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1,896 stories matching this filter · ← front page

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  • Vanda pauses social anxiety program after Phase 3 trial misses endpoint in women
    Vanda Pharmaceuticals announced Wednesday that it is halting development of its social anxiety disorder candidate after a late-stage trial did not achieve its primary goal. The experimental drug,…
    Endpoints · 4d agoNegative readoutNegative↗ 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 · 4d agoDealPositive↗ source
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  • Nvidia-backed Iambic Therapeutics raises $150M in IPO, begins trading Thursday
    Iambic Therapeutics, a biotech focused on using artificial intelligence to develop cancer treatments, announced the completion of its initial public offering. The company sold 9.38 million shares…
    Endpoints · 4d 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 · 5d 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 · 5d agoRegulatoryPositive↗ source
  • Former Galapagos CEO Paul Stoffels aims to revive cell therapy projects at new biotech Armed Cell
    Paul Stoffels, who recently stepped down as chief executive of Belgian drug developer Galapagos, is turning his attention to cell‑based therapies. After leaving Galapagos last year, Stoffels has j…
    Endpoints · 4d agoDealPositive↗ 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 · 4d agoNegative readoutNegative↗ source
  • 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 · 4d 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 · 4d 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 · 4d 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 · 4d 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 · 4d 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 · 4d agoNeutral↗ source
  • 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 · 5d agoApprovalPositive↗ 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 · 5d 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 · 5d 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 · 5d agoRegulatoryNeutral↗ 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 · 5d agoRegulatoryPositive↗ 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 · 5d 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 · 5d 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 · 5d 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 · 5d 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 · 5d agoLayoffsNegative↗ source