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1,332 stories matching this filter · ← front page

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  • 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 · 3d 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 · 3d agoNegative↗ source
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  • 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 · 3d agoNegative readoutNegative↗ 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 · 2d 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 · 2d 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 · 2d 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 · 2d 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 · 3d 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 · 2d agoRegulatoryNeutral↗ source
  • Slate Medicines to merge with Fulcrum Therapeutics after Fulcrum drops sickle-cell drug
    Slate Medicines announced it will combine with Fulcrum Therapeutics in a reverse merger, giving the struggling biotech a new corporate home. Fulcrum had been developing pociredir, a therapy design…
    BioPharma Dive · 2d agoDealNegative↗ source
  • Trump orders MMR vaccine as LSD-targeted drug passes Phase 3 trial
    The latest Endpoints Weekly notes that President Trump placed an order for the measles‑mumps‑rubella (MMR) vaccine. The newsletter also reports that a drug being developed for LSD‑related indicati…
    Endpoints · 4d agoPositive readoutNeutral↗ source
  • Biotech firm Biogen secures Chinese approval for felzartamab in second-line multiple myeloma
    Biogen announced that its monoclonal antibody felzartamab has received regulatory clearance in China for use in patients with multiple myeloma who have already received first-line therapy. The app…
    Endpoints · 5d agoApprovalPositive↗ source
  • Capricor shares jump as FDA signals openness to review updated Duchenne therapy
    Capricor Therapeutics saw its stock rise sharply after CEO Linda Marbán told analysts that the FDA is willing to look at an amended filing for its Duchenne muscular dystrophy cell therapy, deramioc…
    BioPharma Dive · 5d agoRegulatoryPositive↗ source
  • Two undisclosed gene-therapy deaths raise doubts about China's fast-track trial pathway
    Two recent deaths in China’s early‑stage gene‑therapy trials have drawn international attention. Both patients suffered severe immune reactions after receiving high‑dose viral vector treatments, an…
    Fierce Biotech · 5d agoRegulatoryNegative↗ source
  • FDA grants accelerated approval to Bristol Myers' Zenbexus, first CELMoD for multiple myeloma
    The FDA issued an accelerated approval on Thursday for Zenbexus, a multiple myeloma therapy that Bristol Myers Squibb inherited from its Celgene acquisition. Zenbexus belongs to a new class of pro…
    BioPharma Dive · 5d agoApprovalPositive↗ source
  • Skye Bioscience and Redx Pharma combine to form Fibrx Therapeutics with $125M financing for fibrosis pipeline
    Skye Bioscience announced a combination with privately held Redx Pharma, creating a new public company called Fibrx Therapeutics. The transaction is structured as a reverse merger and provides $12…
    Fierce Biotech · 5d agoDealPositive↗ source
  • New state and federal funding fuels biotech hub growth in Pennsylvania, Kansas City and beyond
    Government programs in Pennsylvania, New York, Kansas City and Central Virginia are pouring new funding into regional biotech hubs as pharma manufacturing investment surges. Matt Gardner, sector p…
    BioPharma Dive · 5d agoPositive↗ source
  • Capricor plans FDA amendment after advisory committee rejects cardiomyopathy endpoint, stock jumps
    Capricor Therapeutics received a negative vote from an FDA advisory committee on the efficacy of its cell therapy, deramiocel, for treating cardiomyopathy in Duchenne muscular dystrophy. The nine‑t…
    Fierce Biotech · 5d agoRegulatoryPositive↗ source
  • MapLight shifts focus to schizophrenia drug after mixed Phase 2 results, raises $150 million
    MapLight Therapeutics reported mixed outcomes from its Phase 2 Zephyr trial of the muscarinic agonist ML-007C-MA. A twice‑daily dose achieved the study’s primary endpoint with notable reductions in…
    Fierce Biotech · 6d agoDealNeutral↗ source
  • Capricor to submit additional data to FDA after negative advisory committee vote on Duchenne therapy
    Capricor Therapeutics announced it will request the FDA to review new data and analyses for its experimental treatment for Duchenne muscular dystrophy. The move follows a recent negative vote from…
    Endpoints · 5d agoRegulatoryNegative↗ source
  • Abcuro raises $66 million to launch Phase 3 trial in muscle-weakening disease after earlier setback
    Abcuro announced it has secured $66 million in financing to support a Phase 3 clinical study targeting a muscle-weakening condition. The funding comes after the company previously reported that it…
    Endpoints · 5d agoDealNeutral↗ source
  • ICER finds AstraZeneca’s blood pressure pill Baxfendy not cost-effective at $10,950 a year
    ICER released a report saying the clinical benefits of AstraZeneca’s new blood pressure medication Baxfendy do not justify its listed price. The agency noted the drug is priced at $10,950 per pati…
    Endpoints · 5d agoRegulatoryNegative↗ source
  • Redx Pharma pursues new reverse merger with Skye after 2023 setback
    Redx Pharma, a UK biotech focused on ROCK inhibitor therapies for fibrosis, is seeking a reverse merger with Skye to obtain a Nasdaq listing. The company previously attempted a similar transaction…
    Endpoints · 5d agoDealNeutral↗ source
  • Bicara appoints President Ryan Cohlhepp as CEO effective Jan. 1, while J&J veteran John Reed joins Madrigal board
    Bicara Therapeutics announced a leadership transition, naming its current President and COO Ryan Cohlhepp as the new chief executive officer effective Jan. 1. Cohlhepp will take over the role as t…
    Endpoints · 5d agoNeutral↗ source
  • Cytokinetics sues Bristol Myers Squibb over recently granted patent, intensifying rivalry
    Cytokinetics has filed a lawsuit against Bristol Myers Squibb, seeking to invalidate a patent that was recently granted to the latter. The legal action adds a courtroom dimension to an already com…
    Endpoints · 5d agoCRLNegative↗ source