A first-quarter 2024 launch for Alzheimer’s drug donanemab appears to be off the table as Eli Lilly and Co. disclosed a last-minute decision by the U.S. FDA to convene an advisory committee to review data from the phase III Trailblazer-ALZ 2 trial.
Eisai Co. Ltd. and Oita University in Oita Prefecture, Japan, developed a first-of-its-kind machine learning model to predict amyloid beta accumulation in the brain using a wristband sensor. The model, which collects biological and lifestyle data from daily life, is expected to enable screening for brain amyloid beta accumulation to identify those at risk for Alzheimer's disease, particularly because amyloid beta begins to accumulate in the brain about 20 years before the onset of the disease.
Eisai Co. Ltd. and Oita University in Oita Prefecture, Japan, developed a first-of-its-kind machine learning model to predict amyloid beta accumulation in the brain using a wristband sensor. The model, which collects biological and lifestyle data from daily life, is expected to enable screening for brain amyloid beta accumulation to identify those at risk for Alzheimer's disease, particularly because amyloid beta begins to accumulate in the brain about 20 years before the onset of the disease.
Neurophet Inc. pulled in ₩20 billion (US$15.1 million) in its series C funding round, helping roll out its AI-software suite for neurodegenerative diseases worldwide and prep its IPO on the Kosdaq which is scheduled to take place sometime in 2024.
Irisin is a myokine derived from fibronectin type III domain containing 5 (FNDC5) released into the circulation during physical exercise. It is known that FNDC5/irisin stimulates brain-derived neurotrophic factor (BDNF) expression in the hippocampus and also that Alzheimer’s disease (AD) models and brains and cerebrospinal fluid of AD patients have low levels of irisin.
Galimedix Therapeutics Inc. plans to move its lead compound, GAL-101, into a phase IIa proof-of-concept trial next year, in order to test an intriguing hypothesis associated with certain retinal degeneration conditions. GAL-101 selectively binds misfolded amyloid beta species, and the company believes that this mechanism may benefit patients with the dry form of age-related macular degeneration or with glaucoma.
Strong and complete phase III results for Eli Lilly and Co.’s donanemab for treating early Alzheimer's disease (AD) will no doubt inspire more comparisons with recently approved Leqembi (lecanemab). The newly released data for donanemab show it significantly slowed cognitive and functional decline for those with amyloid-positive early symptomatic AD, which lowered the disease-progression risk.
Questionable efficacy, high priced and risky side effects are some words to describe Leqembi (lecanemab), the latest amyloid beta-targeting antibody approved by the U.S. FDA, Korean experts said, but none of that diminishes the profound significance of the drug for Alzheimer’s disease.
Questionable efficacy, high priced and risky side effects are some words to describe Leqembi (lecanemab), the latest amyloid beta-targeting antibody approved by the U.S. FDA, Korean experts said, but none of that diminishes the profound significance of the drug for Alzheimer’s disease.
Six months after getting accelerated approval from the U.S. FDA without any input from an advisory committee, Eisai Co. Inc. and Biogen Inc.’s Alzheimer’s disease (AD) therapy, Leqembi (lecanemab) will make an appearance June 9 before the Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC), set to discuss the supplemental BLA seeking to convert use of the amyloid beta-targeting antibody to traditional approval.