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Hospital value-based care expands into rural Medicare populations
Cityblock Health announced it will acquire rural provider Homeward Health as it expands its value-based care model to rural and Medicare Advantage populations. In parallel, the company raised $116...
FDA clearance advances blood-based Alzheimer’s evaluation
The FDA cleared PrecivityAD2, a blood test designed to help evaluate Alzheimer’s disease by detecting amyloid pathology. Developed and validated from technology pioneered at Washington University...
European regulators unwind Amgen’s marketing authorization for Tavneos
European regulators ordered a recall of all batches of Amgen’s Tavneos (avacopan) after the European Commission canceled its marketing authorization for the vasculitis treatment earlier this...
New therapy delivery uses non-viral targeted lipid nanoparticles
Researchers reported a targeted lipid nanoparticle (LNP) strategy that enables in vivo gene editing of human blood stem cells without viral vectors. Published in Nature Biomedical Engineering, the...
Clinical-stage immuno-oncology advances in China with 4-1BB bispecific
China’s NMPA accepted the NDA for opamtistomig (LBL-024) for previously treated advanced extrapulmonary neuroendocrine carcinoma. The Center for Drug Evaluation granted priority review, with...
Discovery biology targets replication histone mRNA translation
A study published in Cell Death Discovery identified a molecular mechanism linking ZCCHC4 to the control of replication-dependent histone messenger RNA translation. The work reports that ZCCHC4...
Alzheimer’s and cancer imaging intersects with digital pathology forecasting
A deep-learning pathology model reported in the British Journal of Cancer aims to predict nivolumab outcomes in gastric cancer using tumor microscopic features. The study describes a risk-score...
Parkinson’s targeted degradation blocks alpha-synuclein aggregation triggered by PFF
Researchers reported in npj Parkinson’s Disease that selectively degrading alpha-synuclein can block preformed fibril (PFF)-induced aggregation. The study positions targeted protein degradation as...
Rare neuroimmunology roadmap guides how trials should be designed
A new multi-stakeholder consensus roadmap published in the British Journal of Cancer outlines how clinical trials should be structured for rare childhood central nervous system tumors. The...
AI commercial platform adds medical affairs and market research functions
EVE RSANA expanded its AI-powered commercialization platform with medical information and market research capabilities. The company said the upgraded platform now includes tools for medical...
Regulatory approval and withdrawal in rare disease
European regulators have ordered a recall of all batches of Amgen’s Tavneos (avacopan) after the European Commission canceled its marketing authorization for the vasculitis treatment earlier this...
China NMPA acceptance for 4-1BB targeting bispecific in EP-NEC
China’s NMPA has accepted the new drug application for opamtistomig (LBL-024), a PD-L1/4-1BB bispecific antibody, for use as monotherapy in pretreated advanced extrapulmonary neuroendocrine...
Clinical development momentum for pre-surgery HER2 antibody in early breast cancer
NeoZanHER phase 2 trial results published in Nature Communications are spotlighting zanidatamab in early-stage HER2-positive breast cancer, evaluating the next-generation bispecific antibody...
Oncology trial execution and strategic timing ahead of a major readout
Lundbeck has halted its TED study on the eve of a bexicaserin phase 3 readout, according to the latest update tied to the company’s broader epilepsy program. The pause comes just after Lundbeck...
Biotech funding and reverse merger cash runway
Amylyx has banked $500 million ahead of submission, buoyed by a readout, in what’s framed as a capital strategy to extend runway into regulatory filing. The finance update also notes other market...
Reverse merger for chronic pain drug into U.S. public markets
Ambros Therapeutics’ pain program is moving into public markets through a reverse merger with Werewolf, with the combined company planning a $150 million private placement. The company’s lead...
Capital-light AI commercialization expansion for life sciences workflows
Eversana expanded its AI commercialization platform with new medical affairs and commercial capabilities, adding modules aimed at streamlining medical information workflows, market research...
Data platform launch for single-cell drug toxicity mechanism prediction
DeepCyte launched DeeTox Atlas, a single-cell metabolomic reference atlas designed to map drug toxicity mechanisms. The company said the foundation dataset is built from two independent...
Clinical trial infrastructure and study start mechanics
A new BIOCENTURY analysis lays out how “similar regulatory clocks” can lead to divergent study start timelines, emphasizing operational variables beyond regulatory acceptance. The report argues...
Workforce pressure and clinical trial training pipeline uncertainty at NIH
A report argues NIH has effectively removed a major training ground for clinical trialists by eliminating certain Clinical Trial Required announcements that funded K23 awards. The piece states...