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  • US Treasury proposes COINS Act rules that restrict biotech investment in China but leave big pharma licensing deals untouched
    The U.S. Treasury Department released draft regulations that add biotechnology to the Comprehensive Outbound Investment National Security (COINS) Act, labeling pharmaceutical compounds as prohibite…
    Fierce Biotech · 18d agoRegulatoryNeutral↗ source
  • Merck and Moderna cancer vaccine data leak shows modest benefit, shares slide
    A data leak ahead of the European Society of Medical Oncology meeting revealed early results for the personalized cancer vaccine intismeran autogene combined with Merck's Keytruda. The information…
    BioSpace · 18d agoNegative readoutNegative↗ source
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  • CSL appoints GSK veteran Deborah Waterhouse as new CEO to steer company through challenges
    CSL announced that Deborah Waterhouse, former head of GSK's HIV business ViiV Healthcare and former president of GSK Global Health, will become its new chief executive. Waterhouse joins CSL as the…
    Fierce Biotech · 18d agoNeutral↗ source
  • Biohaven's ataxia drug resubmission accepted by FDA, shares surge 36%
    Biohaven’s experimental drug troriluzole, being developed for spinocerebellar ataxia, was previously rejected by the FDA because the agency questioned the design of the registrational trial. The co…
    BioSpace · 18d agoRegulatoryPositive↗ source
  • Medrio aims to unify clinical trial tools to ease complexity for biotech firms
    Mike Novotny, founder and CEO of Medrio, says that funding cycles, growing study complexity and fragmented technology are slowing clinical research, especially for small and midsize life‑science co…
    Fierce Biotech · 18d agoPositive↗ 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 · 18d agoDealNeutral↗ source
  • FDA issues final guidance on drug-related mobile applications
    The FDA has released its final guidance addressing software applications that are used in connection with prescription drugs. The guidance clarifies how the agency will evaluate and regulate apps…
    STAT · 18d agoRegulatoryNeutral↗ source
  • Zentalis reports promising overall survival and response rates for oral WEE1 inhibitor azenosertib in platinum-resistant ovarian cancer
    Zentalis Pharmaceuticals presented early data from the phase 1b portion of its Denali study of azenosertib, an oral WEE1 tyrosine kinase inhibitor, in patients with platinum‑resistant ovarian cance…
    Fierce Biotech · 18d agoPositive readoutPositive↗ 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 · 18d agoPositive↗ source
  • Researchers identify cellular stress trigger behind Angelman syndrome
    Researchers at Washington University School of Medicine in St. Louis reported a new mechanism linking loss of the maternal UBE3A gene to neuronal stress in Angelman syndrome. The study, published…
    Fierce Biotech · 18d agoPositive↗ source
  • Quest Diagnostics reports cyberattack that may have exposed patient records
    Quest Diagnostics disclosed in an SEC filing that its Quanum LSM system was accessed without authorization on Oct 21, potentially compromising patient data. The breach affected a system used by ce…
    Fierce Biotech · 18d agoRegulatoryNegative↗ source
  • Rebranded Rezera plans IPO to fund phase 3 trial of NLRP3 inhibitor ruvonoflast for peripheral artery disease
    Rezera, which rebranded from NodThera last month, announced plans for an initial public offering to raise capital for its lead candidate, ruvonoflast, a brain‑penetrant NLRP3 inhibitor. The compan…
    Fierce Biotech · 19d agoDealPositive↗ source
  • Roche CEO says stance on $1.5B Poseida acquisition unchanged despite dropping one CAR-T program
    Roche bought Poseida in 2024 for $1.5 billion to secure its off-the-shelf CAR-T platform and strengthen its cell-therapy portfolio. During the third-quarter earnings call, the company said it has…
    Fierce Biotech · 19d agoDealNeutral↗ 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
  • GSK’s B7-H4 ADC shows 62% response in platinum-resistant ovarian cancer, PFS 11 months
    GSK’s global head of oncology R&D presented new early-stage data on its B7-H4‑directed antibody‑drug conjugate, mo‑rez, at the ESMO conference in Madrid. The update focused on the ongoing Behold‑1…
    Fierce Biotech · 19d agoPositive readoutPositive↗ source
  • FDA issues warning letters to Baxter and Olympus over GMP and QSR violations
    The U.S. Food and Drug Administration sent formal warning letters to Baxter International and Olympus Medical Systems. The letters allege that both companies failed to meet required good manufactu…
    raps · 19d agoRegulatoryNegative↗ source
  • AbbVie’s lutikizumab meets primary endpoint in Phase 3 hidradenitis trial but falls short of market expectations
    AbbVie announced that its experimental drug lutikizumab achieved its primary goal in a Phase 3 study of hidradenitis suppurativa, a chronic inflammatory skin disease. The Intrepid trial enrolled a…
    STAT · 18d agoPositive readoutNegative↗ source
  • Treasury rumored to consider rule limiting U.S. investment in Chinese biotech
    A report says the U.S. Treasury is expected to propose a regulation that would curb American investment in China’s biotech sector. The story notes the proposal is still a rumor and no formal rule h…
    STAT · 18d agoRegulatoryNeutral↗ source
  • Moderna and Merck prepare to unveil cancer vaccine data at ESMO Congress
    Adam Feuerstein reports from the European Society for Medical Oncology meeting in Madrid that the long‑awaited data from the Moderna‑Merck cancer vaccine partnership will be presented in the coming…
    STAT · 18d agoNeutral↗ source
  • AbbVie’s lutikizumab meets primary endpoint in phase 3 hidradenitis suppurativa trial but falls short of competitive benchmarks
    AbbVie reported that its experimental antibody lutikizumab achieved the primary endpoint in the phase 3 Intrepid study for hidradenitis suppurativa. The trial enrolled about 1,400 patients and at…
    Fierce Biotech · 18d agoPositive readoutNeutral↗ source
  • Boehringer presents phase 1b data on obrixtamig showing strong response rates in second-line small cell lung cancer
    Boehringer Ingelheim presented updated data from its DAREON-9 phase 1b trial at the ESMO Congress in Madrid, evaluating the DLL3xCD3 bispecific T-cell engager obrixtamig in combination with topotec…
    Fierce Biotech · 18d agoPositive readoutPositive↗ source
  • Telehealth platforms prescribe GLP-1 drugs off-label for addiction, raising safety concerns
    Telehealth companies have begun prescribing GLP-1 receptor agonists, originally approved for diabetes and obesity, to patients with alcohol, cocaine, methamphetamine or other substance use disorder…
    STAT · 18d agoNeutral↗ 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
  • Abbott to separate Nutrition business into independent publicly traded company
    Abbott announced it will separate its Nutrition business into a stand-alone publicly traded company. The spin‑off will be carried out via a tax‑free distribution of the new company's shares to Abb…
    Fierce Biotech · 19d agoNeutral↗ source
  • Ipsen executive urges scientists to look beyond first results to achieve patient impact
    Philippe Lopes-Fernandes, executive vice president and chief business officer at Ipsen, reflects on how scientific progress often requires moving past an initial finding. He notes that a result can…
    Fierce Biotech · 18d agoPositive↗ source