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.
At Solicitor General’s Urging, Supreme Court May Take Up Patent Eligibility Dispute Riling Biopharma
Federal Circuit’s rulings on subject matter patent eligibility have fractured the court, the US government says in advising the high court to review American Axle v. Neapco to provide clarity. BIO, former PTO director Kappos and Sen. Tillis also urge Supreme Court to hear the case.
Decentralized trials are way to help displaced Ukrainians remain in studies and could encourage greater participation from individuals in other countries, those overseeing sites in Ukraine say.