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Personalized mRNA cancer vaccine delivers positive Phase 3 readout
Merck and Moderna reported positive Phase 3 results for their individualized mRNA cancer vaccine intismeran in the INTerpath-001 trial (NCT05933577). In combination with Merck’s Keytruda...
Abcuro raises fresh capital to restart rare inflammatory disorder program
Abcuro said it is adding $66 million to pursue a new path in inclusion body myositis, a rare inflammatory disorder with no approved drugs. The company plans to use the financing to support a study...
Cityblock expands value-based care footprint via Homeward Health deal and Series E
Cityblock Health agreed to acquire Homeward Health as it raises $116 million in a Series E round to scale its value-based care model into rural and Medicare Advantage populations. The transaction...
FDA clears blood test to evaluate Alzheimer’s amyloid pathology
The FDA cleared PrecivityAD2, a blood test designed to help evaluate Alzheimer’s disease by detecting amyloid pathology. The test was developed and validated using technology pioneered at...
Psychedelics regulation: real-world psilocybin program shows safety signal
A new real-world study of Oregon’s state-licensed, nonmedical psilocybin program found the program’s outcomes were largely favorable and overall quite safe. Published in JAMA Network Open, the...
Rare disease trial revival: consensus roadmap for rare childhood CNS tumors
A multi-stakeholder consensus has laid out a roadmap intended to make clinical trials for rare childhood CNS tumors more practical and more inclusive. The effort, published in the British Journal...
Healthcare workforce: Cleveland Clinic AI scribe rollout tied to clinician retention
Cleveland Clinic research reported that an AI scribe rollout improved clinician satisfaction and retention—metrics hospitals increasingly track amid ongoing workforce shortages. The paper...
Oncology translational science: blood test identifies vulnerability in triple-negative spread
Australian researchers identified a molecular vulnerability that may help explain why triple-negative breast cancer is prone to spreading and reported a regulatory-system insight that could enable...
Mechanistic cell biology for cancer: lysosomal dysfunction instead of ceramide buildup
A study in Cell Death Discovery reported that blocking glucosylceramide production kills cancer cells through lysosomal dysfunction rather than through ceramide buildup. The work centers on a...
Early clinical pipeline: zanidatamab shows signal in NeoZanHER phase 2 for HER2-positive breast cancer
Zanidatamab showed promise in the NeoZanHER phase 2 trial evaluating treatment in early-stage HER2-positive breast cancer prior to surgery. The study, published in Nature Communications, tested...
Company moves in value-based care via acquisition and fresh capital
Cityblock Health announced it will acquire rural healthcare provider Homeward Health and simultaneously raised $116 million in a Series E to expand its value-based care model. The combination...
Regulatory clearance for Alzheimer’s diagnostics
FDA cleared PrecivityAD2, a blood test intended to evaluate Alzheimer’s disease risk by detecting amyloid pathology. The test, developed with technology pioneered at Washington University School...
Immuno-oncology regulatory milestone in China
China’s NMPA accepted the NDA for opamtistomig (LBL-024) as monotherapy for previously treated advanced extrapulmonary neuroendocrine carcinoma. The agency’s Center for Drug Evaluation granted...
Clinical evidence for early-stage HER2-directed treatment
NeoZanHER, a phase 2 trial, reported early-stage activity for zanidatamab in patients with HER2-positive breast cancer treated before surgery. Presented as the first look at a preoperative...
Advances in molecular targeting of hard-to-treat cancer
Researchers at Stanford Medicine developed TCIP3, a two-headed experimental therapy that converts a cancer driver into a built-in kill switch rather than simply inhibiting or destroying the...
Early clinical and preclinical work on antibody-based cancer therapy targeting persistence
A.J. Straus, S.K. Kempelingaiah, S. Nguyen and colleagues reported in Cell Death Discovery that blocking glucosylceramide production can kill cancer cells through lysosomal dysfunction rather than...
Biomarker and risk prediction for cancer immunotherapy response
A deep-learning pathology model in the British Journal of Cancer aimed to predict nivolumab outcomes in gastric cancer before treatment. Hong, Hwang, Kim and colleagues describe a risk score...
Neuroscience and neuro-oncology mechanistic discovery tied to immune evasion
Researchers reported in Nature Communications that astrocyte mitochondrial shuttles can awaken dormant glioblastoma cells and help them evade immunity. Zhu, Wang, Wu and colleagues describe how...
AI-enabled genomic regulation mapping relevant to gene-activation biology
A University of California San Diego study used high-throughput sequencing and machine learning to decode DNA sequence features of a human gene-activation initiator. Researchers reported that AI...
Alzheimer’s and clinical trial-readiness policy debate affecting early-career trialists
A report argues that NIH has effectively removed a major training mechanism for clinical trialists by letting “Clinical Trial Required” funding opportunities for K awards wind down under Program...