Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Conspiracy Theory Posited Over Shire’s Withdrawal Of BLA For Fabry Disease Drug

This article was originally published in The Pink Sheet Daily

Executive Summary

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...



Shire Withdraws Replagal BLA Rather Than Conduct Lengthy Trials – Updated

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.

Ukraine War Could Spur Changes In The Clinical Trial Paradigm

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.

Topics

Related Companies

UsernamePublicRestriction

Register

PS077438

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel