TxCell has been cleared to restart a Phase IIb trial of its candidate Crohn’s disease cell therapy by European regulators.
The US FDA was warned CordenPharma about manufacturing operations at a plant in Italy that was approved to make injectable cancer drugs last year.
Indian drugmaker Biocon has been given the go-ahead to expand a biopharmaceutical manufacturing facility in Bangalore.
Celltrion will invest $275m at its biosimilar production site in Korea to ramp up capacity from 140,000L to 310,000L by 2021.
Xellia Pharmaceuticals has started building a stability and release-testing unit at its API facility in Budapest, Hungary that is designed to support increased output.