Location, Location, Location: Will Sorrento’s China-Only NSCLC Data Fly With US FDA?
Executive Summary
Sorrento plans to meet with the US FDA regarding abivertinib, but the agency’s tough stance on drug approvals based on single-country studies could thwart the company’s efforts.
You may also be interested in...
Geron’s Imetelstat Faces Full Gamut Of US FDA Questions At ODAC Meeting
FDA has efficacy and safety concerns about the proposed anemia treatment and questions whether the results could even apply to US patients given the large number of ex-US study participants.
Go Global Or Stay Home? Geopolitics, Funding Crunch May Force China Biotechs To Choose
Having been used to navigating the Pacific with few obstacles, biotech companies taking advantage of Chinese resources and US innovation now face ballooning tensions between the two countries, which along with narrowing funding channels will increasingly force them to decide where to place their bets in the world’s largest economies.
Payers, Medical Journals Could Help Push For Clinical Trial Diversity, Cavazzoni Says
The director of the US FDA’s Center for Drug Evaluation and Research acknowledged that the FDA cannot improve trial diversity alone.