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2,736 stories matching this filter · ← front page

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  • 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
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  • 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
  • Star raises $200 million after successful spinouts of Electra and Vega Therapeutics
    Star, a biopharma company, announced it has secured $200 million in new funding. The capital follows the recent exits of its subsidiaries Electra Therapeutics and Vega Therapeutics, which were spu…
    BioPharma Dive · 17d agoDealPositive↗ 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 vaccine plus Keytruda cuts melanoma relapse risk by 42% in late-stage trial
    A late-stage adjuvant study of Moderna’s experimental melanoma vaccine, intismeran autogene, combined with Merck’s Keytruda showed a 42% reduction in the risk of relapse or death compared with Keyt…
    BioPharma Dive · 18d agoPositive readoutNeutral↗ 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 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
  • 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 · 18d 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 · 18d 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 · 18d agoEarningsNegative↗ source