Tag: files

Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that Eisai has submitted a marketing authorization application for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Aβ) protofibril* antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain, to the Ministry of Food and Drug Safety (MFDS) in South Korea. This application is the first application for lecanemab in Asia outside of Japan and China. Eisai plans to submit additional applications in other Asian countries. The application is based ... Read more

Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted a marketing authorization application for lecanemab (Brand Name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril(1) antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency (PMDA). This application is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of ... Read more

On September 27, 2021 Synova S.A. (“Synova”) filed a lawsuit against Sitec Industrietechnologie GmbH (“Sitec”) with the Mannheim District Court for infringement of its patent EP 1 833 636 B1. Synova is the inventor of the water jet guided laser technology Laser MicroJet®. The Synova patent referred to above relates to a core part of this technology. The patent has been granted for major European countries, the USA, Japan, China, South Korea and for Israel. The patented invention allows water jet stabilization for water jet guided laser processing, thus enabling reliable and precise material machining. Sitec offers laser cutting machines ... Read more