Genzyme said in a Sanofi statement it had received an FDA 'complete response letter', to which it would appeal. Its president and chief executive was " extremely disappointed with the outcome of ...

Genzyme ran into a snag in April when the US Food and Drug Administration (FDA) rejected its application to produce Myozyme (alglucosidase alfa, rhGAA) in its 2,000–liter-scale facility under ...

Sanofi unit Genzyme has fallen foul of the Association of the British Pharmaceutical Industry's Code of Practice over claims that switching patients to its Fabry disease therapy Fabrazyme from ...

What's more, FDA and Health Canada have granted expanded ... know the differences between stem cell products,” he says. Genzyme and Osiris' partnership hinges heavily on Prochymal (Nat.

Genzyme Approved by US FDA Stem cell mobilizer Use in combination with G-CSF AMD070 Genzyme Suspended (Phase I/II) HIV A derivative of AMD3100 that can be orally administered. Liver histology ...

Chesbrough, Henry W., and Clarissa Ceruti. "Genzyme: Engineering the Market for Orphan Drugs." Harvard Business School Case 602-147, March 2002. (Revised May 2002.) ...

In May 2020, the companies filed an application with the U.S. Food and Drug Administration (FDA) seeking the accelerated approval of PRX-102, given at a dose of 1 mg/kg every other week ...