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2,408 stories matching this filter · ← front page

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  • Kyverna reports one-year mobility gains and safety for CAR-T miv-cel in stiff-person syndrome, bolstering FDA filing plans
    Kyverna Therapeutics presented data from its Phase 2 KYSA-8 trial of miv-cel, a CAR-T therapy aimed at stiff-person syndrome (SPS). The study followed 26 patients for one year. At the one-year mar…
    BioSpace · 27d agoPositive readoutPositive↗ source
  • Acadia misses mark in Alzheimer’s but concludes phase 3 ‘absolutely worth’ pursuing
    Acadia Pharmaceuticals’ phase 2 Alzheimer’s disease trial has missed its primary endpoint, but the company and analysts alike saw enough encouraging signals to support the continuation of a phase 3…
    Fierce Biotech · 27d agoNegative readoutNegative
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  • Roche signs up to $2 billion partnership with Atavistik to develop cardiometabolic drugs
    Roche announced a partnership with Atavistik Bio, a biotech focused on hematology, to pursue new small-molecule treatments for cardiovascular, renal and metabolic conditions. The agreement provide…
    BioSpace · 27d agoDealPositive↗ source
  • Eli Lilly earmarks up to $3.25 billion for partnership with InnoCare Pharma
    Eli Lilly announced an upfront payment of $100 million to Beijing‑based InnoCare Pharma to start work on drug candidates for five targets that have critical unmet medical needs. The agreement also…
    BioSpace · 27d agoDealNeutral↗ source
  • Radioligand therapy gains momentum as experts discuss expanding patient impact
    In a recent episode of the Denatured podcast presented by Curium, host Jennifer Smith-Parker spoke with Mike Patterson, CEO North America, and Sabine Brookman-May, Vice President and Head of Global…
    BioSpace · 27d agoPositive↗ source
  • Henlius Biotech signs $440 million deal with Amberstone to develop T-cell engagers
    Henlius Biotech, a subsidiary of Fosun Pharma, announced a licensing agreement with California‑based Amberstone Biosciences valued at up to $440 million. The partnership will focus on creating anti…
    Fierce Biotech · 27d agoDealPositive↗ source
  • Eli Lilly partners with China’s InnoCare on drug development deal worth up to $3.35 billion
    Eli Lilly has signed a partnership agreement with Beijing-based InnoCare to co-develop new medicines. InnoCare will apply its internal drug discovery platform while Lilly will contribute its devel…
    Endpoints · 27d agoDealPositive↗ source
  • Roche signs $2 billion deal with Atavistik to discover allosteric cardiovascular-renal-metabolic drugs
    Roche announced a partnership with Cambridge-based biotech Atavistik Bio to develop allosteric small-molecule therapies for cardiovascular, renal and metabolic diseases. The agreement includes an u…
    Fierce Biotech · 27d agoDealPositive↗ source
  • Eli Lilly commits $100M upfront in new five-target partnership with China's InnoCare
    Eli Lilly has agreed to pay $100 million upfront and in the near term to Chinese biotech InnoCare Pharma as part of a five‑target drug discovery partnership. The agreement also provides for up to $…
    Fierce Biotech · 27d agoDealPositive↗ source
  • FDA warns Houston compounding pharmacy of unsanitary GLP-1 production risking contamination
    FDA issued a warning letter to Empower Clinic Services, operating as Empower Pharmacy, after inspectors found unsanitary conditions at its Houston compounding site. Inspectors observed that the ph…
    BioSpace · 27d agoRegulatoryNegative↗ source
  • Roche signs discovery partnerships with Atavistik Bio and Earendil Labs
    Roche announced new collaborations with the drug discovery companies Atavistik Bio and Earendil Labs to develop early-stage candidates. The agreements continue a recent wave of dealmaking by the S…
    Endpoints · 27d agoDealNeutral↗ source
  • Acadia’s Alzheimer’s psychosis drug misses Phase 2 goals, but moves to revised Phase 3
    Acadia Pharmaceuticals announced that its experimental treatment for psychosis linked to Alzheimer’s disease failed to meet the primary endpoints in a Phase 2 trial. The company said the data stil…
    Endpoints · 27d agoNegative readoutNegative↗ source
  • Acadia’s Alzheimer’s psychosis drug misses primary goal but advances on secondary data
