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 ...

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 ...

Also Read: Sanofi Genzyme Facility Draws FDA Criticism Over Alleged Quality Lapses An independent data monitoring committee (IDMC) conducted a scheduled review of the E.mbrace phase 3 study. The ...

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.

But the Genzyme shareholders said Sanofi slowed development ... In Lemtrada’s case payouts were cut because of an initial FDA rejection, and eventual approval in 2014, several months too late ...

that could have been worth as much as $14 each—$3.8 billion total—if Genzyme’s Lemtrada drug, still in development, received U.S. Food and Drug Administration (FDA) approval and hit ...

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 ...

Fabry Disease Clinical Trial Pipeline Major pharmaceutical companies are working to advance the pipeline space and unlock the future growth ...

Also Read: Sanofi Genzyme Facility Draws FDA Criticism Over Alleged Quality Lapses An independent data monitoring committee (IDMC) conducted a scheduled review of the E.mbrace phase 3 study.