NATIONAL INSTITUTES OF HEALTH

Eisai launches Leqembi in South Korea for mild cognitive impairment due to Alzheimer's disease. Leqembi selectively binds to amyloid-beta aggregates, reducing disease progression and cognitive decline. Developed by BioArctic and Eisai, it's the first treatment to show efficacy through this mechanism.

Dana-Farber researchers developed a machine learning model using genomic heterogeneity and ploidy to predict resistance to anti-PD-1 therapy in metastatic melanoma, validated in four cohorts. The model suggests 43% of predicted resistant patients respond to combination therapy, potentially guiding treatment choices.

Eisai and Biogen launch LEQEMBI, a humanized anti-soluble aggregated amyloid-beta monoclonal antibody, in South Korea for treating mild cognitive impairment due to Alzheimer's disease or mild AD dementia. LEQEMBI selectively binds to soluble and insoluble Aβ aggregates, reducing both protofibrils and plaques in the brain, and is the first treatment shown to slow cognitive and functional decline through this mechanism.

Eisai and Biogen launch LEQEMBI in South Korea, a humanized anti-soluble aggregated amyloid-beta monoclonal antibody for mild cognitive impairment due to Alzheimer's disease or mild AD dementia. LEQEMBI selectively binds to soluble and insoluble Aβ aggregates, reducing both protofibrils and plaques in the brain, and is the first treatment shown to slow cognitive and functional decline.

NIH developed AI algorithm TrialGPT to match potential volunteers for clinical trials, reducing screening time by 40% while maintaining accuracy. The tool aims to enhance trial recruitment and reduce participation barriers for underrepresented populations.

Negotiations for FY 2025 appropriations are ongoing, impacting NIH funding; President-elect Trump's nominees for HHS, CMS, CDC, FDA, and Surgeon General spark concern in the medical research community; House Appropriations Subcommittee reviews NIH budget for FY 2025; AACR and FDA host workshops on DPD deficiency and clinical trials; U.S. Surgeon General highlights tobacco use disparities; FDA approves new drugs and updates product labeling.

Meta-analysis of 40 RCTs (11,576 patients) shows surgical-based locoregional therapies (LRTs) for nonmetastatic hepatocellular carcinoma (HCC) yield best outcomes; embolization-based LRTs poorer. Hierarchical efficacy observed: surgery with adjuvant therapy > surgery alone > radiofrequency ablation (RFA) > microwave ablation (MWA) and radiotherapy (RT) > hepatic arterial infusion chemotherapy (HAIC) > transarterial chemoembolization (TACE) > transarterial radioembolization (TARE) and transarterial bland embolization (TAE). Findings suggest LRT remains crucial in HCC treatment, with some forms preferred over others.

PTC Therapeutics' Phase II trial of utreloxastat for ALS failed to meet primary endpoints, leading to trial termination. Utreloxastat was safe but lacked efficacy, prompting the company to halt further development. PTC sold its Rare Pediatric Disease Priority Review Voucher for $150 million to maintain operations.