    Acadia Pharmaceuticals reported that its investigational drug remlifanserin failed to meet the primary endpoint in the Phase 2 portion of the RADIANT trial for Alzheimer’s disease psychosis. The t…
    BioSpace · 27d agoNegative readoutNeutral↗ source
  • Merck’s eye-drug matches Lucentis in vision improvement but raises safety concerns
    Merck reported results from its Phase 2b/3 BRUNELLO trial of remigromig, a Wnt-pathway agonist for diabetic macular edema. The drug achieved non-inferior improvement in best-corrected visual acuit…
    BioSpace · 27d agoNegative readoutNegative↗ source
  • Basecamp Research secures $140 million Series C to accelerate AI-designed drug pipeline
    Basecamp Research announced closing a $140 million Series C financing round to further develop its AI-driven drug discovery platform. The round was led by venture firm S32 and included participati…
    BioSpace · 27d agoDealPositive↗ source
  • Merck's $1.3B EyeBio investment yields first ophthalmology success
    Merck's strategic move to re-enter ophthalmology has begun to show results after its 2024 acquisition of EyeBio. The company committed $1.3 billion upfront for EyeBio, aiming to broaden its pipeli…
    Endpoints · 27d agoDealPositive↗ source
  • Kyverna reports positive one-year CAR-T results for rare stiff person syndrome, supporting FDA filing
    Kyverna Therapeutics announced that its CAR-T therapy for stiff person syndrome showed positive results after one year of treatment. The trial involved patients with the rare autoimmune disorder,…
    Endpoints · 27d agoPositive readoutPositive↗ source
  • Adagio Medical begins strategic review and cuts over half its workforce amid Nasdaq delisting risk
    Adagio Medical, a maker of cryoablation devices, announced it is launching a strategic review of its operations. As part of the review, the company will lay off more than half of its full‑time sta…
    Fierce Biotech · 27d agoLayoffsNegative↗ source
  • Grail's Galleri blood test receives positive FDA advisory panel vote, moving closer to approval
    Grail's multi‑cancer blood test Galleri earned a favorable recommendation from the FDA's medical devices advisory committee, bringing the test one step nearer to U.S. market clearance. The panel v…
    Fierce Biotech · 28d agoRegulatoryPositive↗ source
  • China NewCo model pioneer sued in US over alleged trade secret theft and double-dealing
    A lawsuit filed in New York and later moved to federal court accuses Su Zhang, a consultant known for shaping the China "NewCo" dealmaking model, of misusing trade secrets and engaging in double-de…
    Fierce Biotech · 27d agoNegative↗ source
  • Elevar Therapeutics receives FDA approval for Lyrfigtu as second-line treatment for bile duct cancer
    The U.S. Food and Drug Administration has approved Elevar Therapeutics' drug Lyrfigtu as a second‑line option for patients with bile duct cancer who meet specific criteria. Bile duct cancer is dia…
    Endpoints · 27d agoApprovalPositive↗ source
  • FDA nominee Heidi Overton affirms safety of vaccines and mifepristone in Senate hearing
    Heidi Overton, the Trump administration’s pick for FDA commissioner, appeared before the Senate Health, Education, Labor and Pensions Committee to answer questions about her views on key public‑hea…
    Fierce Biotech · 27d agoRegulatoryNeutral↗ source
  • Series B funded biotechs expand hiring, Tenpoint Therapeutics raises $85M for eye-health pipeline
    Companies that secured series B rounds this year are scaling up their staff, making them attractive targets for biopharma talent. Tenpoint Therapeutics, based in Warren, New Jersey, announced an $…
    BioSpace · 27d agoDealPositive↗ source
  • Travere appoints former Amicus CEO Bradley Campbell as new chief executive
    Travere Therapeutics CEO Eric Dube is stepping down after overseeing the launch of the rare kidney disease drug Filspari. Bradley Campbell will assume the role on Dec 1, bringing experience from l…
    Fierce Biotech · 27d agoNeutral↗ source
  • AI doomsday warnings may curb health-tech innovation, Epic cautions
    Recent commentary warns that sensational AI doomsday predictions could slow the pace of health‑technology innovation. Epic, the large electronic health‑record company that provides AI tools to hos…
    Endpoints · 27d agoNegative↗ source