Central Nervous System

EMA accepts Eisai, Biogen’s lecanemab MAA for review to treat AD

The European Medicines Agency (EMA) has accepted for review Eisai and Biogen’s marketing authorization application (MAA) submitted for lecanemab to treat early Alzheimer’s disease (AD).

Eisai submits marketing authorization application for AD therapy in Japan

Eisai has submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency (PMDA) for investigational anti-amyloid beta (Aβ) protofibril antibody lecanemab for early Alzheimer’s Disease (AD) in Japan.

FDA accepts review of Biohaven’s NDA for zavegepant nasal spray

The US Food and Drug Administration (FDA) has accepted review of a new drug application (NDA) filed by Biohaven Pharmaceutical for zavegepant nasal spray.

GNS and Arvinas partner for neurodegenerative disease drug development

GNS Healthcare and Arvinas have entered into a collaboration for generating insights to help expedite neurodegenerative disease drug development.

Roche signs strategic collaboration and licence agreement with Roche

Shape Therapeutics has entered into a multi-target strategic collaboration and licence agreement with Roche to develop gene therapy for particular targets in the areas of Alzheimer’s disease, Parkinson’s disease, and rare diseases.