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  • Iambic Therapeutics raises $150 million in IPO to fund oncology drug development
    Iambic Therapeutics, a San Diego-based AI biotech, completed an initial public offering that raised $150 million, exactly meeting its goal of selling 9.4 million shares at $16 each. The company sa…
    Fierce Biotech · 27d agoDealPositive↗ source
  • Experts call for dedicated regulatory framework for clinical AI models, UK MHRA unveils AI-focused strategy
    Former FDA commissioner Scott Gottlieb, now at the American Enterprise Institute, wrote an opinion piece urging Congress to create a specific regulatory framework for artificial intelligence models…
    raps · 27d agoRegulatoryPositive↗ source
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  • EMA to cement ACT EU pilot; MHRA unveils AI-era regulatory strategy
    The European Medicines Agency announced that in January 2027 it will make permanent a pilot project that assists sponsors in preparing clinical trial applications, turning a temporary scheme into a…
    raps · 27d agoRegulatoryNeutral↗ source
  • IQVIA urges early clinical insight in drug discovery to boost patient benefit
    IQVIA Laboratories' leaders argue that drug discovery and clinical development should be linked early to improve patient outcomes. They explain that decisions made during discovery affect later cl…
    Fierce Biotech · 26d agoPositive↗ source
  • OrbiMed raises $3 billion, its biggest Asian fund yet, to boost biotech investments worldwide
    OrbiMed announced it has closed a $3 billion fundraising round, the largest ever for its Asia‑focused vehicle. The capital will be used to make new growth‑equity and venture investments in biotech…
    Fierce Biotech · 27d agoDealPositive↗ source
  • FDA issues early alert on Edwards Lifesciences transcatheter mitral valve delivery system after balloon burst reports
    The FDA's Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with certain Edwards Lifesciences delivery systems used in the SAPIEN M3 transcatheter m…
    fda medwatch · 27d agoRegulatoryNegative↗ source
  • SimBioSys receives FDA clearance for Nvidia-powered AI tool to predict breast cancer recurrence
    SimBioSys announced FDA clearance for its TumorSight Risk platform, an AI-driven tool that uses MRI, pathology and clinical data to assess the likelihood of breast cancer returning. The cloud-base…
    Fierce Biotech · 27d agoRegulatoryPositive↗ source
  • FDA issues warning letters to manufacturers over CGMP and GLP violations
    The U.S. Food and Drug Administration has sent warning letters to multiple drug manufacturers for failing to meet current good manufacturing practice requirements. The agency highlighted problems e…
    raps · 27d agoRegulatoryNegative↗ source
  • Osivax’s flu vaccine OVX836 misses primary efficacy goal in phase 2b trial
    Osivax announced that its influenza A vaccine candidate OVX836 failed to meet the primary efficacy endpoint in a phase 2b trial involving 2,850 healthy adults in Europe. The trial showed a vaccine…
    Fierce Biotech · 27d agoNegative readoutNegative↗ source
  • Experts call for Congress to create a dedicated regulatory framework for AI models used in academic medical centers
    On Oct. 15, 2026, several health policy experts voiced support for a new regulatory approach specifically aimed at clinical artificial‑intelligence models that are developed and deployed in academi…
    raps · 27d agoRegulatoryNeutral↗ source
  • Bausch + Lomb CEO Brent Saunders exits again, interim CEO Thomas Appio appointed
    Bausch + Lomb announced that CEO Brent Saunders is leaving the eye health company for a second time, less than four years into his latest tenure. The departure was mutually agreed upon by Saunders…
    Fierce Biotech · 26d agoNeutral↗ source
  • Lakefront Biotherapeutics sells its cell therapy pipeline to Belgian biotech Armed Cell Therapeutics
    Lakefront Biotherapeutics, formerly known as Galapagos Therapeutics, announced that it has sold its cell therapy pipeline to fellow Belgian biotech Armed Cell Therapeutics. The transferred assets…
    Fierce Biotech · 27d agoDealNeutral↗ source
  • FDA launches rare disease framework initiative
