Keeping Track Of Bad News: Alkermes' Depression Candidate Gets Refuse To File; Teva/Celltrion Biosimilars Land CRLs
The dark side of US FDA review news this week.
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US FDA issued at least seven rejections to novel products; opioid analgesic sponsors had very little success, while biosimilar developers had a so-so year.
The latest drug development news and highlights from our US FDA Performance Tracker.
South Korean biosimilars companies Samsung Bioepis and Celltrion presented new study results, designed to increase overall switching rates away from the branded originator therapies and address prescriber concerns as well as improve administration convenience, at the European League Against Rheumatology (EULAR 2018) held June 13-16 in Amsterdam, Netherlands.