GSK, Theravance withdraw Relvar license application in Japan
The companies have decided to pull the application as no Japanese patients were included in two longer 52-week exacerbation studies of FF/VI and the six-month clinical data on
Swedish Orphan Biovitrum (Sobi) has received a complete response letter from the US Food and Drug Administration (FDA) regarding its biologics licence application for nanoencapsulated sirolimus plus pegadricase (NASP), an investigational therapy intended for adults with uncontrolled gout.
Simplifying testing and increasing performance of the process, the new capsules remove the need for costly, incompetent pooling of multiple batches for primary separations/prefiltration, secondary clarification, cell culture