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  • FDA advisory panel advises against approving Capricor’s Duchenne cell therapy, deramiocel
    The FDA Cellular, Tissue, and Gene Therapies Advisory Committee convened to evaluate deramiocel, a cell‑based treatment for Duchenne muscular dystrophy developed by Capricor Therapeutics. Capricor…
    STAT · 3d agoRegulatoryNegative↗ source
  • Caldera Therapeutics completes reverse merger with Synlogic, secures $278 million financing
    Caldera Therapeutics, a Massachusetts biotech founded last year, announced a reverse merger with Nasdaq-listed Synlogic, giving it a public listing. The transaction includes a $278 million financi…
    Fierce Biotech · 3d agoDealPositive↗ source
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  • Former VA Secretary argues the Veterans Health Administration can boost US biotech competitiveness against China
    The piece, authored by former Veterans Affairs Secretary David Shulkin, positions the VA as a critical component of America’s biotechnology ecosystem alongside HHS and the Department of Defense. H…
    STAT · 3d agoNeutral↗ source
  • Study finds clinical chatbots lag behind general AI models in accuracy, sparking debate among doctors
    Hundreds of thousands of U.S. physicians are using clinical large language model tools marketed by firms such as OpenEvidence, Doximity and UpToDate as safer alternatives to generic AI chatbots. A…
    STAT · 3d agoNegative readoutNegative↗ source
  • FTC sues Hims & Hers for misleading consumers and privacy violations
    The Federal Trade Commission, joined by Utah and California, filed a lawsuit against Hims & Hers, a direct-to-consumer telehealth provider, alleging deceptive business practices. The complaint say…
    STAT · 2d agoRegulatoryNegative↗ source
  • Fugitive Discovered Working Under Alias in Biotech Industry Amid Legal Battles Involving AstraZeneca and Lilly
    A Rhode Island fugitive who had been on the most-wanted list was recently uncovered as having worked under a false identity in the biotech sector. The revelation raised questions about how the ind…
    STAT · 2d agoNegative↗ source
  • Nanoparticle-loaded chemotherapy crosses blood-brain barrier in mice after glioblastoma surgery, study shows
    Researchers at the University of Manchester have demonstrated that a standard chemotherapy drug can reach the brain when packaged in liposome nanoparticles and given shortly after tumor removal in…
    Fierce Biotech · 3d agoPositive↗ source
  • Biogen CEO says company will pause new acquisitions and focus on developing existing pipeline
    Biogen's chief executive Christopher Viehbacher told analysts during the second-quarter earnings call that the company will slow its merger and acquisition activity for the foreseeable future. Aft…
    Fierce Biotech · 3d agoDealNeutral↗ source
  • Vertex pays $28 million upfront to AbCellera for autoimmune T-cell engager collaboration
    Vertex Pharmaceuticals has entered a collaboration with AbCellera, paying an upfront sum of $28 million to access the latter’s T-cell engager platform for autoimmune disease programs. Under the ag…
    Fierce Biotech · 3d agoDealNeutral↗ source
  • NSF launches $47 million pilot to create joint university-industry Ph.D. programs for life scientists
    The National Science Foundation, with funding announced by the Trump administration, is testing a new Ph.D. training model that blends academic study with industry experience. The $47 million pilo…
    STAT · 2d agoPositive↗ source
  • Merck briefly lists, then removes, phase 2 trial of PD-1xVEGF bispecific with TROP2 ADC
    Merck & Co. posted a clinical trial listing for a phase‑2 study combining its PD‑1xVEGF bispecific antibody (MK‑2010) with the TROP2‑directed antibody‑drug conjugate sac‑TMT. The listing, shown as…
    Fierce Biotech · 2d agoNeutral↗ source
  • Prolonged hospital stays leave children isolated, urging change
    An author visiting a pediatric ward describes a young, nonverbal child with severe developmental delays who has been waiting months for a life-saving liver transplant. The child lies in a stark, ma…
    STAT · 3d agoNegative↗ source
  • 529 Commerce recalls Rooted in Rare Aquafaba Powder over possible undeclared egg allergen
    529 Commerce, LLC of Parkland, Florida announced a recall of its Rooted in Rare brand Aquafaba Powder. The recall includes 3,860 units packaged in 4‑oz and 12‑oz flexible foil pouches that were so…
    fda recalls · 3d agoRegulatoryNegative↗ source
  • Most-wanted fugitive Ronald Fischer operated under alias in biotech industry for two decades
    A Rhode Island man on the most-wanted list was recently uncovered as a hidden employee in the biotech sector, having worked under a false identity for about twenty years. The individual, identifie…
    STAT · 3d agoNegative↗ source
  • 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 · 3d agoNeutral↗ source
  • Publix recalls all GreenWise Organic frozen blueberries and mixed berries over potential E. coli O145 contamination
    Publix announced a recall of all lots of GreenWise Organic Whole Blueberries and Whole Mixed Berries because the products may be contaminated with Escherichia coli O145:H28. The strain is a Shiga…
    fda recalls · 3d agoCRLNegative↗ 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
  • 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
  • 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 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
  • 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