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


Legacy Cost: Takeda’s Entyvio Development Shaped By Tysabri Fallout

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The specter of Tysabri and its restrictive REMS loomed over the review of Takeda’s Entyvio, making for an unusually high level of communication and discussion from Phase II until late in the review cycle – a tally that includes 14 pre-BLA face-to-face meetings between FDA and the sponsor, as well as two advisory committee reviews and two turns before FDA’s REMS Oversight Committee.


Related Content


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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