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  • EMA issues guidance to curb microbial contamination in non-sterile medicines; MHRA reports record drug approvals
    The European Medicines Agency has issued new guidance that outlines technical and organisational measures to reduce the risk of microbial contamination in non-sterile pharmaceutical products. The…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Cue Biopharma appoints Dominic Borie as chief medical officer and head of R&D
    Cue Biopharma announced the hiring of Dr. Dominic Borie, MD, PhD, as its new chief medical officer and head of research and development. Borie joins from Kyverna Therapeutics, where he served as a…
    Fierce Biotech · 3mo agoPositive↗ source
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  • Senate health committee hears testimony from Trump pandemic preparedness nominee amid daylight-saving debate
    The Senate health committee convened a hearing where the president’s pandemic preparedness nominee provided testimony on readiness measures. Lawmakers also debated proposals to make daylight savin…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • UK regulator reports rise in drug approvals and steps toward AI oversight in healthcare
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines this year than in t…
    raps · 3mo agoRegulatoryNeutral↗ source
  • ADA blocks Diabetes Care editorial on conference controversy, sparking fresh turmoil
    Turmoil at the American Diabetes Association (ADA) has intensified after leaders prevented editors of its flagship journal, Diabetes Care, from publishing an editorial and first-person accounts abo…
    STAT · 3mo agoNegative↗ source
  • Defense Secretary proposes annual testosterone screening for service members, sparking mixed expert reaction
    U.S. Defense Secretary Pete Hegseth announced that service members will have testosterone deficiency testing added to their annual physical exams. The plan targets war-fighters aged 30 and older, w…
    STAT · 3mo agoNeutral↗ source
  • Kelun-Biotech reports first-line success of Merck-partnered ADC sacituzumab tirumotecan in China
    Kelun-Biotech announced that its antibody‑drug conjugate sacituzumab tirumotecan, developed in partnership with Merck, achieved its primary efficacy endpoints when used as a first‑line therapy in a…
    Endpoints · 3mo agoPositive readoutNeutral↗ source
  • Uganda remains silent on Marburg outbreak updates, WHO says
    The World Health Organization noted that Uganda has not provided any new information since it announced a Marburg virus outbreak late last month. WHO officials have sent multiple requests for deta…
    STAT · 3mo agoNeutral↗ source
  • ‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D wins
    A string of recent wins on the frontiers of novel drug development could mean that a homegrown innovation industry is within reach.
    Fierce Biotech · 3mo agoNeutral↗ source
  • Reporter attends AHA Leadership Summit in Denver to gauge hospital executives' priorities
    The author attended the American Hospital Association’s Leadership Summit in downtown Denver earlier this week. While there, the author handed out ice cream recommendations to attendees. The prim…
    Endpoints · 3mo agoNeutral↗ source
  • Merck-Kelun ADC sac-TMT shows progression-free survival benefit with Keytruda in late-stage NSCLC trial
    Kelun-Biotech announced that its antibody‑drug conjugate sac‑TMT, developed with Merck, achieved positive Phase 3 results when paired with Keytruda in a non‑small cell lung cancer trial. The data…
    BioSpace · 3mo agoPositive readoutPositive↗ source
  • Celcuity’s breast cancer therapy gets FDA approval as new CBER chief outlines biotech priorities
    Celcuity announced that its first breast cancer drug has been approved by the U.S. Food and Drug Administration, marking the company’s initial market entry in oncology. The announcement coincided…
    STAT · 3mo agoApprovalPositive↗ source
  • J&J restructures pharma supply chain, offloading sites as part of $55 B U.S. manufacturing push
    Johnson & Johnson announced it is restructuring its pharmaceutical supply chain, offloading certain sites to streamline operations as part of its $55 billion U.S. manufacturing initiative. The cha…
    BioSpace · 3mo agoPositive↗ source
  • Medicare proposes ban on vendor-provided remote patient monitoring services
    Medicare regulators have proposed a rule that would prohibit vendors from delivering remote patient monitoring services on behalf of physicians, marking a significant policy shift. Remote patient…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Senator Lindsey Graham’s death highlights gaps in detecting aortic dissection
    Senator Lindsey Graham, 71, died on Saturday after suffering an aortic dissection, a sudden tear in the body's main blood vessel that can be fatal. A final death certificate has not yet been relea…
    STAT · 3mo agoNegative↗ source
  • Senate hearing probes CDC nominee Erica Schwartz amid concerns over political pressure from RFK Jr. and Trump
    Senate leaders questioned Erica Schwartz, the administration's nominee to head the CDC, about her ability to resist political pressure during a Wednesday hearing. Lawmakers referenced the earlier…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • FDA acting chief says two journal articles by former commissioner do not represent agency policy
    Acting FDA Commissioner Kyle Diamantas announced that the agency is reversing its earlier position regarding two medical‑journal articles authored by former commissioner Marty Makary. The FDA now…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • New blood-based Alzheimer’s tests promise easier, more detailed diagnosis
    At the recent Alzheimer’s Association International Conference, researchers presented advances that could make Alzheimer’s testing more widely available and informative. Current diagnostic methods…
    STAT · 3mo agoPositive↗ source
  • Senator Cassidy challenges Trump pandemic nominee over anti-vaccine LinkedIn post
    Senate Health Committee Chairman Bill Cassidy confronted Sean Kaufman, President Trump's nominee for a senior pandemic preparedness position, during the confirmation hearing. Cassidy cited a delet…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Johnson & Johnson to spend up to $750 million restructuring pharma manufacturing and closing plants
    Johnson & Johnson announced it will incur up to $750 million as it reshapes its pharmaceutical manufacturing network. The plan involves exiting certain factories and consolidating production, aimi…
    Endpoints · 3mo agoNeutral↗ source
  • Glenmark agrees to $29.6 million settlement over generic drug price-fixing claims
    Glenmark Pharmaceuticals has reached a settlement with dozens of U.S. states, agreeing to pay $29.6 million to resolve accusations that it participated in a scheme to inflate prices of generic medi…
    STAT · 3mo agoDealNegative↗ source
  • Nobel laureate Jennifer Doudna unveils AI-driven platform to design novel gene‑editing enzymes
    Jennifer Doudna, the Nobel laureate who co‑invented CRISPR, announced a new AI‑powered platform for creating gene‑editing proteins in a paper published today in Science. The system uses computation…
    Fierce Biotech · 3mo agoPositive↗ source
  • Lonza urges biotech firms to prioritize early de-risking to streamline IND path
    In a recent interview, Jaime Okray of Lonza highlighted that emerging biotech companies are shifting focus from pure speed to early identification of development risks as they aim for an IND filing…
    Fierce Biotech · 3mo agoPositive↗ source
  • AdvanCell secures $315M Series D to advance lead-based prostate cancer therapy
    AdvanCell announced a $315 million Series D financing round aimed at supporting development of its lead-based prostate cancer agent and expanding U.S. manufacturing capacity for the radioactive tre…
    Endpoints · 3mo agoDealPositive↗ source
  • Agentic AI poised to reshape clinical development by moving beyond tools to autonomous decision-making
    Earlier this year, a colleague argued that clinical leaders should stop asking whether they have an 'AI strategy', because the question often leads to the wrong conversation. Instead, leaders are…
    Fierce Biotech · 3mo agoPositive↗ source