For the U.S. FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, the medical need and the effectiveness of Eli Lilly and Co.’s Alzheimer’s candidate, donanemab, outweighs the safety concerns and lack of data for underrepresented groups and special needs patients. The panel voted unanimously, 11-0, June 10 that the available data show donanemab is effective in treating Alzheimer’s in the population enrolled in Lilly’s clinical trials and that the benefits of the amyloid-targeting monoclonal antibody outweigh the risks in the study population of patients with mild cognitive impairment and mild dementia.
In what represents its first patenting Demon Curonix BV is seeking protection for a system for providing microvesicles to be used in combination with focused ultrasound for drug delivery to the brain.
Genetic variants in core-spliceosome components are tied to a variety of aberrant splicing-driven inherited disorders. CWF19-like protein 2 (CWF19L2) is such a key component located in the spliceosome complex in charge of maturing pre-RNA. No disease-phenotype has been established for CWF19L2.
Researchers from Charité University Hospital Berlin and affiliated organizations presented data from a study that linked variants in ANO4 to different types of epilepsy.
Shionogi & Co. Ltd. has entered into an option agreement with Cilcare Dev SAS to acquire the exclusive license for the global development, manufacturing and commercialization of hearing loss treatment drug candidates CIL-001 and/or CIL-003.
Phase II-stage Rapport Therapeutics Inc. began trading on Nasdaq June 7 under the ticker RAPP after pricing its IPO of 8 million shares at $17 each to raise $136 million, gaining $3.80, or 22.4%, to close its first day at $20.80. With offices in Boston and San Diego, Rapport is developing drugs for central nervous system (CNS) disorders. The IPO is expected to close June 10.
Washington-based Vanda Pharmaceuticals Inc. has faced a challenging few years involving a federal lawsuit against the U.S. FDA, patent infringement litigation, increasing generic competition and dwindling sales, as well as a complete response letter nixing plans to expand its melatonin receptor agonist Hetlioz (tasimelteon) into insomnia, yet it has recently received a higher, unsolicited acquisition offer of $466 million from a second company, Cycle Pharmaceuticals Ltd.
Although the U.S. FDA unexpectedly sprang the news on Eli Lilly and Co. that it would hold an advisory committee meeting on the BLA for the company’s Alzheimer’s disease drug, donanemab, the agency’s briefing document for the June 10 meeting doesn’t appear to hold any surprises.
Scientists at Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, Suzhou Vigonvita Life Sciences Co. Ltd. and The Xinjiang Technical Institute of Physics & Chemistry of the Chinese Academy of Sciences have disclosed NMDA receptor antagonists reported to be useful for the treatment of neurological disorders.
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