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  • Encoded Therapeutics secures $275M Series F to push Dravet gene therapy and expand manufacturing
    Encoded Therapeutics, a biotech focused on neuro‑genetic disorders, announced a $275 million Series F financing round. The capital was co‑led by Google Ventures and an undisclosed healthcare fund,…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Tyra Biosciences reports phase 2 bladder cancer data, complete response rates miss analyst targets, shares slide
    Tyra Biosciences disclosed early phase 2 results for its FGFR3‑selective inhibitor dabogratinib in patients with low‑grade, intermediate‑risk non‑muscle‑invasive bladder cancer. The trial evaluate…
    Fierce Biotech · 2mo agoNegative readoutNegative
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  • Abbott receives FDA clearance for TactiFlex Duo catheter, offering flexible AFib ablation options
    Abbott announced that the U.S. Food and Drug Administration has cleared its new TactiFlex Duo catheter for use in atrial fibrillation ablation. The catheter can deliver pulsed field ablation, radi…
    Fierce Biotech · 2mo agoRegulatoryPositive↗ source
  • Beeline's oral lupus drug afimetoran meets primary endpoint in Phase 2, paving way for Phase 3
    Beeline Medicines announced that its oral small-molecule inhibitor afimetoran achieved the primary endpoint in a 48-week Phase 2 trial in patients with systemic lupus erythematosus (SLE). The tria…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source
  • UK commission proposes new framework to regulate AI-driven medical tools
    A UK commission released a report on Thursday outlining 44 recommendations for how artificial intelligence should be governed in the medical sector. The guidance aims to capture AI's promise, such…
    STAT · 2mo agoRegulatoryNeutral↗ source
  • Gilead says its oncology and inflammation portfolio has reached critical mass after series of acquisitions
    Gilead Sciences CEO Daniel O’Day told Fierce that the company’s push into oncology and inflammation has now reached a point of critical mass, with a pipeline that spans early research to late‑stage…
    Fierce Biotech · 2mo agoPositive↗ source
  • Webinar explores how GLP-1 obesity drugs are reshaping US healthcare and market dynamics
    The upcoming webinar titled "The Massive Scale of GLP-1s: Evolving Health, Healthcare and Markets" will examine how GLP-1 receptor agonists used for obesity are altering the U.S. health-care landsc…
    BioSpace · 2mo agoNeutral↗ source
  • nPhase unveils AI-driven clinical data platform to accelerate trial design and submission
    nPhase, a clinical research organization, announced the launch of an end-to-end platform called nPhase.ai that uses artificial intelligence to manage clinical trial data. The platform includes a S…
    Fierce Biotech · 2mo agoPositive↗ source
  • BMS reports positive mid-stage results for arlo-cel in heavily pre-treated myeloma patients
    BMS said its CAR T therapy arlo-cel, formally arlocabtagene autoleucel, achieved positive results in a registrational mid-stage study for relapsed and refractory multiple myeloma. The open-label,…
    BioSpace · 2mo agoPositive readoutPositive↗ source
  • Caspian Therapeutics launches with $50M to develop menin inhibitors for diabetes and cardiometabolic disease
    Caspian Therapeutics, a spin‑out from Kura Oncology, announced it is starting operations with $50 million in financing. The capital, led by BVF Partners and joined by Eli Lilly and Kura leadership,…
    STAT · 2mo agoDealPositive↗ source
  • Caspian Therapeutics launches with $50M funding and Eli Lilly backing to develop menin inhibitor for diabetes
    Caspian Therapeutics has been created as a spin-out from Kura Oncology to advance a menin-targeting drug for diabetes. The company received $50 million in initial capital, led by BVF Partners with…
    BioSpace · 2mo agoDealPositive↗ source
  • Kura Oncology launches Caspian Therapeutics with $50M funding to develop next-generation diabetes drug
    Kura Oncology has created a new biotech called Caspian Therapeutics and secured $50 million in financing to advance a next-generation diabetes treatment. The spinout will focus on KO-7246, a highl…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • AMA chief says AI will augment, not replace, physicians
