FDA Grants Priority Review for Genzyme’s Cerdelga

US regulatory body, the Food and Drug Administration (FDA), have announced that they will be undertaking an accelerated a review of Sanofi’s Genzyme unit’s Gaucher disease drug, Cerdelga (eliglustat), having granted a six-month priority review for the application. Gaucher disease is a genetic disorder where lipids build up in cells and certain organs, causing problems

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Sanofi Announces Positive Phase III TEMSO Results

Sanofi and their subsidiary Genzyme announced the publication of their pivotal Phase III TEMSO (Teriflunomide Multiple Sclerosis Oral) study with investigational once-daily oral medication teriflunomide in The New England Journal of Medicine (NEJM). The results showed that teriflunomide, at the 14mg dosage, significantly reduced the yearly relapse rate, reduced disability progressions and improved numerous magnetic

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