Author Archives: Teresa Carvalho MSc

Eisai Starting Process of Requesting Lecanemab’s Approval in Japan

Eisai has started submitting data to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in support of an application for approval of its investigational lecanemab (BAN2401) to treat early Alzheimer’s disease. This submission followed the company’s prior assessment consultation with the PMDA, given in advance of an approval application and intended…

Trial of Oral Varoglutamstat Cleared to Take Place in China

A clinical trial application for varoglutamstat, or PQ912, an investigational therapy for Alzheimer’s disease, was approved in China, its developers, Vivoryon Therapeutics and Simcere Pharmaceutical Group, announced. “We are proud to have obtained [China’s Center for Drug Evaluation] CDE approval of our Clinical Trial Application of varoglutamstat…