NATIONAL INSTITUTES OF HEALTH

President-elect Trump's healthcare agency nominations, including Dr. Marty Makary for FDA and Dr. Dave Weldon for CDC, have stirred mixed reactions from industry insiders. The nominees advocate for radical transparency, action on chronic health crises, and skepticism around vaccine schedules, potentially leading to controversial Senate confirmation hearings in 2025. The appointments aim for radical transparency and addressing chronic diseases, but face challenges in distancing from debunked vaccine claims.

Exelixis announced the US FDA will discuss the sNDA for cabozantinib (Cabometyx) for treating advanced pancreatic and extra-pancreatic neuroendocrine tumours at a March 2025 ODAC meeting. The sNDA is based on the phase 3 CABINET trial results, showing cabozantinib's significant improvement in progression-free survival compared to placebo. Cabometyx is approved for various cancers and has received regulatory approvals in over 65 countries.

Eisai and Biogen launch LEQEMBI, a humanized anti-amyloid-beta monoclonal antibody, in South Korea for treating Alzheimer's disease, targeting soluble and insoluble Abeta aggregates to reduce cognitive decline.

SeniorsPlus to launch a $5.5 million capital campaign on December 3 to build a new education and nutrition center at 14 Mollison Way, designed to combat isolation among older adults.

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.