New FDA breakthrough therapy designations awarded for two investigational Alzheimer's disease (AD) candidates, Eli Lilly and Co.'s donanemab and the Bioarctic AB-Eisai Co. Ltd.-developed asset lecanemab (BAN-2401) underline ongoing willingness at the U.S. regulator to invest deeper attention in the potential of amyloid plaque reduction to slow progress of the disease, a critical and costly challenge estimated to affect more than 6 million Americans.
Researchers report in the June 21, 2021, online issue of Neuron that overexpression of the LDL receptor can reduce ApoE to prevent tauopathy-associated neurodegeneration in mouse models.
The FDA’s recent release of documents related to its accelerated approval of Aduhelm (aducanumab) did little to reduce the controversy surrounding that decision and the U.S. pricing of Biogen Inc.’s Alzheimer’s drug.
A deficiency in neurotrophic factor signaling has been shown to exacerbate environmental risk factors for the development of Alzheimer's disease pathogenesis in mice, according to a study reported in the June 22, 2021, online edition of the Proceedings of the National Academy of Sciences.
New FDA breakthrough therapy designations awarded for two investigational Alzheimer's disease (AD) candidates, Eli Lilly and Co.'s donanemab and the Bioarctic AB-Eisai Co. Ltd.-developed asset lecanemab (BAN-2401) underline ongoing willingness at the U.S. regulator to invest deeper attention in the potential of amyloid plaque reduction to slow progress of the disease, a critical and costly challenge estimated to affect more than 6 million Americans.
More than two weeks after the FDA gave its go-ahead to Biogen Inc.’s Aduhelm (aducanumab), controversy still rages over the accelerated approval as well as the price for the anti-amyloid beta monoclonal antibody for Alzheimer’s disease (AD). Embattled U.S. regulators made the uncommon move of releasing documents – with more due to be made public later – that show the internal deliberations that led to Aduhelm’s clearance.
Biogen Inc.’s $56,000-a-year list price for its newly approved Alzheimer’s drug, Aduhelm (aducanumab), is sending tremors through the prescription drug pricing debate that could shift the epicenter of those discussions to drugs granted accelerated approval based on surrogate endpoints.
PERTH, Australia – Digital cognitive assessment technology company Cogstate Ltd. saw its stock skyrocket 60% on the heels of FDA accelerated approval of Biogen Inc./Eisai Co. Ltd.’s Alzheimer’s disease drug Aduhelm (aducanumab). Cogstate and Eisai signed a deal in October 2020 that granted Eisai global development rights and exclusive commercialization rights of all cognitive function tests developed by Cogstate.
LONDON – The pioneers of gene therapy in Europe now aim to take the field to the next level, moving into the development of virally delivered antibodies in the treatment of central nervous system and muscular diseases, with Alzheimer’s disease one of the first targets.
LONDON – Controversy over the quality of the data supporting approval of Biogen Inc.’s Aduhelm (aducanumab), and FDA’s requirement for a phase IV study to demonstrate real-world evidence of the effectiveness of the drug, has put the spotlight on the need for better dementia diagnostics, both to stratify trials and to track any reduction in clinical decline.
