Keeping Track: Biosimilar Submissions Galore (And An Approval), Bayer Gets An Oncology Approval, KemPharm Resubmits Apadaz NDA
Executive Summary
The latest regulatory submission news and highlights from our US FDA Performance Tracker.
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Keeping Track: A Busy Week For Regenerative Medicine, A Surprise Priority Review For Vascepa, And Tazemetostat Aims For Accelerated Approval
The latest drug development news and highlights from our US FDA Performance Tracker.
Finance Watch: Opko's Stock Halted As Nasdaq Awaits An Explanation For SEC Pump-And-Dump Lawsuit
Public Company Edition: An SEC complaint alleges that the company, Opko CEO Frost and co-defendants bought penny stocks, pumped up their value, then dumped shares for sizeable profits. Also, Pfizer and Retrophin float debt offerings, while Zealand sells royalties and milestone fees to raise cash.