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  • Merck projects continued investment and growth as Keytruda patent expires
    Merck reported third‑quarter results on an investor call, saying sales expectations were above forecasts thanks to strong performance of subcutaneous Keytruda and the pulmonary arterial hypertensio…
    BioSpace · 16d agoEarningsPositive↗ source
  • Labor Dept finalizes PBM disclosure rule to boost transparency for self-insured employers
    The U.S. Labor Department has finalized a rule that will require pharmacy benefit managers to disclose detailed fee and compensation information to self-insured employer clients, with the requireme…
    BioPharma Dive · 16d agoRegulatoryNeutral↗ source
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  • Eli Lilly lifts guidance by $10 billion as GLP‑1 sales outpace expectations
    Eli Lilly said its latest financial guidance is $10 billion higher than previously forecast, driven by strong sales of its GLP‑1 medicines. The company’s commercial performance has repeatedly excee…
    BioSpace · 16d agoEarningsPositive↗ source
  • Voters demand action on soaring health-care costs, boosting support for Medicare for All
    Recent polls show Americans increasingly worried about the rising cost of health care, with many saying it is their top financial concern. Voter anger is directed at politicians, who are seen as f…
    STAT · 16d agoNegative↗ source
  • Dren Bio raises $350 million to advance rare blood cancer antibody
    Dren Bio, a California biotech, announced a $350 million financing round to fund late‑stage development and commercial preparation of its lead therapy, a CD94‑targeting monoclonal antibody known as…
    BioSpace · 16d agoDealPositive↗ source
  • BioMarin signs up to $475 million licensing deal for new Fabry disease enzyme therapy
    BioMarin announced a licensing agreement to acquire rights to a long‑acting enzyme replacement therapy candidate for Fabry disease, paying $70 million upfront and up to $405 million in development…
    Fierce Biotech · 16d agoDealPositive↗ source
  • Biopharma manufacturing cuts slated to affect over 4,000 workers, with BioNTech leading layoffs
    Companies investing billions to reshore drug production are trimming staff at manufacturing sites, with ten biotech and pharma firms planning cuts that could affect more than 4,000 employees. BioN…
    BioSpace · 16d agoLayoffsNegative↗ source
  • Gilead places partial clinical hold on two KITE-753 CAR-T trials in diffuse large B-cell lymphoma
    Gilead announced on its third-quarter earnings call that it has placed a partial clinical hold on two CAR-T trials for KITE-753 targeting diffuse large B-cell lymphoma (DLBCL). The hold affects th…
    Fierce Biotech · 16d agoRegulatoryNegative↗ source
  • Federal rule forces PBMs to disclose fees and rebates to employers
    The Trump administration finalized a regulation that will require pharmacy benefit managers (PBMs) to reveal the various fees and compensation they receive from drugmakers, consultants and other pa…
    STAT · 16d agoRegulatoryPositive↗ source
  • Ono Pharma halts ONO-1110 development for depression and anxiety after five Phase 2 failures, continues pain studies
    Ono Pharma announced that its endocannabinoid modulator ONO-1110 failed to demonstrate efficacy in five Phase 2 trials, prompting the company to stop development for depression and social anxiety.…
    BioSpace · 16d agoNegative readoutNegative↗ source
  • Vertex kidney disease drug faces infection risk scrutiny ahead of FDA decision
    Vertex's kidney disease therapy is expected to receive FDA approval, with the agency's decision scheduled for Nov 30. A previously undisclosed pause rule has drawn attention, raising concerns abou…
    STAT · 16d agoRegulatoryNeutral↗ source
  • Genetic Testing Helps Refine Kidney Disease Trial Design, Says Natera Expert
    In a sponsored episode of The Top Line, Dr. Ronen Schneider, Natera's medical director of renal genetics, explains how genotype‑defined kidney disease data can improve clinical trial design. He not…
    Fierce Biotech · 16d agoPositive↗ source
  • Eli Lilly halts phase 2 Alzheimer's trial of mevidalen after missing internal targets
