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  • Opioid Overdose Deaths Have Plummeted, Experts Call for Deeper Investigation
    Recent data indicate a steep drop in opioid overdose deaths. The decline is notable compared with previous years. Three health experts argue that influences beyond medical treatment and public hea…
    STAT · 17d agoPositive↗ source
  • STAT honors late infectious disease reporter Helen Branswell on The Readout LOUD podcast
    The Readout LOUD podcast dedicated an episode to remembering Helen Branswell, a well‑known infectious disease journalist who passed away last week. Colleagues, family, and public health leaders sh…
    STAT · 17d agoNegative↗ source
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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 · 17d agoNeutral↗ source
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • FDA launches Neuroscience Advancement and Innovation Nexus to boost brain disorder drug development
    The U.S. Food and Drug Administration announced a new program called the Neuroscience Advancement and Innovation Nexus (NAIN) aimed at accelerating the development of medical products for brain and…
    fda press · 18d agoRegulatoryPositive↗ 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
  • 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
  • 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
  • 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 · 18d 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 · 18d agoPositive↗ 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
  • 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
  • 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
  • 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 · 18d agoRegulatoryNeutral↗ source