As a part of real-world evidence, patient-reported outcomes can serve to evaluate a drug's efficacy against primary or secondary endpoints and also reflect safety and quality of life, notes a just-released draft regulation from China’s Center for Drug Evaluation.

GSK could soon see an approval in Japan for its antibody therapy following a filing for emergency use, while South Korea looks to build its mRNA vaccine capabilities through a new consortium. 

In this week's podcast edition of Scrip's Five Must-Know Things: US industry warns over pricing; a setback for another gene therapy; a Phase II disappointment for Novartis; Actemra shortages cause CAR-T worries; and Sweden's Sobi set to go private.