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FDA Accepts Biogen's New Drug Application and Grants Priority Review of Tofersen for a Rare, Genetic Form of ALS Seite 1

26.07.2022 - SOD1-ALS is a rare genetic form of ALS that affects approximately 330 people in the U.S.,1 it is progressive, leads to the loss of everyday functions and is uniformly fatalIf approved, tofersen would be the first treatment to target a genetic cause ... Seite 1
United Kingdom Priya Singhal Regulatory Sciences Drug Administration Advisory Committee Biogen Inc

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Sage Therapeutics, Biogen highlight data showing zuranolone well-tolerated in MDD

Sage Therapeutics Inc. and Biogen Inc. released 12-month data showing zuranolone was generally well-tolerated among adults with major depressive disorder. A total of 199 patients received zuranolone 50 mg once per night for 2 weeks as their initial dose in the ongoing phase 3 open-label SHORELINE Study, with potential for 12 months of follow-up. The study is part of the LANDSCAPE clinical program
Priya Singhal Barry Greene Sage Therapeutics Inc Regulatory Sciences Biogen Inc Sage Therapeutics
Source: healio.com

Sage Therapeutics and Biogen Announce Positive, One-Year Zuranolone 50 mg Data in the Ongoing Open-Label SHORELINE Study in Patients with MDD

In the zuranolone 50 mg cohort, the majority of patients who responded to an initial 14-day course received only one two-week course of treatment during the study and nearly 80% received only one or... | December 1, 2021
Priya Singhal Barry Greene Walter Gilbert Charles Weissmann Heinz Schaller Kenneth Murray

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