global head of R&D as of Septemb…
    Endpoints · 25d agoNeutral↗ source
  • China moves to ban export of select biotech platforms while keeping drug licensing open
    Chinese Ministry of Commerce announced it is pursuing an export ban on certain biotechnology platforms. The measure is intended to restrict the types of deals domestic companies can make abroad, r…
    Endpoints · 25d agoRegulatoryNeutral↗ 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 · 25d agoDealPositive↗ source
  • FDA reviews interim access policy for compounded peptides as Enspryng label expands
    The U.S. Department of Health and Human Services and the Food and Drug Administration have drafted a new interim access policy that would allow compounding pharmacies to use certain peptide drugs u…
    Endpoints · 25d agoRegulatoryNeutral↗ source
  • Eli Lilly signals interest in researching and improving psychedelic ibogaine, says neuroscience chief
    At a recent psychedelics conference, Eli Lilly’s neuroscience president Carole Ho announced the company’s interest in studying ibogaine. Ho said Lilly aims to improve the drug’s safety and efficac…
    Endpoints · 25d agoPositive↗ source
  • Study shows clinicians increasingly turn to AI for medical queries despite limited evidence of impact
    New research examined usage data from OpenEvidence, an AI search platform, to track how clinicians use AI to answer medical questions. Findings show a rapid increase in the frequency of AI queries…
    Endpoints · 25d agoNeutral↗ source
  • Former Genentech researcher Lélia Delamarre appointed head of R&D at Medici Therapeutics; Intellia hires Scholar Rock CMO
    Lélia Delamarre, a former senior scientist at Genentech, announced on LinkedIn that she will lead research and development at Medici Therapeutics, a cancer‑focused biotech backed by ARCH venture pa…
    Endpoints · 25d agoNeutral↗ source