Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Shire Submits Elaprase BLA For Hunter Syndrome

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Shire's Elaprase (idursulfase) could be approved as early as May 2006 for Hunter syndrome if FDA grants the company's request for priority review of the BLA submission, announced Nov. 24

You may also be interested in...



Shire/TKT I2S Hunter Syndrome BLA, MAA Slated For Fourth Quarter

Transkaryotic Therapies is planning a fourth-quarter BLA submission for its Hunter syndrome enzyme replacement therapy I2S, the firm said June 20

Licensing In Brief

Shire addition of European rights to Dynepo is key driver of $1.6 bil. TKT merger. Roche’s Xenical to be detailed by GSK. Schering-Plough to out-license U.S. rights to Phase III quinolone antibiotic garenoxacin. Kos plans Teveten and Cardizem LA re-launch in June following purchase/licensing pact with Biovail. More licensing deals in brief

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS003155

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