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  • AI drug developer Pathos secures $237 million Series E, valuation hits $3 billion
    Pathos announced a $237 million Series E round led by Bristol Myers Squibb, lifting its valuation to about $3 billion. The funding will support expansion beyond oncology into neurology, leveraging…
    STAT · 17d agoDealPositive↗ source
  • Few European-approved cancer drugs deliver high clinical benefit, analysis shows
    A new analysis of European regulator approvals between Jan 2022 and July 2026 finds that most newly approved cancer medicines provide limited clinical benefit. Out of 97 approved indications acros…
    STAT · 17d agoRegulatoryNegative↗ source
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  • Novartis MS drug remibrutinib cuts relapse rates by about a third in Phase 3 trials
    Data presented at an MS conference in Toronto showed that Novartis' experimental therapy, remibrutinib, reduced the annualized relapse rate in relapsing‑remitting multiple sclerosis by roughly 35%…
    STAT · 17d agoPositive readoutPositive↗ source
  • New Medicare rules could restrict pain medication access for many patients, doctor warns
    A recent Medicare policy proposal would tighten coverage criteria for certain pain‑relief treatments, potentially limiting their availability to patients who rely on them for daily functioning. Ph…
    STAT · 17d agoRegulatoryNegative↗ source
  • Alnylam's experimental Huntington's therapy reduces mutant protein in early trial
    Alnylam Pharmaceuticals reported early data from a small study of its gene‑silencing drug for Huntington's disease. The investigational agent, brezosiran, was administered at several dose levels.…
    STAT · 17d agoPositive readoutPositive↗ source
  • State officials scramble to roll out Medicaid work requirements, exchange strategies at NAMD conference
    At the National Association of Medicaid Directors (NAMD) conference, state officials gathered to discuss the rollout of Medicaid work requirements. Officials described the effort as a scramble, no…
    STAT · 17d agoRegulatoryNeutral↗ source
  • Family reflects on extra months gained from new pancreatic cancer drug daraxonrasib
    Bobby Senaha was among the first patients to receive daraxonrasib, a new medicine aimed at extending survival for people with pancreatic cancer. The drug is described as life extending, offering p…
    STAT · 17d agoPositive↗ source
  • Lung cancer patient credits targeted therapy for 15-year survival, notes limited benefit for others
    A lung cancer patient described how a targeted drug allowed her to live for 15 years after diagnosis. She highlighted that while her own quality of life improved, many of her peers who received th…
    STAT · 17d agoNeutral↗ source
  • Drug safety group petitions FDA to block marketing of unapproved compounded peptides; bipartisan bill seeks clinical trial reforms
    A drug safety advocacy group has filed a citizen petition with the FDA, asking the agency to stop the marketing of compounded peptide products that lack approval. A bipartisan group of lawmakers h…
    raps · 17d agoRegulatoryNeutral↗ source
  • Experts urge cultural shift and standards to unlock real-world evidence potential in medtech
    At The MedTech Conference in Boston, experts highlighted the need for a cultural shift to build trust between regulators and medtech firms when using real-world evidence (RWE) for device marketing.…
    raps · 17d agoNeutral↗ source
  • ADA admits unclear policies after ejecting members, sparks boycott and journal shutdown
    The American Diabetes Association ejected five members from a scientific session in New Orleans on June 5 and later issued two explanations, an apology and a summary of its internal review. The org…
    STAT · 17d agoNegative↗ source
  • Callio Therapeutics appoints Chris Hassig as chief scientific officer, coming from Boundless Bio
    STAT+ regularly highlights personnel changes across the pharmaceutical sector. In its latest column the outlet reports a new senior appointment at Callio Therapeutics. The company has hired Chris…
    STAT · 17d agoPositive↗ source
  • States Challenge New Medicaid Work Requirements in Boston Court
    A federal judge in Boston heard arguments from about two dozen states contesting the Biden administration’s new Medicaid work-requirement rule. The states claim Health Secretary Robert F. Kennedy…
    STAT · 17d agoRegulatoryNegative↗ source
  • 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
  • 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
  • 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 · 18d agoPositive↗ 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
  • 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 · 18d 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