Incyte
NEWS
The U.S. Food and Drug Administration (FDA) had several PDUFA dates on their calendar for the last week of July, but in two cases, there were problems with the submissions ahead of time. Here’s a look.
The Oncologic Drugs Advisory Committee (ODAC), as part of the U.S. Food and Drug Administration (FDA), has voted 13-to-4 against supporting the accelerated approval of Incyte’s PD-1 inhibitor for squamous cell carcinoma.
Incyte had a particularly big week scheduled with the U.S. FDA, which included two PDUFA dates and an advisory committee meeting. In addition, Ascendis had a target action date.
It was another busy week for clinical trial announcement. Here’s a look.
Companies have already begun their announcements of new clinical studies for various treatment settings in preparation for ASCO 2021.
Please check out the biopharma industry’s COVID-19 stories that are trending for April 13, 2021.
It was a relatively quiet week for clinical trial announcements, but there were a few standouts. Read on for more.
Eli Lilly and Company and Incyte announced today that their Phase III COV-BARRIER study of Olumiant (baricitinib) plus standard of care (SoC) compared to placebo plus SoC failed to hit statistical significance against COVID-19 for its primary endpoint.
The action data was extended by the agency to provide more time to review new data analyses submitted by Lilly, per information requests made by the FDA.
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