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  • CDC warns Ebola could swell to 20,000 cases in Central Africa without rapid containment
    The U.S. Centers for Disease Control and Prevention released a new analysis indicating that the Ebola outbreak in Central Africa could expand to as many as 20,000 cases if infected individuals are…
    STAT · 4mo agoNegative↗ source
  • HHS reclassifies 8,000 staff under Schedule F, easing firing rules and raising political pressure
    An executive order issued in late June reclassified roughly 8,000 employees of the Department of Health and Human Services. The change moves them into a “Schedule F” category that removes many civi…
    STAT · 4mo agoRegulatoryNegative↗ source
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  • HHS Office of Human Research Protections faces staff shortages, jeopardizing participant safety oversight
    In 2021 the Office of Human Research Protections (OHRP) received a report of a participant suicide during a depression and mobility study at the New York State Psychiatric Institute. The incident p…
    STAT · 4mo agoRegulatoryNegative↗ source
  • ADA conference preview spotlights newer GLP-1 drugs, research funding cuts and a protest
    Elizabeth Cooney reports from the American Diabetes Association annual meeting in New Orleans, introducing the first of three STAT "ADA in 30 Seconds" newsletters. She notes the warm weather outsid…
    STAT · 4mo agoNeutral↗ source
  • US shifts Ebola treatment for exposed Americans to overseas facilities, sparking concerns over care access
    In an opinion piece, infectious‑disease physician Krutika Kuppalli reflects on her experience responding to the West Africa Ebola outbreak and the expectations that the United States would bring il…
    STAT · 4mo agoRegulatoryNegative↗ source
  • NIH senior adviser promotes MAHA strategy at ADA conference amid skeptical audience
    At the American Diabetes Association meeting in New Orleans, Richard Woychik, a senior adviser to NIH Director Jay Bhattacharya, opened his remarks by endorsing the Make America Healthy Again (MAHA…
    STAT · 4mo agoNeutral↗ source
  • RevMed’s experimental pancreatic cancer drug available via expanded access as FDA voucher program faces potential changes
    RevMed's experimental pancreatic cancer therapy daraxonrasib has not received FDA approval yet, but the company is offering it through an expanded access (compassionate use) program. Access to the…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Texas attorney general probes energy drink safety as federal research ethics office shrinks dramatically
    The Texas attorney general has opened an inquiry into the safety and marketing claims of popular energy drinks, seeking to determine whether they pose health risks or violate state consumer protect…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • FDA faces Roche blackmail claim, launches mifepristone safety study and reviews voucher program pause request
    Roche has publicly accused the United States of blackmail in a dispute that surfaced in recent FDA discussions. The company’s allegation adds tension to ongoing regulatory dialogues. The Food and…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Infinimmune appoints Srikanth Pendyala as new chief medical officer
    Infinimmune announced the addition of Srikanth Pendyala to its leadership team as chief medical officer. Pendyala comes to the role after serving in the same capacity at Stealth NewCo and Endeavor…
    STAT · 4mo agoPositive↗ source
  • Physician’s personal emergency highlights safety concerns in universal health care systems
    Nisha Narayanan, a clinical assistant professor of pediatrics who splits her practice between New York City and Edinburgh, reflects on how moving abroad reshaped her views on health care. Three we…
    STAT · 4mo agoNeutral↗ source
  • Supreme Court rules generic maker Hikma does not infringe Amarin patents, easing skinny-label lawsuits
    The U.S. Supreme Court issued a unanimous decision that Hikma Pharmaceuticals did not violate patents owned by Amarin. The high court overturned a lower court ruling that had favored the brand name…
    STAT · 4mo agoRegulatoryPositive↗ source
  • AI pioneer Jakob Uszkoreit’s Inceptive Nucleics teams with Alnylam as biotech lobby pushes Congress for DNA safeguards
    Jakob Uszkoreit, one of the architects behind the transformer model that powers ChatGPT, has turned his attention to drug development. His new venture, Inceptive Nucleics, is creating biological fo…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Grail’s Galleri multi-cancer early detection trial misses primary endpoint, but oncologists note promising signals
    The first randomized trial of a multi-cancer early detection test enrolled about 143,000 English adults aged 50 to 77. Participants were randomly assigned to receive either standard care or the Gal…
    STAT · 4mo agoNegative readoutNeutral↗ source
  • Promising pancreatic cancer drug daraxonrasib shows near-double survival, patients await expanded access
    Amy Johnston, diagnosed with pancreatic cancer last year, has undergone chemotherapy and surgery and is now in a clinical trial that hopes to delay disease progression. She expects results by the e…
    STAT · 4mo agoPositive readoutNeutral↗ source
  • Eli Lilly cuts German weight-loss syringe investment by half amid new cost-cutting law
    Eli Lilly said it will cut its planned investment in Germany for the production of weight‑loss syringes. The company had originally earmarked $2.67 billion, but will now invest roughly half that a…
    STAT · 4mo agoDealNegative↗ source
  • Revolution Medicines eyes broader use of daraxonrasib pending FDA submission
    Revolution Medicines' daraxonrasib has not yet been approved for metastatic pancreatic cancer after chemotherapy, but a recent ASCO plenary presentation generated strong interest. Analysts expect…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Lawmakers backtrack on promised Medicaid protections for cancer patients, new CMS rules impose work requirements
    Gwen Nichols, a hematologist/oncologist and chief medical officer of Blood Cancer United, wrote that lawmakers who pledged to protect cancer patients from Medicaid cuts are now backing a policy tha…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Patient-focused AI apps turn smartphones into real-time visit scribes
    More than a quarter of U.S. medical practices now rely on AI-powered ambient scribes that record appointments and draft clinical notes for doctors. The technology, initially deployed for clinicians…
    STAT · 4mo agoDealPositive↗ source
  • Trump admin moves to politicize NIH grant officials, stripping job protections
    The White House issued an executive order that reclassifies thousands of civil‑service positions as political appointments under the so‑called Schedule F. The change would allow the administration…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Drug makers and patient groups call on FDA to suspend fast‑track voucher program
    The FDA held a town‑hall listening session on its Commissioner’s National Priority Voucher program, hearing from 17 speakers that included patient advocates, pharmaceutical companies and academic r…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Otsuka's Voyxact reduces kidney function decline in IgA nephropathy but falls short of expectations in Phase 3
    Otsuka reported Phase 3 trial results for its drug Voyxact in patients with IgA nephropathy, a chronic autoimmune kidney disease. In the study, patients receiving Voyxact experienced an annualized…
    STAT · 4mo agoNegative readoutNeutral↗ source
  • Scientists identify previously unknown HIV reservoir in the body
    Scientists have reported the discovery of a new location where HIV can hide within the human body. The finding expands the list of known viral reservoirs and suggests that the virus may persist in…
    STAT · 4mo agoNeutral↗ source
  • Utah Medical Board Criticized for Unilateral Stance on AI in Healthcare
    The Utah Medical Board faced rebuke after it took an independent approach to criticizing artificial intelligence tools used in medical practice. The criticism came as the state was running a pilot…
    STAT · 4mo agoRegulatoryNegative↗ source
  • HHS says Americans with high-risk Ebola exposure can receive experimental antibody MBP-134 from Mapp Biopharma
    HHS announced that U.S. citizens who have had high-risk exposure to Ebola in the ongoing Central African outbreak will be eligible to receive an experimental antibody therapy. The treatment, ident…
    STAT · 4mo agoRegulatoryPositive↗ source