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  • Lundbeck advances PACAP-targeting migraine drug after mid-stage trial shows reduction in migraine days
    Lundbeck reported new data from a mid-stage study of its experimental migraine prevention therapy, bocunebart, which targets the PACAP protein involved in headache pathways. The trial enrolled hun…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • 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 · 3mo agoNegative↗ source
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  • 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 · 3mo agoRegulatoryNegative↗ source
  • Supreme Court rules generic Vascepa copy does not infringe patents, boosting skinny-label pathway
    The U.S. Supreme Court issued a decision that Hikma Pharmaceuticals’ generic version of Amarin’s heart drug Vascepa does not infringe the brand’s patents. The ruling clarified that the generic make…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
  • Analysts warn that PD-1/VEGF bispecific drugs may be better suited for liver cancer than lung cancer
    Many drugmakers have poured billions into PD-1/VEGF bispecific antibodies after ivonescimab beat Keytruda in a 2024 lung‑cancer trial, sparking a wave of deals and development programs. A recent C…
    BioPharma Dive · 3mo agoNeutral↗ source
  • 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoNeutral↗ source
  • ADC Therapeutics shares plunge as Phase 3 trial of Zynlonta shows high death rate despite efficacy gain
    ADC Therapeutics reported Phase 3 data for Zynlonta combined with rituximab in a hard-to-treat blood cancer. The trial met its primary endpoint by extending progression-free survival versus standar…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ 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 · 3mo agoRegulatoryPositive↗ source
  • Alnylam partners with Inceptive Nucleics on AI deal that could reach $2 billion
    Alnylam Pharmaceuticals announced a partnership with Inceptive Nucleics to apply artificial‑intelligence tools to its RNA‑based drug discovery program. The agreement provides an upfront $30 millio…
    BioPharma Dive · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo 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 · 3mo agoDealPositive↗ source
  • Spanish biotech Ona Therapeutics secures $86.6 million Series B to advance new ADCs for breast and colorectal cancer
    Ona Therapeutics, a Barcelona‑based biotechnology startup, announced a Series B financing round that raised roughly $86.6 million. The new capital will fund the launch of two antibody‑drug conjuga…
    BioPharma Dive · 3mo agoDealPositive↗ source