Regulatory Roundup: Top News Stories – Week Ending September 29, 2017

The FDA approved Eli Lilly’s Verzenio (abemaciclib) to treat adult patients who breast cancer that has progressed following prior treatment: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm578071.htm Allergan received a refuse-to-file letter from the FDA for its sNDA to add an additional indication to its already-approved drug Vraylar (cariprazine). http://www.biopharmadive.com/news/allergan-hit-with-fda-refusal-to-file-letter/505726/ Janssen received a complete response letter from the FDA for its[…]