First European Cell Therapy Is Commercial Flop
The first cell-based product to be approved in Europe, the TiGenix-developed and Sobi-marketed ChondroCelect, has met an ignominious end with the withdrawal of its marketing authorization. However, TiGenix has entered into an agreement with Takeda for ex-US rights to its next product candidate.
You may also be interested in...
German company CO.DON is celebrating the fact that it probably won’t be long before it can start selling across Europe its key product – an advanced therapy for the repair of certain cartilage defects of the knee that’s been in use in Germany for ten years.
Advocacy group Alliance for Regenerative Medicines has called for urgent fixes to the hospital exemption scheme under the EU Advanced Therapy Medicinal Products Regulation to ensure the provision is not misused to by-pass strict marketing authorization requirements.