    John Whyte, the chief executive of the American Medical Association, wrote an opinion piece asserting that artificial intelligence should work alongside doctors rather than take their place. He po…
    STAT · 2mo agoPositive↗ source
  • Opinion: Autonomous AI could surpass AI-assisted doctors on key tasks by 2030
    The piece, authored by Ezekiel J. Emanuel and Abe Baker-Butler, argues that autonomous artificial intelligence is likely to outpace both unaided physicians and those using AI assistance on five cor…
    STAT · 2mo agoNeutral↗ source
  • Biopharma looks beyond China to five alternative overseas markets amid rising geopolitical tensions
    Geopolitical tensions between the United States and China are prompting biopharma companies to look beyond the Chinese market for growth. China remains the leading destination, with licensing deal…
    BioSpace · 2mo agoNeutral↗ source
  • Biotech crossover rounds projected to exceed $4.2 billion in 2026, supporting IPO pipeline
    PitchBook forecasts that biotech crossover rounds could surpass $4.22 billion across roughly 28 rounds in 2026. The surge follows a market bottom after COVID and a rise in investor confidence, wit…
    BioSpace · 2mo agoDealPositive↗ source
  • Labcorp acquires MLM Medical Labs to expand global lab network across four continents
    Labcorp, a major medtech and testing company, announced it has completed the acquisition of MLM Medical Labs. MLM operates central and specialty labs in the United States, Germany, and South Afric…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Solstice Oncology raises $225M Series A to push next-gen CTLA-4 antibody into Phase 2 colon cancer trial
    Solstice Oncology announced a $225 million Series A financing led by RA Capital Management, with participation from Canaan Partners and Forbion. The capital will fund the Phase 2 study of its Fc-e…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • FDA appoints permanent heads of drug, biologics and tobacco centers and adds AI deputy commissioner
    The U.S. Food and Drug Administration announced permanent appointments for the leaders of its major product centers. The Center for Drug Evaluation and Research and the Center for Biologics Evalua…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Massachusetts governor warns early-stage biotech firms of capital crunch ahead of election
    Massachusetts Governor Maura Healey visited the MassBio headquarters in Cambridge, meeting with roughly 50 CEOs of early-stage biotech companies. The gathering, held on a Wednesday afternoon, was i…
    Fierce Biotech · 2mo agoNegative↗ source
  • Telemedicine firm begins offering GLP-1 medications to treat addiction
    A telemedicine company announced it will now prescribe GLP-1 class drugs to patients with substance-use disorders through its virtual platform. GLP-1 medications, originally approved for diabetes…
    STAT · 2mo agoNeutral↗ source
  • Advancing New Approach Methodologies: Building Standards and Evidence to Boost Preclinical Adoption
    New Approach Methodologies (NAMs) are being hailed as a way to transform preclinical research and toxicology, but their wider use has been hampered by three key barriers: sourcing appropriate cells…
    Fierce Biotech · 2mo agoPositive↗ source
  • FDA appoints permanent heads for CDER and CBER amid pending commissioner confirmation
    The Department of Health and Human Services announced that Michael Davis, MD, PhD, and Karim Mikhail will become the permanent directors of the Centers for Drugs Evaluation and Research and the Cen…
    Fierce Biotech · 2mo agoRegulatoryNeutral↗ source
  • AI tools struggle to improve emergency room workflow, study finds
    The article notes that CEOs of leading AI firms have promised dramatic health benefits, but real‑world testing in emergency departments tells a different story. At Brigham and Women’s Hospital, th…
    STAT · 2mo agoNegative↗ source
  • Two infants die in Pennsylvania measles outbreak, coroner confirms one death caused by virus
    Pennsylvania’s health coroner released details about two infant deaths that occurred during a growing measles outbreak in the state. The first infant, Ivan Miller, died on Aug. 14 shortly after bi…
    STAT · 2mo agoNegative↗ source