TKT European Company To Be Led By Ex-P&U Genotropin Team
Transkarayotic Therapies' newly established European company will be headed by executives who led the EU and Japan launch of Pharmacia & Upjohn's Genotropin.
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BLA submitted June 16 for Fabry disease enzyme replacement injectable agalsidase alfa based on Phase II data. The biologic has orphan drug designation and will receive priority review
EMEA's Committee for Orphan Medicinal Products expects to deliver its first orphan drug designations by the third quarter of this year, the committee said.
The suspension of Transkaryotic Therapies' gene therapy trial at Beth Israel Deaconess Medical Center could signal the beginning of a trend of gene therapy trial suspensions as a cautionary measure even if the study shows no sign of problems.