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4,609 stories matching this filter · ← front page

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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 · 19d agoNeutral↗ source
  • Roche prepares launch of breast cancer pill giredestrant amid patient anticipation
    Roche is gearing up for the launch of its new oral breast cancer therapy, giredestrant. Teresa Graham, head of Roche's pharma unit, said patients are anxiously awaiting the drug. The announcement…
    Endpoints · 19d agoPositive↗ source
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FDA accepts new submission for Biohaven’s Vyglxia, opening path to approval
Biohaven announced that the FDA has accepted a refreshed application for its rare disease drug Vyglxia, which targets a nerve‑damaging disorder. Vyglxia is being developed for spinocerebellar atax…
BioPharma Dive · 19d agoRegulatoryPositive↗ source
  • Compounding pharmacy recalls copycat version of Eli Lilly’s Zepbound amid safety concerns
    Apothecary Pharma, a compounding pharmacy, has voluntarily recalled its compounded tirzepatide product that mimics Eli Lilly's obesity drug Zepbound. The company said it could not guarantee the saf…
    BioPharma Dive · 19d agoCRLNegative↗ source
  • Roche reaffirms sales outlook despite weaker Xolair sales and looming generic competition
    Roche reported third-quarter group sales of 16.1 billion Swiss francs, about $19.6 billion, a 7% increase that beat analysts' consensus estimate of 15.8 billion francs. The beat was helped by a ne…
    BioPharma Dive · 19d agoEarningsNegative↗ source
  • 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 · 19d 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 · 19d agoPositive↗ source
  • 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
  • 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 · 19d 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 · 19d agoPositive readoutPositive↗ 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
  • 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
  • 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 · 19d 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 · 19d 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
  • 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
  • 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 · 19d 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 · 19d agoRegulatoryNeutral↗ 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 · 19d 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 · 19d agoNeutral↗ 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