Shire Withdraws Replagal BLA Rather Than Conduct Lengthy Trials – Updated
This article was originally published in The Pink Sheet Daily
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.
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Knowledge Ecology International suggests Shire pulled its Replagal BLA in return for rights to Mount Sinai School of Medicine patent that could have blocked sales in Europe; asks FTC to investigate “possible conspiracy” between school, Shire and Sanofi.
FDA has signaled that it will re-form its Pharmacy Compounding Drugs Advisory Committee, which was dissolved in 2002, as it deals with an ongoing meningitis outbreak related to compounded steroid injections. 2012 proved to be another busy year for the Oncologic Drugs Advisory Committee, but the full drug safety/risk management panel saw a significantly lighter workload than in recent years.
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.”