Keeping Track Of Bad News: Alkermes' Depression Candidate Gets Refuse To File; Teva/Celltrion Biosimilars Land CRLs

08 Apr 2018

• By Michael Cipriano

The dark side of US FDA review news this week.

While several companies got some positive news by bringing their products to the US FDA, Alkermes PLC, Teva Pharmaceutical Industries Ltd. and Celltrion Inc. ran into agency roadblocks to highlight the bad news of the week.

FDA handed Alkermes a refuse-to-file (RTF) letter for its major depressive disorder (MDD) drug ALKS 5461, citing a lack of evidence of efficacy.

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