J.P. Morgan Notebook Day 1: PCSK9 Face-Off, Teva's Slowed Growth, Merck's Keytruda Wins, Lilly's CDK4/6 Hopes And More

J.P. Morgan Notebook Day 1: PCSK9 Face-Off, Teva's Slowed Growth, Merck's Keytruda Wins, Lilly's CDK4/6 Hopes And More

January 10, 2017, The Pink Sheet

Wade Ackerman participated at the Biotech Showcase and is quoted by The Pink Sheet in an article regarding the increased use of real-world evidence by FDA following the passage of the 21st Century Cures Act. According to Ackerman, FDA will be running a pilot program to evaluate the potential of real-world evidence to support supplemental indications and satisfy post-approval safety requirements, which creates a great opportunity depending on a company's product areas, particularly when it comes to unmet needs and drugs for rare diseases. "There is a lot of gray in this area," Ackerman adds, but FDA appears eager "to find different sponsors to work with to really move this forward."