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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 · 5mo agoRegulatoryNegative↗ source
  • Biotech lobby groups in Washington push to keep Chinese low-cost drug pipeline open amid rising anti-China proposals
    Washington biotech lobby groups are working to ensure a steady flow of affordable medicines that originate from Chinese manufacturers. These groups have become aware that they are encountering voc…
    Endpoints · 5mo agoRegulatoryNeutral↗ source
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  • Industry and rare disease groups call for more transparency in FDA voucher pilot
    The pharmaceutical industry and rare‑disease advocacy groups have voiced concerns about the Commissioner's National Priority Voucher pilot program. Stakeholders say the program lacks transparency…
    Endpoints · 5mo 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 · 5mo agoNeutral↗ source
  • House Appropriations Committee urges FDA to accelerate IND approvals for clinical trials
    The House Appropriations Committee issued a directive to the Food and Drug Administration, calling for reforms to speed up the Investigational New Drug (IND) sign-off process for new clinical trial…
    Endpoints · 5mo agoRegulatoryNeutral↗ 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo 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 · 5mo agoRegulatoryNeutral↗ source
  • Uli Stilz joins Flagship while Revolution Medicines adds Alex Hoffman as commercial lead
    On June 5, 2026, biotech veteran Uli Stilz announced his new position at Flagship, marking a notable personnel shift in the industry. Stilz has spent much of the year traveling internationally, in…
    Endpoints · 5mo agoNeutral↗ 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 · 5mo 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 · 5mo agoNeutral↗ source
  • Novo Nordisk Indiana plant faces FDA re-inspection after hair found in drugs and roof leaks threaten sterility
    Novo Nordisk's fill‑finish facility in Bloomington, Indiana underwent a follow‑up FDA inspection in April. The agency reported mammalian hair in finished drug containers and identified water leaks…
    Endpoints · 5mo agoRegulatoryNegative↗ source
  • Otsuka presents new data to bolster full approval bid for Voyxact in IgA nephropathy
    Otsuka Pharmaceutical announced that new clinical evidence has been generated for its monoclonal antibody Voyxact, aimed at treating IgA nephropathy, a chronic autoimmune kidney disease. The data,…
    Endpoints · 5mo agoRegulatoryPositive↗ 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 · 5mo agoRegulatoryPositive↗ source
  • Dimension Capital targets up to $750M for third life-sciences fund after strong portfolio performance
    Dimension Capital, a New York and San Francisco-based investment firm that blends machine learning with life-science ventures, announced it is launching its third fund. The firm is seeking up to $…
    Endpoints · 5mo agoDealPositive↗ source
  • FDA reinspects Novo Nordisk's Indiana plant, finds mammalian hair and roof leaks compromising drug sterility
    Novo Nordisk's manufacturing facility in Indiana, acquired from Catalent, has undergone a second FDA reinspection after earlier concerns. The April inspection revealed mammalian hair in finished d…
    Endpoints · 5mo agoRegulatoryNegative↗ source
  • Hikma invests $267 million in Ohio as Cingulate receives CRL for ADHD candidate
    Hikma Pharmaceuticals, a generic drugmaker, announced a $267 million investment to expand its manufacturing footprint in Ohio. The plan includes $216 million to upgrade its existing Columbus plant…
    Endpoints · 5mo agoDealNeutral↗ source
  • Novo Holdings invests €500 million in Europe-focused fund as Alnylam advances second obesity drug to clinic
    Novo Holdings, the investment arm of the Novo Nordisk Foundation, has committed €500 million to the Scaleup Europe Fund, a vehicle aimed at supporting European biotech scale‑ups. Alnylam Pharmaceu…
    Endpoints · 5mo agoDealPositive↗ 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 · 5mo 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 · 5mo 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 · 5mo agoPositive readoutNeutral↗ source
  • Lilly and Boehringer cut German investments amid health-spending overhaul
    A proposed overhaul of Germany's health-insurance financing is sparking criticism from industry groups. Eli Lilly and Boehringer Ingelheim announced they will reduce their investment programmes in…
    Endpoints · 5mo agoRegulatoryNegative↗ source
  • Supreme Court unanimously backs Hikma's skinny label fish oil generic
    The U.S. Supreme Court issued a unanimous decision favoring Hikma Pharmaceuticals in a dispute over its skinny label version of a prescription-strength fish oil product. The court ruled that Hikma…
    Endpoints · 5mo agoRegulatoryPositive↗ source