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  • Fauci invokes Fifth Amendment, declines to answer Covid-19 origins questions at Senate hearing
    At a Senate hearing on Wednesday, former U.S. health chief Anthony Fauci invoked his Fifth Amendment right and refused to answer lawmakers' questions about the Covid-19 pandemic and its origins. F…
    STAT · 2d agoRegulatoryNeutral↗ source
  • Morning Rounds flags overlooked pedestrian and cyclist deaths, upcoming Fauci Senate hearing, and research visa limits
    The latest Morning Rounds newsletter draws attention to the often‑ignored problem of deaths among pedestrians and cyclists, urging greater public health focus. It also notes that Dr. Anthony Fauci…
    STAT · 2d agoNeutral↗ source
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  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 3d agoLayoffsNegative↗ source
  • Atea’s hepatitis C combo matches Gilead’s Epclusa in phase 3 trial
    Boston-based biotech Atea Pharmaceuticals reported that its once-daily hepatitis C combination of bemnifosbuvir and ruzasvir performed on par with Gilead's Epclusa in a pivotal phase 3 study. The…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • FDA finds Capricor's Duchenne stem cell therapy failed to meet Phase 3 goals, contradicting company claims
    The U.S. Food and Drug Administration announced that the stem cell treatment from Capricor Therapeutics did not achieve the primary objectives in its Phase 3 trial for Duchenne muscular dystrophy.…
    STAT · 3d agoRegulatoryNegative↗ source
  • FDA finds Replimune's melanoma data package uninterpretable, foreshadows tough advisory committee review
    The FDA has deemed the single-arm mid-stage study submitted by Replimune for its oncolytic immunotherapy RP1 as not interpretable, raising concerns ahead of an upcoming advisory committee meeting.…
    BioSpace · 3d agoRegulatoryNegative↗ source
  • Eli Lilly climbs to top of Norstella’s Pipeline-to-Patient Productivity Index, beating 24 peers
    Eli Lilly has risen to the top of Norstella’s inaugural Pipeline-to-Patient Productivity Index, a new benchmark that rates large global biopharma firms on research productivity, market access and c…
    Fierce Biotech · 3d agoPositive↗ source
  • Claris Bio raises $118M Series B and appoints new CEO to advance eye-drug for limbal stem cell deficiency
    Claris Bio, a New Jersey biotechnology company, announced a $118 million Series B financing round co-led by Samsara BioCapital and Catalio Capital Management, with participation from Sofinnova Inve…
    BioPharma Dive · 3d agoDealPositive↗ source
  • Apnimed targets up to $160 million IPO to fund sleep‑apnea drug AD109
    Apnimed, a sleep‑specialist biotech, announced plans for an initial public offering that could raise up to $160 million in gross proceeds. The company will sell 10 million shares at $14‑$16 each,…
    BioSpace · 4d agoDealPositive↗ source
  • Altimmune’s pemvidutide cuts heavy drinking days in phase 2 AUD trial
    Altimmune announced that its experimental dual GLP-1/glucagon receptor agonist pemvidutide reduced heavy drinking in a phase‑2 study of alcohol use disorder. In the 24‑week Reclaim trial, particip…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • GSK announces $2.5 billion annual cost-cutting plan to offset upcoming patent cliff
    GSK disclosed in its latest quarterly earnings that it will launch a three-year restructuring aimed at saving about £1.9 billion ($2.5 billion) each year. The plan is intended to cushion the impac…
    BioPharma Dive · 3d agoLayoffsNeutral↗ source
  • GSK launches $2.5 billion restructuring plan to fund late-stage pipeline and offset upcoming HIV drug patent loss
    GSK reported $2.4 billion in impairment charges for the second quarter and unveiled a three‑year restructuring designed to save roughly $2.5 billion. The company says the savings will be redirecte…
    BioSpace · 3d agoPositive↗ source
  • GSK CEO outlines £1.9bn cost-saving drive and aims to launch 20 Phase 3 trials by year-end
    GSK chief executive Luke Miels presented a three‑year plan to make the company more agile and generate significant cost efficiencies. The strategy targets £1.9 billion in annual savings by 2029, wi…
    STAT · 3d agoPositive↗ source
  • FDA staff raise concerns over Replimune's skin cancer drug data
    FDA staff have reiterated concerns that Replimune's investigational skin cancer therapy lacks sufficient data for approval. The agency highlighted the single-arm trial, in which patients previousl…
    STAT · 3d agoRegulatoryNegative↗ source
  • Altimmune's pemvidutide cuts heavy drinking days in Phase 2 trial
    Altimmune reported that its experimental GLP-1/GIP injection pemvidutide achieved its primary and key secondary goals in a Phase 2 study of alcohol use disorder. The double-blind trial enrolled 10…
    BioSpace · 3d agoPositive readoutPositive↗ source
  • FDA’s AI push faces uncertainty after key leaders depart
    The FDA has been pushing artificial intelligence across the agency, unveiling a large-language-model tool called Elsa to help draft and summarize review reports and announcing plans to use agentic…
    BioPharma Dive · 3d agoRegulatoryNeutral↗ source
  • Oak Hill Bio to go public via SPAC merger, securing $175 million for Angelman syndrome program
    Oak Hill Bio announced it will become a publicly traded company through a merger with the special purpose acquisition company Research Alliance Corporation III. The transaction will provide $75 mi…
    BioSpace · 4d agoDealPositive↗ source
  • ProMIS Neurosciences early trial shows low brain bleeding and no swelling, hinting at safer Alzheimer’s drug
    ProMIS Neurosciences reported interim safety data from a early‑stage trial of its amyloid‑targeting therapy for Alzheimer’s disease. The analysis pooled data from participants receiving the investi…
    STAT · 4d agoPositive readoutPositive↗ source
  • GSK launches three-year £1.9bn savings plan to boost late-stage R&D and relocate research HQ
    GSK announced a three-year cost-saving programme designed to free cash for its late-stage research and development pipeline while moving its research headquarters. The plan targets annual savings…
    Fierce Biotech · 4d agoNeutral↗ source
  • Dementia finally shows a viable business model, AAIC2026 highlights economic shift
    At the Alzheimer’s Association International Conference in London this year, the author observed that dementia now appears to have a clear business model, a shift from earlier meetings where commer…
    STAT · 4d agoPositive↗ source
  • Boston Scientific unveils major restructuring, plots job cuts amid savings drive
    Medical device maker Boston Scientific has been a prolific dealmaker this year but is now taking a step back as it looks to make changes internally.
    Fierce Biotech · 4d agoLayoffsNegative↗ source
  • Trump administration proposes four-year visa cap for foreign PhD students and postdocs, sparking science community concerns
    The Department of Homeland Security announced a new rule that limits the stay of international graduate students and postdoctoral researchers in the United States to four years on nonimmigrant visa…
    STAT · 3d agoRegulatoryNegative↗ source
  • As pharma descends on China for deals, BIOSECURE Act raises intellectual property risk
    When signing a biotech licensing deal in China, experts say that pharma’s patent attorneys need to understand the geopolitical risk of the BIOSECURE Act.
    BioSpace · 4d agoDealNeutral↗ source
  • Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection
    Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…
    raps · 4d agoRegulatoryNeutral↗ source
  • FDA draft guidance seeks clearer, more flexible QSP dose selection for first-in-human trials
    Industry groups have asked the FDA for more clarity in a draft guidance that outlines how sponsors can use quantitative systems pharmacology (QSP) to select doses for first-in-human studies. The r…
    raps · 4d agoRegulatoryNeutral↗ source