An advisory committee has recommended approval of Retacrit in the US after Pfizer addressed manufacturing and clinical concerns from its first submission in 2015.
The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.
Sartorius’ third acquisition in the bioanalysis space in the past year will add Essen BioScience’s real-time live-cell analysis platform to its portfolio.