FDA approves new Genzyme plant for Fabrazyme

Genzyme Corp. said FDA approved its Framingham, Mass., manufacturing facility for the production of Fabry's disease therapy Fabrazyme agalsidase beta. FDA's approval follows EMA's approval of the facility last week. The company said the approvals will allow patients in Europe to start returning to full Fabrazyme dosing this quarter, with patients in the U.S. returning to full dosing starting in March (see BioCentury Extra, Jan. 18). ...