Tags : Plan

Biogen and Eisai Plan to File BLA to the US

Shots: The BLA submission will be based on P-III EMERGE and ENGAGE studies that were discontinued in Mar’2019 following a futility analysis. The new analysis of larger dataset showed that Aducanumab reduced the clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified 1EPs &2EPs EMERGE study result: @78wks. reduction of clinical […]Read More

Chong Kun Dang and Dong-A ST Plan to Launch Nesp

Shots: The companies filed for their Nesp biosimilar in Oct’2018 with its awaited launch in H2’19 The original drug was developed in collaboration with US’ Amgen and Japan’s Kyowa Hakko while the patent expired in the US AND Korea in 2015 and 2024. The worldwide sales for Nesp is expected to be $3B  Nesp (darbepoetin […]Read More