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  • FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancer
    The U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that ha…
    fda press · 26d agoApprovalPositive↗ source
  • Gilead invests up to $1.87 B in Vir Biotechnology for three T-cell engagers
    Gilead Sciences announced a licensing agreement with Vir Biotechnology that includes an equity investment and potential milestone payments totalling up to $1.87 billion. The upfront component is $…
    BioSpace · 26d agoDealPositive↗ source
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  • Verastem reports robust response in pancreatic cancer subgroup where Revolution's drug lagged
    Verastem Oncology announced that its KRAS G12D‑targeting inhibitor VS‑7375 showed strong activity in a Phase 1/2 trial that includes patients with advanced solid tumors. In the pancreatic cancer co…
    BioSpace · 26d agoPositive readoutPositive↗ source
  • Zealand Pharma to invest up to $1.2 billion in Generate’s AI platform for obesity drug development
    Zealand Pharma announced a partnership with Generate:Biomedicines to use the latter's generative‑AI platform for creating new multispecific drug candidates aimed at obesity and metabolic disorders.…
    BioSpace · 26d agoDealPositive↗ 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 · 26d agoPositive readoutPositive↗ source
  • J&J Q3 earnings fall short of expectations as stock slides, BMS reports mixed trial outcomes and RevMed highlights subgroup data
    Johnson & Johnson reported third‑quarter results that met analyst forecasts, driven by its innovative medicines segment, but the company’s stock dropped about 4% as the med‑tech division lagged beh…
    BioSpace · 27d agoEarningsNegative↗ 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 · 27d agoDealPositive↗ source
  • FDA launches Rare Disease Framework Initiative to reshape drug development for small patient populations
    The FDA announced a new Rare Disease Framework Initiative aimed at overhauling how drugs and biologics for rare conditions are developed. The initiative will produce a tailored framework that refl…
    fda press · 26d agoRegulatoryPositive↗ source
  • GSK to cut over 1,200 jobs at Belgian sites as $2.5 bn restructuring continues
    GSK announced it will eliminate more than 1,200 positions across its Belgian facilities, following an earlier closure of a German vaccine plant that cut about 650 jobs. The reductions are part of…
    BioSpace · 26d agoLayoffsNegative↗ 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 · 27d 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 · 27d 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 · 27d 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 · 27d 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 · 27d 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 · 26d agoDealPositive↗ source
  • European biotech CEOs divided on whether US or China will lead future partnership deals, Europe seen as lagging
    A BIO-Europe survey of 81 leaders from privately‑owned European biotech companies found the group split on which region will dominate future innovation partnerships. Twenty‑nine respondents said th…
    BioSpace · 27d agoNeutral↗ source
  • Jazz CEO urges industry to boost gender diversity in biopharma leadership
    Renee Gala, the newly appointed chief executive of Jazz, said her own sponsors took chances on her and urged the biopharma sector to do the same to revive momentum for gender equity in leadership.…
    BioSpace · 27d agoNeutral↗ 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 · 27d 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 · 26d agoNegative readoutNegative↗ source
  • FTC seeks contempt ruling against Martin Shkreli for breaching lifetime pharma ban
    The Federal Trade Commission has asked a judge to hold Martin Shkreli in contempt for allegedly breaching the lifetime ban that was imposed after his 2022 release from prison. The agency alleges t…
    BioSpace · 26d agoRegulatoryNegative↗ source
  • Verdiva ends mid-stage study of oral GLP-1 amid ‘market evolution’
    The candidate is an oral version of ecnoglutide, a subcutaneous formulation of which is approved in China for type 2 diabetes and weight management. Pfizer owns commercialization rights for ecnoglu…
    BioSpace · 26d ago↗ source
  • Gilead signs $1.9 billion deal with Vir Biotechnology to license dual-masked T-cell engagers for oncology
    Gilead Sciences announced a licensing agreement with Vir Biotechnology to access Vir's dual-masked PRO-XTEN T-cell engager platform for oncology. Under the deal, Vir will discover, design and opti…
    Fierce Biotech · 27d agoDealPositive↗ source
  • iOnctura’s roginolisib shows encouraging phase 1 results in metastatic uveal melanoma
    iOnctura, a spinout of Merck KGaA, reported data from a two‑part phase 1 trial of its PI3K delta inhibitor roginolisib in patients with advanced solid and hematologic cancers, including a cohort of…
    Fierce Biotech · 27d agoPositive readoutPositive↗ source
  • Stryker invests $400 million in CMR Surgical, securing exclusive U.S. rights to Versius robotic platform
    Stryker announced a strategic investment of about $400 million in UK‑based CMR Surgical, a developer of modular, portable surgical robots. Under the agreement, Stryker will act as the exclusive U.…
    Fierce Biotech · 27d agoDealPositive↗ source
  • IQVIA and Veeva deepen partnership to accelerate clinical trial timelines
    IQVIA and Veeva Systems announced an expansion of their existing collaboration aimed at speeding up clinical trial execution and improving efficiency. The upgrade brings Veeva's trial management t…
    Fierce Biotech · 27d agoDealPositive↗ source