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  • AstraZeneca reports positive late-stage results for Tagrisso-Orpathys combo and Enhertu in lung cancer
    AstraZeneca said on Monday that two separate late-stage studies in lung cancer have produced positive outcomes. One study evaluated a combination of the tyrosine-kinase inhibitor Tagrisso with the…
    Endpoints · 27d agoPositive readoutPositive↗ source
  • Eli Lilly signs up to $370 million ion-channel collaboration with OmniAb
    Eli Lilly announced a collaboration and licensing agreement with California-based drug discovery company OmniAb that will focus on ion-channel targets. The deal could see Lilly paying up to $370 m…
    Endpoints · 27d agoDealNeutral↗ source
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  • Slate Medicines secures $245M financing and Nasdaq listing via reverse merger with Fulcrum Therapeutics
    Slate Medicines, a North Carolina biotech, is moving toward a Nasdaq listing through a reverse merger with Fulcrum Therapeutics, six months after emerging from stealth. The transaction includes a…
    Fierce Biotech · 28d agoDealPositive↗ source
  • Chinese biotech CEOs say US tensions won’t curb booming licensing deals
    Chinese biotech CEOs say they are not worried about rising US political tension and regulatory scrutiny. US lawmakers have increased scrutiny, referencing the America First Investment Policy and t…
    Fierce Biotech · 28d agoNeutral↗ source
  • Amylyx's avexitide halves hypoglycemia episodes in phase 3 trial for post‑bariatric patients
    Amylyx Pharmaceuticals reported that its GLP‑1 receptor antagonist avexitide significantly reduced dangerous blood‑sugar drops in a phase 3 study. The double‑blind Lucidity trial enrolled 78 indiv…
    Fierce Biotech · 27d agoPositive readoutPositive↗ source
  • Drugmakers Back US Probe into Germany’s New Drug Pricing Policies
    Seven major pharmaceutical companies, together with industry groups PhRMA and BIO, have urged the German government to amend its recently introduced drug‑pricing reforms. The coalition voiced supp…
    Endpoints · 27d agoRegulatoryNegative↗ source
  • EyePoint’s Phase 3 eye drug falls short of Eylea, stock tumbles 70%
    EyePoint reported that its experimental treatment for wet age-related macular degeneration did not meet the efficacy endpoints in a Phase 3 trial when compared with the current standard, Eylea. The…
    Endpoints · 27d agoNegative readoutNegative↗ source
  • Biotech raises $820M to bring China-sourced immunology drug to market via reverse merger
    A biotech company has secured $820 million in investor commitments this month to bring its immunology drug, developed in China, to public markets. The funding will be used to complete a reverse me…
    Endpoints · 27d agoDealPositive↗ source
  • Summit and Akeso's ivonescimab wins Chinese first-line lung cancer approval, but longer follow-up shows reduced benefit
    Summit Therapeutics and Akeso announced that their next‑generation PD‑1xVEGF bispecific antibody, ivonescimab, received regulatory approval in China for first‑line treatment of certain lung cancer…
    Endpoints · 27d agoApprovalNegative↗ source
  • Argenx reports Phase 3 success for Vyvgart Hytrulo in autoimmune myositis, despite subgroup shortfall
    Argenx announced that its subcutaneous antibody Vyvgart Hytrulo achieved its primary endpoint in a Phase 3 trial for autoimmune myositis, a rare group of inflammatory muscle diseases. The trial de…
    Endpoints · 27d agoPositive readoutPositive↗ source
  • AstraZeneca halts Phase 3 lung cancer trial of volrustomig after negative results
    AstraZeneca announced on Monday that it is ending the Phase 3 study of its lung-cancer drug volrustomig after the trial failed to meet its primary efficacy endpoints. The company said the data did…
    Endpoints · 27d agoNegative readoutNegative↗ source
  • Leo Pharma signs $435 million deal with Tanabe for rare skin disease drug dersimelagon
    Leo Pharma announced a licensing agreement with Mitsubishi Tanabe Pharma for worldwide rights to dersimelagon, an oral melanocortin-1 receptor agonist targeting rare genetic skin disorders. The dr…
    Fierce Biotech · 28d agoDealPositive↗ source
  • Eli Lilly signs up to $370M ion-channel collaboration with OmniAb
