Positive outcomes from a multiregional Phase III trial provide Jiangsu Hengrui Medicine with a milestone in the Chinese firm's quest for globalization, as it looks to succeed where others have had recent setbacks.

In this week's podcast version of Five Must-Know Things: Pfizer to boost migraine presence via M&A; Roche’s immunotherapy ambitions take a hit; Biogen’s CEO search gets more complicated; Stoffels lays out new strategy for Galapagos; and mixed results for Japanese majors.

CDER turned in its 13th novel approval of 2022 on Friday the 13th, and other drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

House Appropriations and Energy and Commerce subcommittees will ask about Abbott Nutrition’s recall of infant formula made at its Sturgis, MI, facility. “We are doing everything in our power to ensure there is adequate product available where and when they need it,” says FDA Commissioner Robert Califf.