For the second time this week, a contract research organization has come under fire for trial-conduct issues – criticism leveled most recently by Biovie Inc., which saw its shares (NASDAQ:BIVI) tumble $3.03, or 60%, to end Nov. 29 at $1.96 on missed-endpoint data from the phase III trial testing Alzheimer’s disease prospect NE-3107. The data fell short of statistical significance due to site exclusions caused by what Biovie said were “significant good clinical practice violations and protocol deviations.”
Brainspec Inc. received U.S. FDA 510(k) clearance for use of its artificial intelligence platform, Brainspec Core, in noninvasive measurement of brain chemistry using magnetic resonance spectroscopy (MRS).
Researchers from Centre National de la Recherche Scientifique, Inserm, Université Claude Bernard and Université Jean Monnet have synthesized peptides acting as amyloid-β (Aβ) protein aggregation inhibitors reported to be useful for the treatment of amyotrophic lateral sclerosis, cerebral amyloid angiopathy, Down syndrome, Parkinson's disease, Alzheimer's disease and motor neuron disease.
Researchers from Nagoya City University presented the development of a new mouse model with cholinergic dysfunction and amyloid pathogenesis for Alzheimer's 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.
The Alzheimer’s Drug Discovery Foundation (ADFF)’s Diagnostic Accelerator launched the first longitudinal, international study of vocal changes associated with Alzheimer’s disease (AD). Part of a $100 million effort to develop affordable biomarkers for AD, the study hopes to create the world’s largest database of speech and vocal data to facilitate diagnosis and monitoring of neurodegenerative disease.
The latest firm to brave the rough IPO market, Lexeo Therapeutics Inc. made its Nasdaq debut after pricing about 9.1 million shares at $11 per share, raising proceeds of $100 million to advance its early clinical work on gene therapies for cardiovascular and neurological diseases.
One of the main issues encountered by therapeutic antibodies for the treatment of neurodegenerative disorders such as Alzheimer’s disease (AD) is the difficulty of crossing the blood-brain barrier (BBB) to access the central nervous system. To overcome these problems, several attempts have been made using endothelial transmembrane proteins where antibodies can bind. One of these efforts involves transferrin receptor 1 (TfR1).
Aquinnah Pharmaceuticals Inc. has announced preclinical research findings for a novel small-molecule therapeutic designed to slow or stop the progression of Alzheimer's disease and related disorders.
The advent of FDA-approved therapies for Alzheimer’s disease has had some downstream regulatory effects, including that the Centers for Medicare & Medicaid Services recently announced it will eliminate the coverage with evidence development (CED) requirement for PET imaging for beta amyloid imaging for Alzheimer's disease.
