Biogen
NEWS
On December 28, the U.S. Food and Drug Administration reported there had been 50 novel drug approvals for the year, and that was just for new chemical entities.
Biogen and Eisai reported that the Committee for Medicinal Products for Human Use of the European Medicines Agency had decided not to recommend the drug for its MAA.
Biogen and Eisai released an update on the Phase IV post-marketing confirmatory study and plan to submit the final protocol to the FDA in March 2022 and launch patient screening in May 2022.
A member of BioSpace’s Class of 2021, CODA aims to modify neuronal cell populations using gene therapy to express a tunable ligand-gated ion channel.
The company could lay off as many as 1,000 employees as it continues to deal with the controversial treatment.
Heading out of November and into December, plenty of companies had clinical trial news to report. Here’s a look.
The 12-month data showed that 50 mg of zuranolone was well-tolerated among adults with MDD.
With the Thanksgiving holiday upon us, BioSpace felt it was important to give thanks for some of the positive things that have happened this year. And there are many!
Even before the drug’s approval on June 7, there were cases of amyloid-related imaging abnormalities (ARIA-E), or cerebral edema, observed in the trials.
JOBS
IN THE PRESS