Genzyme Plant Cleanup Brings Temporary Halt To Fabrazyme, Cerezyme Production
This article was originally published in The Pink Sheet Daily
Executive SummaryPlagued by a virus, the biotech hopes to have Allston Landing facility back in operation by late July, but warns of short-term drug shortages.
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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.”
Distributed free of charge to U.S. patients with Genzyme’s Fabrazyme in short supply, Replagal seemed destined for quick approval, but FDA has signalled otherwise.
Replagal seemed destined for quick approval – the enzyme replacement therapy was already distributed free of charge to U.S. patients in response to short supples of Genzyme’s Fabrazyme. But FDA has signaled otherwise, and Shire doesn’t think Replagal warrants the effort.