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  • Regulatory update: Hepatitis B hold lifted for Arbutus drug and Ultomiris receives accelerated approval
    A regulatory update notes that the FDA has removed the clinical hold on Arbutus Biopharma's hepatitis B candidate, clearing the path for the company to resume development after a prolonged review.…
    Endpoints · 18d agoRegulatoryPositive↗ source
  • Biotech sector logs 31 IPOs in 2026, with four more slated, still far below 2021 boom
    Biotech IPO activity has accelerated this year, with 31 companies completing public offerings so far, according to BioSpace data. This figure exceeds the totals from each of the previous four year…
    BioSpace · 19d agoDealNeutral↗ source
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  • AbbVie reports Phase 3 success for lutikizumab in painful skin disease, eyes FDA filing next year
    AbbVie announced positive Phase 3 trial results for its experimental IL-1α and IL-1β inhibitor lutikizumab, which is being developed to treat a debilitating skin condition. The study reported impr…
    Endpoints · 19d agoPositive readoutPositive↗ source
  • Sanofi breaks ground on new 36,000-sq-m insulin plant in Frankfurt
    Sanofi has broken ground on a new insulin manufacturing facility at its Frankfurt site, covering roughly 36,000 square meters. The plant is part of the company’s expansion in Germany and is expect…
    Endpoints · 19d agoNeutral↗ source
  • GLP-1 drugs enter trials to test impact on alcohol and drug cravings
    GLP-1 drugs, first approved for diabetes and later for obesity, have sparked interest for broader therapeutic uses. Researchers are now launching large clinical trials to evaluate whether these ag…
    Endpoints · 19d agoNeutral↗ source
  • Georgiamune to ship preclinical solid tumor drug to Menarini in deal up to $1.1 billion
    Georgiamune, a small biotech based in Maryland, announced that it will supply its preclinical solid tumor candidate to Menarini, a family‑owned pharmaceutical company in Italy. The agreement is st…
    Endpoints · 19d agoDealNeutral↗ source
  • Investors Re-evaluate Kidney Disease as New Cell and Gene Therapy Strategies Emerge
    In a recent episode of BioSpace's Denatured podcast, the CEOs of ProKidney and Nephrogen discussed why kidney disease has long been a difficult indication for cell and gene-based medicines. The co…
    BioSpace · 19d agoPositive↗ source
  • Roche touts strong Phase 3 track record while trimming pipeline amid peer setbacks
    Roche's chief executive Thomas Schinecker highlighted the company's high success rate in Phase 3 trials, positioning it as a competitive advantage. The comment accompanied an announcement that Roc…
    Endpoints · 19d agoPositive↗ source
  • Merck to showcase three late-stage TROP2 ADC trials at ESMO 2026, VP says payload is in the "Goldilocks zone"
    At the European Society for Medical Oncology meeting in 2026, Merck will present three late-stage trials of its TROP2‑directed antibody‑drug conjugate sac‑TMT, developed in partnership with Kelun‑B…
    BioSpace · 19d agoPositive↗ source
  • AMA chief urges regulators to keep pace with emerging AI-driven medical care
    The American Medical Association’s chief executive highlighted the rapid progress toward autonomous, AI‑based medical treatments and warned that regulatory frameworks are lagging behind. He emphasi…
    Endpoints · 18d agoRegulatoryNeutral↗ source
  • Healthcare groups and tech firms debate FDA evidence requirements for generative AI medical devices
    Healthcare stakeholders are questioning how much clinical evidence the FDA should demand before clearing generative AI-enabled medical devices. The debate centers on balancing innovation speed with…
    Endpoints · 19d agoRegulatoryNeutral↗ source
  • Redesign Health merges with ARC Global in $2B deal to help hospitals build startups
    Health tech venture firm Redesign Health is merging with ARC Global, the innovation arm of Sheba Medical Center, to help hospitals in different countries develop and sell software. The new company…
    Endpoints · 19d agoDealNeutral↗ source
  • Biopharma firms curb hiring as $100,000 H-1B visa fee limits foreign talent
    The U.S. Department of Homeland Security’s recent increase of the H-1B visa filing fee to $100,000 has made it much more expensive for biopharma employers to sponsor foreign-born scientists and eng…
    BioSpace · 19d agoRegulatoryNeutral↗ source
  • Roche’s pipeline trim claims Poseida’s off-the-shelf CAR T asset
    Aside from RG6540, Roche also discontinued a host of other early-stage assets, including an antisense oligonucleotide for Alzheimer’s disease and a small-molecule candidate for geographic atrophy.