    Eli Lilly announced it is removing mevidalen from its pipeline, ending a phase 2 trial in symptomatic Alzheimer's disease. The decision was disclosed during the company's third-quarter earnings up…
    Fierce Biotech · 16d agoNegative readoutNegative↗ source
  • Setara Biosciences raises $90M Series A to advance neuroscience pipeline after Jazz's $820M Actio acquisition
    Jazz Pharmaceuticals completed an $820 million purchase of Actio Biosciences in September, creating a new spinout called Setara Biosciences to house the remaining drug programs. Setara has secured…
    Fierce Biotech · 16d agoDealPositive↗ source
  • Delays in reaching clinical proof-of-concept can dramatically increase biotech cash burn
    The article explains how the timing of achieving clinical proof‑of‑concept (POC) directly affects a biotech company's cash consumption. While a study’s cost is important, the ongoing expenses of st…
    Fierce Biotech · 16d agoNegative↗ source
  • Merck says 2027 will focus on pipeline and new product launches despite recent trial wins
    Merck's chief financial officer said the company views 2027 as another year of investment, emphasizing its expanding pipeline and upcoming product launches rather than short‑term margin growth. Th…
    Fierce Biotech · 16d agoEarningsNeutral↗ source
  • Flagship Pioneering merges three biotech startups to launch AI-driven drugmaker Etcelera
    Flagship Pioneering announced the creation of Etcelera Therapeutics by merging three of its portfolio companies - Etiome, Cellarity and Empress Therapeutics. The new venture will combine artificia…
    BioPharma Dive · 16d agoDealPositive↗ source
  • New tumor atlas reveals why colorectal cancer is more aggressive in younger patients
    Researchers have created a new atlas that catalogs 189 colorectal tumor samples from patients aged in their 20s to 90s, aiming to clarify why cancers that arise early are harder to treat. The coll…
    STAT · 16d agoPositive↗ source
  • Australia emerges as a hub for early-stage clinical trials thanks to speed, clear regulations and tax incentives
    A recent episode of BioSpace’s Denatured podcast featured Jerome Barley of Avion Medical and Ryan Klein of Resolian discussing Australia’s growing appeal for early-stage clinical development. The…
    BioSpace · 16d agoPositive↗ source
  • BMS drops $80 million neurodegeneration program after phase-1 results
    BMS announced it will not move forward with a neurodegeneration drug it licensed from Prothena, ending a program it invested $80 million in. The drug, known as BMS-986495 (formerly PRX019), comple…
    Fierce Biotech · 16d agoNegative↗ source
  • Ascletis oral GLP-1 candidate ASC30 meets primary and secondary goals in phase 2 diabetes study
    Ascletis reported that its oral GLP-1 small‑molecule candidate ASC30 achieved both its primary and secondary endpoints in a phase 2 trial involving 100 patients with type 2 diabetes. The study sho…
    Fierce Biotech · 16d agoPositive readoutPositive↗ source
  • BMS shelves Prothena-partnered neuro drug after Phase 1 review, but raises full-year revenue outlook on 7% Q3 sales growth
    Bristol Myers Squibb announced it will not move forward with the neurodegeneration candidate BMS-986495 (PRX019), a monoclonal antibody licensed from Prothena. The decision follows a review of Phas…
    BioSpace · 16d agoNeutral↗ source
  • Treasury's Proposed China Investment Rule Sparks Debate Over Licensing Exemptions
    The U.S. Treasury Department recently proposed a rule that would limit American investment in Chinese biotechnology companies, prompting immediate discussion among industry stakeholders. Commentat…
    STAT · 16d agoRegulatoryNeutral↗ source
  • Eli Lilly consolidates US and international sales under new global markets unit as veteran exec retires
    Eli Lilly announced that long‑time executive Patrik Jonsson will retire after 36 years with the company. Jonsson has been serving as executive vice president and president of Lilly International, o…
    Fierce Biotech · 16d agoNeutral↗ source
  • Michigan Senate candidate El-Sayed rebuts RFK Jr. and highlights FDA's new enforcement discretion on peptide drugs
    Abdul El-Sayed, the Democratic Senate hopeful in Michigan, pushed back against recent statements made by RFK Jr., defending his own health-care positions and emphasizing his background as an immigr…
    STAT · 16d agoRegulatoryNeutral↗ source