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

Novartis' Gilenia Extension Trial Data Support Efficacy Of Low-Dose Version

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

New data on Novartis' investigational oral multiple sclerosis therapy Gilenia (fingolimod) strengthened the efficacy profile of the low dose 0.5 mg version of the drug and highlighted potential benefits of switching from Biogen Idec's Avonex (interferon beta-1a)

You may also be interested in...



Novartis Talking About Fingolimod Safety With FDA; Will Talk To Advisory Panel In June

Structure of the REMS for oral multiple sclerosis drug Gilenia likely to be discussed at committee meeting close to review deadline.

Acorda's Novel Primary Endpoint For Ampyra Was Made Possible By A Supporting Scaffolding Of Secondary Analyses

Secondary analyses in the pivotal trials of Acorda’s Ampyra (dalfampridine) were of front-line interest to FDA as the agency grappled with the first indication for improving walking ability in multiple sclerosis patients and an untested primary endpoint.

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

PS004436

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