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  • FDA advisory panel finds Grail's Galleri multicancer blood test benefits outweigh risks
    A Food and Drug Administration advisory panel voted 7-2, with one abstention, to conclude that the probable benefits of Grail's Galleri multicancer blood test outweigh its risks. The panel unanimou…
    BioPharma Dive · 1mo agoRegulatoryPositive↗ 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 · 1mo agoDealPositive↗ source
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  • 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 · 1mo 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 · 1mo 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 · 1mo agoDealPositive↗ source
  • Merck's remigromig meets visual acuity goal in diabetic macular edema trial, safety signals noted
    Merck announced that its experimental eye drug remigromig achieved non‑inferiority to Roche’s Lucentis in a late‑stage trial for diabetic macular edema. The trial, called Brunello, measured visual…
    BioPharma Dive · 1mo agoPositive readoutNeutral↗ 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 · 1mo 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 · 1mo agoNegative readoutNegative↗ source
  • Eli Lilly inks $3.35 B China partnership as Immunovant halts lupus drug trial
    Eli Lilly announced a new alliance with Beijing‑based InnoCare Pharma that could be worth up to $3.35 billion. The deal includes an upfront payment of $100 million and up to five target programs fo…
    BioPharma Dive · 1mo agoDealNeutral↗ 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoRegulatoryNeutral↗ 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 · 1mo 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 · 1mo agoNegative↗ source
  • Merck sees pivotal victory for $3B eye disease prospect
    Merck & Co.’s Brunello trial has hit its primary endpoint, shedding light on the effects of a trispecific diabetic macular edema (DME) drug candidate that the Big Pharma bought in a $3 billion take…
    Fierce Biotech · 1mo agoRegulatoryNeutral↗ source
  • Sarepta Therapeutics agrees to pay $39 million to settle gene therapy dispute with Regenxbio
    Sarepta Therapeutics has agreed to resolve a dispute with Regenxbio by paying $39 million. The payment settles claims related to gene therapy technology that both companies have been developing.…
    Endpoints · 1mo agoDealNeutral↗ source
  • Heidi Overton, Trump’s FDA commissioner nominee, to face Senate confirmation hearing
    Heidi Overton has been nominated by President Donald Trump to serve as the next commissioner of the U.S. Food and Drug Administration. She is scheduled to appear before the Senate Health, Educatio…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • FDA nominee Overton parries vaccine questions at Senate hearing
    Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on key decisions and work to speed early drug research.
    BioPharma Dive · 1mo ago↗ source
  • FDA approves Eli Lilly's once-weekly insulin pen, setting up rivalry with Novo
    Eli Lilly’s once-weekly basal insulin shot Onswik has been approved by the FDA for patients with type 2 diabetes. Lilly has touted Onswik as a longer-acting alternative to daily basal insulin injec…
    Endpoints · 1mo ago↗ source
  • Roche reports phase 3 success for sefaxersen in IgA nephropathy, eyes accelerated approval
    Roche announced that its experimental drug sefaxersen met the primary endpoint in a phase 3 trial for IgA nephropathy, showing reduced proteinuria versus placebo. The interim analysis at week 37 d…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Roche and Ionis report positive Phase 3 interim results for IgA nephropathy drug sefaxersen
    Roche and Ionis announced that their experimental RNA therapy sefaxersen met its primary endpoint in an interim analysis of a Phase 3 trial for IgA nephropathy. The trial showed statistically sign…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source