    BioSpace · 19d agoRegulatoryNeutral↗ source
  • Key career moves that propelled three BioSpace 40 Under 40 honorees to biotech leadership
    BioSpace highlighted three members of its 40 Under 40 list, asking them to describe pivotal moments that shaped their biotech careers. Lex Johnson, chief platform officer at Dispatch Bio, said the…
    BioSpace · 19d agoPositive↗ source
  • US patients skip half of new high-cost drugs as prices surge past $250K
    A new report from the Institute for Clinical and Economic Review and West Health finds that only about one-third of patients prescribed newly launched medicines actually fill them within 30 days, w…
    BioSpace · 20d agoNegative↗ source
  • GSK and Ionis receive FDA nod for hepatitis B therapy promising functional cure
    GSK and Ionis announced that the U.S. Food and Drug Administration has approved their hepatitis B drug bepirovirsen, now marketed as Hibsago. The therapy is intended for chronic hepatitis B patien…
    Endpoints · 20d agoApprovalPositive↗ source
  • FDA approves GSK‑Ionis hepatitis B functional cure, Hibsago, targeting undetectable virus after six months
    The FDA has approved bepirovirsen, an antisense oligonucleotide from GSK and Ionis, for chronic hepatitis B infection. It will be sold under the brand name Hibsago. The therapy is described as a f…
    BioSpace · 20d agoApprovalPositive↗ source
  • US biotech M&A surges as Chinese licensing deals dominate 2026 market
    Locust Walk reports that China now accounts for 58% of global licensing deal value in 2026, while the United States share has dropped to 26%. Despite the licensing shift, US biotech companies are…
    BioSpace · 20d agoDealPositive↗ source
  • Disc Medicine’s Phase 3 data revives rejected rare‑disease drug as China tightens biotech ownership rules
    Disc Medicine announced that its Phase 3 trial of a previously rejected rare‑disease therapy showed positive results, effectively rescuing the program and positioning it for another submission to t…
    BioSpace · 20d agoPositive readoutPositive↗ source
  • Novo reports 25% average weight loss in women using CagriSema, with greatest loss in premenopausal patients
    Novo's next-generation GLP-1 drug CagriSema showed substantial weight loss in women enrolled in the Phase 3 REDEFINE 1 trial. Women in the study lost about 25% of their body weight after 68 weeks,…
    BioSpace · 20d agoPositive readoutPositive↗ source
  • Rezera files for IPO to fund NLRP3 peripheral artery disease program
    Rezera, which rebranded from NodThera earlier this year, has entered the queue for an initial public offering. The filing, submitted on Wednesday, is intended to raise capital to support the compa…
    Endpoints · 19d agoDealPositive↗ source
  • Treasury to tighten scrutiny of China biotech acquisitions under upcoming rules
    Treasury Secretary Scott Bessent announced on Sept 9 2026 that the Treasury Department will issue new guidance that makes it harder for U.S. pharma companies to complete biotech deals in China. Th…
    Endpoints · 19d agoRegulatoryNegative↗ source
  • FDA cites Baxter’s inadequate oversight after repeated GMP violations at multiple plants
    The U.S. Food and Drug Administration has issued a warning letter to Baxter International, saying the company's leadership has failed to provide adequate oversight of its drug manufacturing operati…
    BioSpace · 19d agoRegulatoryNegative↗ source
  • CSL appoints former ViiV and GSK veteran Deborah Waterhouse as new CEO
    CSL announced that Deborah Waterhouse will become its chief executive. The appointment follows her departure from GSK, where she spent three decades. Waterhouse most recently led ViiV Healthcare,…
    Endpoints · 19d agoPositive↗ source