Plus deals involving Zai Lab/Karuna, Zai Lab/Blueprint, Lotus/PharmaMar, Nippon Shinyaku/Dynacure, Alphamab/Ascletis, Aptose/Hanmi, Shanghai Pharmaceuticals/HUYABIO, KoBioLabs/SPH Sine, CURACLE/ Théa Open Innovation, Signet/XtalPi, Curi Bio/NEXEL, CANbridge/Scriptr and Ligand/CRDC.

Pfizer-funded systematic review of approved oncology applications that contained RWE highlights common deficiencies flagged by FDA and says strength of trial data is a key determinant of the extent to which RWE is needed and considered by the agency.

A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval. 

Sponsors of several new medicines are set to learn if their products are on track for pan-EU approval. One product on the list is Pfizer/Lilly’s osteoarthritis drug, tanezumab, which recently ran into trouble in the US.