Conspiracy Theory Posited Over Shire’s Withdrawal Of BLA For Fabry Disease Drug
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
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.
Novartis co-leads industry forum on preapproval access that aims to share best practices and engage patient groups; Janssen is launching three pilots to leverage collection of preapproval access data.
FDA is worried about drug names that could appear to overstate efficacy and impact consumer and healthcare provider perceptions of the product.