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  • Writer empathizes with Christina Applegate’s MS misdiagnosis, recalling her own 13-year diagnostic journey
    The author of the piece shares a personal connection to actress Christina Applegate’s recent revelation that she was told she no longer had multiple sclerosis, only to discover the news was a misdi…
    STAT · 17d agoNeutral↗ source
  • STAT reporters share reactions to new Elizabeth Holmes documentary
    STAT reporters attended the newly released documentary "You Can See Everything," which chronicles the rise and fall of Elizabeth Holmes and her company Theranos. The reporters offered a range of h…
    STAT · 18d agoNeutral↗ source
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STAT+: Highly anticipated Moderna-Merck melanoma cancer vaccine data arrived early
In data released at ESMO, the Moderna-Merck personalized mRNA cancer vaccine reduced recurrence-free survival and the time until distant metastasis occurred.
STAT · 17d ago↗ source
  • Gilead shops in IL-23, inking $1.3B upfront I&I deal with China’s PepStar
    Gilead Sciences has picked up a new inflammatory disease program from China’s PepStar Therapeutics to pair with the Phase 2 inflammatory bowel disease asset emvistegrast.
    BioSpace · 17d ago↗ source
  • STAT+: Treasury proposes major restrictions to U.S. investment in Chinese biotech sector
    A new Treasury Department proposal would restrict U.S. investments in Chinese biotechs, but still allows licensing deals.
    STAT · 17d ago↗ source
  • FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concerns
    After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aa…
    BioSpace · 17d ago↗ source
  • FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concerns
    After cardiac safety signals led to a full clinical hold on Aardvark Therapeutics’ studies of ARD-101, the biotech conducted an additional safety study, in which no cardiac events were detected. Aa…
    BioSpace · 17d ago↗ source
  • FDA approves GSK-Ionis antisense drug Hibsago, opening functional-cure market for hepatitis B
    The U.S. Food and Drug Administration has granted approval to Hibsago (bepirovirsen), a partnership product of GSK and Ionis Pharmaceuticals, marking the first antisense oligonucleotide cleared for…
    BioSpace · 18d agoApprovalPositive↗ source
  • Roivant's brepocitinib cuts steroid use in non-infectious uveitis in Phase 3 trials
    Roivant Sciences and its subsidiary Priovant reported that their TYK2/JAK inhibitor brepocitinib met all primary and secondary endpoints in two identical Phase 3 studies (Clarity‑1 and Clarity‑2) i…
    BioSpace · 19d agoPositive readoutPositive↗ source
  • Moderna and Merck's mRNA melanoma vaccine cuts recurrence risk by 42% in trial
    A large Phase 2 trial led by Moderna and Merck showed that their personalized mRNA vaccine, intismeran autogene, lowered the chance of melanoma returning by 42% compared with standard therapy. The…
    STAT · 18d agoPositive readoutPositive↗ source
  • AbbVie’s HS drug lutikizumab meets Phase 3 goal but falls short of analyst expectations
    AbbVie reported that its investigational IL‑1α/β inhibitor lutikizumab achieved the primary endpoint in the Phase 3 INTREPID study for hidradenitis suppurativa, a chronic inflammatory skin disease…
    BioSpace · 18d agoNegative readoutNegative↗ source
  • Merck and Moderna’s cancer vaccine data leak precedes official Phase 3 results release
    Results from the Phase 3 trial of Moderna and Merck’s therapeutic cancer vaccine were made public on Thursday after an earlier leak of the data. The vaccine, called intismeran autogene, is being e…
    Endpoints · 18d agoNeutral↗ source
  • U.S. proposes rule tightening review of biotech licensing deals with Chinese firms
    The U.S. is preparing to issue a proposed rule that would place additional scrutiny on outbound licensing agreements between American biotech firms and Chinese companies. The measure aims to increa…
    STAT · 18d agoRegulatoryNeutral↗ source
  • FDA approves GSK hepatitis B drug; EQT to acquire Qiagen for $10.8 billion
    The U.S. Food and Drug Administration has granted approval to GlaxoSmithKline's new hepatitis B therapy, marking a regulatory milestone for the company. Private-equity firm EQT announced a definit…
    raps · 19d agoPositive↗ source
  • US Treasury drafts rules to curb American investment in Chinese biotech firms
    The Treasury Department has released draft regulations that would impose broad restrictions on U.S. companies and venture capital firms investing in or acquiring drug and biotechnology assets linke…
    Endpoints · 18d agoRegulatoryNegative↗ 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
  • Pfizer and Valneva report mixed results for Lyme disease vaccine, with one analysis narrowly missing efficacy
    New data on the collaborative Lyme disease vaccine from Pfizer and Valneva were presented, showing divergent outcomes across two key analyses. One analysis met its predefined endpoints, while the o…
    Endpoints · 18d agoNegative readoutNegative↗ 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 · 18d agoPositive↗ 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
  • 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 · 18d agoDealNeutral↗ 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 · 18d 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 · 18d 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 · 18d 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 · 18d agoRegulatoryNeutral↗ source