Eli Lilly and Company (LLY) and Incyte (INCY) announced that, after discussions with the U.S. Food and Drug Administration (FDA) in late August, Lilly will resubmit the New Drug Application (NDA) for baricitinib before the end of January 2018.
That was fast, we mean the re-submission. To remind you, the firms had submitted Baricitinib for review seeking marketing approval for rheumatoid arthritis in the U.S., the European Union and Japan in 2016. In February 2017, the drug was approved in the EU. In Japan it was approved in July 2017 . . .
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Today’s Highlights August 30, 2017