Keeping Track: Biosimilar Submissions Galore (And An Approval), Bayer Gets An Oncology Approval, KemPharm Resubmits Apadaz NDA
The latest regulatory submission news and highlights from our US FDA Performance Tracker.
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Changing therapeutic landscape may have complicated regulatory plans for Regeneron/Sanofi’s PD-1 inhibitor in second-line cervical cancer, while accelerated approval confirmatory trial timeline appears to have been an issue for Incyte’s PI3-kinase inhibitor in lymphoma.
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.
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.