Differentiation Will Be Key Challenge For Shire's Gaucher Disease Drug Vpriv
The FDA approval of Shire's Vpriv (velaglucerase) means that Genzyme's Cerezyme (imiglucerase) finally has competition in the Gaucher disease space. But market analysts are strongly divided on whether velaglucerase or a pending Pfizer/Protalix drug will be better positioned to make a dent in Cerezyme's market share
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Cerdelga Becomes First Oral First-Line Therapy For Gaucher Disease
Sanofi’s Genzyme unit obtains U.S. approval for eliglustat as an oral, first-line therapy for adults with Type 1 Gaucher disease. The new product will augment its market-leading Cerezyme, and the company says it will price Cerdelga at par so that patient/physician choice will not be based upon price.
FDA Shortage Notification Mandate May Not Extend To Biologics
The agency has the option to issue regulations requiring biologics manufacturers to notify FDA of emerging production problems, but so far it’s only “something that we’re thinking about.”
CSL Behring's Corifact Clears FDA On 14-Patient Trial
The orphan drug, for a rare blood disorder, is the latest in a history of drugs for ultra-orphan conditions.