In a first, the U.S. FDA accepted an artificial intelligence (AI)/machine learning-model into its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for drug development. The program will support use of Deliberate AI Inc.’s anxiety and depression assessment tool, called the AI-generated Clinical Outcome Assessment (AI-COA), as a qualified drug development tool.
It is well known that protein tau forms aggregates in the brain in neurodegenerative diseases such as Alzheimer’s disease (AD) that are also known as tauopathies. Accumulation of protein tau in the brain leads to the cell toxicity and promotes the loss of synaptic plasticity, which in turn causes memory loss. As reported on Feb. 1, 2024, in The Journal of Clinical Investigation, assistant professor Tara Tracy and her research team from the Buck Institute for Research on Aging have discovered a protein in the brain that could restore this damage induced by protein tau.
Biogen Inc.’s problematic trip with Aduhelm (aducanumab-avwa) for Alzheimer’s disease at last came to an end as the company, probably surprising few on Wall Street, said it’s quitting sales and development of the amyloid-beta directed antibody. The drug won accelerated approval by the U.S. FDA in July 2021.
Despite Vertex Pharmaceuticals Inc.’s mostly positive phase III study results of a non-opioid for treating moderate to severe acute pain, the data for a key secondary endpoint show VX-548 is not as effective as Vicodin (hydrocodone, Abbvie Inc.). Neither of two randomized, double-blind, placebo-controlled, pivotal studies, one treating patients after abdominoplasty surgery and one after bunionectomy surgery, met the key secondary endpoint of VX-548 being superior to hydrocodone bitartrate/acetaminophen in patients’ pain levels.
Investigators have identified five cases of so-called iatrogenic Alzheimer’s disease (AD), that is, AD that was acquired as a result of undergoing medical procedures. A team led by University College London scientists reported their findings online in Nature Medicine on Jan. 29, 2024.