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

Gilenia's Risk Management Should Key On Initial Doctor Visit, Cmte. Says

Executive Summary

Novartis' Risk Evaluation and Mitigation Strategy for Gilenia (fingolimod) may need to include more explicit testing requirements instead of just the physician and patient education programs that the firm has proposed

You may also be interested in...



“Defensive REMS” May Be Needed To Appease Advisory Committees

Sponsors facing an FDA advisory committee should be prepared to discuss Risk Evaluation and Mitigation Strategies, even if FDA tells a company that a REMS need only have minimal elements or is not necessary, to avoid a negative vote, industry experts say.

“Defensive REMS” May Be Needed To Appease Advisory Committees

Sponsors facing an FDA advisory committee should be prepared to discuss Risk Evaluation and Mitigation Strategies, even if FDA tells a company that a REMS need only have minimal elements or is not necessary, to avoid a negative vote, industry experts say.

Novartis' Gilenya: Efficacy, Patient Assistance Lie At Heart Of Marketing Push

As Novartis' multiple sclerosis treatment Gilenya (fingolimod) hits the market, the company is hoping to move beyond the fact that the drug is the first-ever oral drug for general treatment for the disease and highlight its clinical efficacy compared with other MS drugs.

Related Content

Topics

UsernamePublicRestriction

Register

PS052323

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