    Eli Lilly has entered a collaboration with antibody platform company OmniAb that could involve up to $370 million in research, development and commercial milestone payments. OmniAb, which was spun…
    Fierce Biotech · 28d agoDealPositive↗ source
  • Baylor Genetics suffers cyberattack exposing patient and employee data
    Baylor Genetics, a diagnostic genomics company, announced that an unauthorized third party accessed portions of its network between June 11 and June 17. The breach involved a limited subset of pat…
    Fierce Biotech · 28d agoNegative↗ source
  • AstraZeneca halts phase 3 lung cancer trial of bispecific antibody volrustomig after it falls short of Keytruda
    AstraZeneca stopped its phase 3 trial of the bispecific antibody volrustomig in metastatic non‑small cell lung cancer after interim data suggested the regimen would not meet the study's primary goa…
    Fierce Biotech · 28d agoNegative readoutNegative↗ source
  • FDA releases first updated guidance in 27 years on container and closure systems for drugs and biologics
    The FDA announced a draft guidance that updates the agency’s recommendations for evaluating container and closure systems used in the packaging of new drugs and biologics. This revision is the fir…
    raps · 28d agoRegulatoryNeutral↗ source
  • Experts say AI could outperform doctors on basic tasks by 2030
    Most clinical AI tools being built today are intended to work under a doctor's supervision. Healthcare and venture-capital experts predict that by 2030 AI may independently perform better than phy…
    Endpoints · 27d agoNeutral↗ source
  • Regeneron halts Phase 1/2a uveitis trial of anti-CD3 antibody after safety event
    Regeneron announced it is voluntarily ending the Phase 1/2a TITAN study of its anti‑CD3 monoclonal antibody, REGN7041, which was being evaluated for non‑infectious posterior uveitis. The decision…
    Fierce Biotech · 27d agoCRLNegative↗ source
  • Merck KGaA's US research site to cut 20 jobs amid broader R&D downsizing
    Merck KGaA's North American division, EMD Serono, announced it will lay off 20 employees at its Billerica, Massachusetts research site. The cuts are slated to take effect in the second half of Oct…
    Fierce Biotech · 27d agoLayoffsNegative↗ source
  • Evaxion drops solid tumor vaccine program to prioritize brain cancer vaccine candidate
    Evaxion Biotech announced it has discontinued development of its next‑generation solid tumor vaccine, EVX‑03, and will redirect resources toward a brain cancer vaccine candidate developed with Duke…
    Fierce Biotech · 28d agoNeutral↗ source
  • FDA clears Lantheus' Tauklarify PET imaging agent for Alzheimer’s tau detection
    Lantheus received FDA clearance for its PET imaging agent Tauklarify, also known as MK-6240, which is designed to help diagnose Alzheimer’s disease by visualizing tau protein deposits. The clearan…
    Fierce Biotech · 28d agoRegulatoryPositive↗ source
  • Celcuity waits on FDA review of second plant as cancer drug rollout lags expectations
    Celcuity has announced that it is awaiting the U.S. Food and Drug Administration’s review of a second manufacturing facility needed for its newly approved cancer therapy. The company explained tha…
    Endpoints · 27d agoRegulatoryNeutral↗ source
  • Becton Dickinson recalls intraosseous needle sets over risk of obturator removal difficulty
    Becton Dickinson has issued a recall for specific intraosseous vascular access system needle sets after discovering that the obturator (stylet) can be difficult to remove once the device is placed.…
    fda medwatch · 28d agoCRLNegative↗ source
  • Experts suggest new safety framework to boost predictability of CNS toxicity assessments
    A recent paper outlines a safety framework intended to make central nervous system (CNS) toxicity predictions more reliable during drug development. The authors argue that new approach methodologi…
    raps · 28d agoNeutral↗ source
  • Saudi FDA launches program to accelerate rare-disease drug development
    The Saudi Food and Drug Authority (SFDA) announced a new initiative called the New Accelerator Program for Drugs in Rare Diseases (NADR). The program is designed to speed up the development, evalu…
    raps · 28d agoRegulatoryNeutral↗ source