    A new initiative from the US Food and Drug Administration (FDA) aims to develop “an optimized, fit-for-purpose” framework to facilitate the development and marketing of treatments for rare diseases…
    raps · 27d ago↗ source
  • Verastem reports promising early results for KRAS G12D inhibitor in pancreatic and lung cancers
    Verastem Oncology has shifted its research toward a KRAS G12D inhibitor, VS-7375, and released early data from a phase 1/2 study involving more than 200 patients with advanced KRAS G12D-mutated sol…
    Fierce Biotech · 28d agoPositive readoutPositive↗ source
  • Zealand Pharma partners with Generate Biomedicines on multispecific obesity proteins in $1.2B deal
    Zealand Pharma has agreed to pay Generate Biomedicines $30 million up front to start work on multispecific protein drug candidates aimed at obesity and other metabolic disorders. The agreement inc…
    Fierce Biotech · 28d agoDealPositive↗ source
  • Astellas marks a decade of CLDN18.2 research, eyeing patient selection and treatment sequencing
    Astellas highlighted a ten‑year journey that took the CLDN18.2 protein from a scientific hypothesis to a validated target in cancer research. The protein, initially noted for its presence on tumor…
    Fierce Biotech · 28d agoPositive↗ source
  • OMass Therapeutics secures $310M Series C, eyes status as Britain’s leading biotech
    OMass Therapeutics, an Oxford‑based biotech still in pre‑clinical stage, announced a new financing round that brings in $310 million. The series C, co‑led by Bain Capital Life Sciences, Forbion an…
    Fierce Biotech · 28d agoDealPositive↗ source
  • GSK to cut up to 1,217 jobs in Belgium as cost-saving plan accelerates
    GSK announced it will lay off up to 1,217 employees in Belgium as part of its global cost-saving program. The cuts will affect R&D, manufacturing and support functions across the company's three m…
    Fierce Biotech · 28d agoLayoffsNegative↗ source
  • Agilent to acquire digital pathology software firm Proscia for $240 million upfront
    Agilent Technologies announced an all‑cash acquisition of Proscia, a digital pathology software specialist, for $240 million upfront with up to $30 million in milestone payments. The deal gives Ag…
    Fierce Biotech · 28d agoDealPositive↗ source
  • UK regulator MHRA unveils multi-year plan to speed AI-driven drug oversight
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released a multi-year strategy aimed at keeping its regulatory framework patient-focused as artificial intelligence and persona…
    raps · 28d agoRegulatoryNeutral↗ source
  • Immune Boost Capital backs Orthrus Therapeutics to advance antigen-specific immune tolerance for rheumatoid arthritis
    Immune Boost Capital, the venture arm of the Arthritis National Research Foundation, announced an investment in Orthrus Therapeutics, a biotech focused on precision therapies for autoimmune disease…
    Fierce Biotech · 28d agoDealPositive↗ source
  • BD and CareFusion recall Alaris Pump infusion sets due to serious performance risks
    The FDA has classified the recall of BD Alaris Pump infusion sets as the most serious type, warning that continued use could cause serious injury or death. BD and its subsidiary CareFusion sent an…
    fda medwatch · 28d agoCRLNegative↗ source
  • Biomea posts modest Phase 1 results for oral GLP-1 drug, shares slide
    Biomea Fusion released Phase 1 data for its oral small‑molecule GLP‑1 agonist BMF‑650, positioning the program as a potential partner opportunity that could separate efficacy from gastrointestinal…
    Fierce Biotech · 28d agoNegative readoutNegative↗ source
  • Verdiva Bio halts phase 2 oral GLP-1 trial after enrolling only eight participants
    Verdiva Bio announced it is ending its phase 2 study of VRB-101, a once‑weekly oral GLP‑1 candidate, after the trial fell far short of its enrollment target. The study was intended to evaluate swi…
    Fierce Biotech · 28d agoNegative readoutNegative↗ source
  • Convenience Kit Recall: AVID Medical Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall
    Avid Medical is removing certain convenience kits affected by the BD ChloraPrep Applicator Recall that may be contaminated with Aspergillus penicillioides.
    fda medwatch · 28d ago↗ source