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2,198 stories matching this filter · ← front page

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  • 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 · 5d 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 · 5d agoRegulatoryNeutral↗ source
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  • Osivax shifts to combination strategy after Phase 2b flu vaccine setback
    Osivax, a French biotech, reported that its lead influenza vaccine candidate did not meet primary endpoints in a Phase 2b study. The trial, which evaluated the vaccine as a standalone product, sho…
    Endpoints · 5d agoNegative readoutNegative↗ source
  • AI tools push physicians to prioritize clinical reasoning over memorization, experts say
    During a recent Endpoints News panel, health‑tech experts highlighted how artificial‑intelligence applications are reshaping the competencies doctors need. They argued that AI can handle routine d…
    Endpoints · 5d agoPositive↗ 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 · 5d agoNeutral↗ source
  • NorthStar Medical Technologies partners with Chinese CRO Quarkmed, while Lonza outlines mid-term guidance
    NorthStar Medical Technologies, a maker of radioisotopes, announced a new partnership with Beijing-based contract research organization Quarkmed. Under the agreement, Quarkmed will provide contrac…
    Endpoints · 5d agoDealNeutral↗ 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 · 5d agoDealNeutral↗ source
  • CDC removes pregnancy-specific Covid-19 vaccine guidance page after online backlash
    The CDC briefly posted a webpage that clearly endorsed Covid-19 vaccination for individuals planning to become pregnant. The page was later taken down and now redirects to another section of the C…
    Endpoints · 5d agoRegulatoryNeutral↗ source
  • Rock Health summit in San Francisco offers a mid-year health AI landscape check
    The author traveled to San Francisco to attend Rock Health's annual summit, noting it was the first visit in six months. The event gathered health-technology leaders and investors, focusing on the…
    Endpoints · 5d agoNeutral↗ 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 · 5d ago↗ source
  • Sanofi R&D chief urges Western pharma to factor China’s growing innovation into pipelines
    Sanofi’s newly appointed head of research and development said on Wednesday that Western pharmaceutical companies can no longer overlook China’s rapid progress in biopharma innovation. He noted th…
    Endpoints · 6d agoNeutral↗ 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 · 6d 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 · 6d agoDealPositive↗ source
  • FDA proposes new framework prioritizing consistency over flexibility for rare disease drug reviews
    The FDA announced a shift in its approach to evaluating rare disease therapies, emphasizing a more uniform assessment process. Agency officials explained that the flexibility shown over the summer…
    Endpoints · 6d agoRegulatoryNeutral↗ source
  • Ultragenyx sells second priority review voucher as Biomea shares tumble after oral GLP-1 data
    Ultragenyx Pharmaceutical, a commercial-stage rare disease company, completed its second sale of a priority review voucher this month. The voucher sale reflects the company's strategy of monetizin…
    Endpoints · 6d agoDealNeutral↗ source
  • Vir Biotechnology signs $65M upfront deal with Gilead for solid tumor T-cell engager
    Vir Biotechnology announced a new collaboration with Gilead Sciences focused on a solid tumor T-cell engager. Under the agreement, Gilead will provide an upfront payment of $65 million and up to $…
    Endpoints · 6d agoDealPositive↗ source
  • Arrowhead’s RNA drug cuts Alzheimer’s tau protein in early human study
    Arrowhead Pharmaceuticals reported early-stage data showing its subcutaneous RNA therapeutic can reach the brain and lower tau protein, a hallmark of Alzheimer’s disease. In a first-in-human trial…
    Endpoints · 6d agoPositive readoutPositive↗ source
  • Zealand Pharma signs up to $1.3 billion AI partnership with Generate Biomedicines for protein-based obesity drugs
    Zealand Pharma announced a partnership with Generate Biomedicines to develop new protein-based treatments targeting obesity and related metabolic conditions. The collaboration will use Generate's…
    Endpoints · 6d agoDealPositive↗ source
  • GSK to cut up to 1,200 jobs in Belgium as part of cost-cutting plan
    GSK said it will make up to 1,217 workers redundant from its facilities in Belgium. The job reductions are part of a cost-cutting programme that CEO Luke Miels first outlined in July. The announc…
    Endpoints · 6d 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 · 6d 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 · 6d 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 · 6d 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 · 6d 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 · 6d 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 · 6d agoDealPositive↗ source