A regulatory framework that encourages physicians to conduct experimental cell and gene therapies have propelled China to become a major developer of such promising cancer-treating tools, but insiders say three are a plethora issues at stake.

The first of around 260 patients for a clinical trial comparing its PB006 natalizumab biosimilar candidate to Biogen’s Tysabri reference brand have been recruited by Polpharma Biologics, which has just added Karsten Roth and Alexandra Moulson to its team.

How do notified bodies ensure that their personnel, and the teams they allocate for conformity assessment of medical devices, have the precise knowledge and expertise needed? A new EU document gives guidance on this.