BioCentury on BioBusiness,
Politics and Policy
Tropical disease: Novartis shows FDA will honor vouchers; value still unclear
Tweaking PRVs
By Steve Usdin
Washington Editor
Published on
Monday, August 8, 2011
When Congress created the
Priority Review voucher program in 2007, no one knew whether or how the reward
scheme would succeed in stimulating the development of new therapies for
neglected tropical diseases. Now a critical question - whether FDA will honor
vouchers as Congress intended - has been answered affirmatively.
During the June 21 meeting of the Arthritis Advisory
Committee, an FDA official revealed the sBLA for Ilaris canakinumab had been
escalated from a standard to a priority review because Novartis
AG had used a PRV to upgrade the review path.
91
words displayed of
1302
words total.
To read this article, you must be an Archives subscriber. Please choose one of the options below.
All contents Copyright © 1993-2013 BioCentury Publications, Inc. ALL RIGHTS RESERVED. All use of this Web Site and its contents is governed by the BioCentury User Agreement and the BioCentury Terms of Use. The contents of this Web Site are protected under U.S. and foreign copyright and intellectual property laws, and no part of this Web Site or its contents may be photocopied, reproduced or retransmitted in any form without the written consent of BioCentury, which may be requested from Reprints/Permissions at www.biocentury.com. BioCentury®; The Bernstein Report on BioBusiness™; The BioCentury 100™; The Clear Route to ROI™; Because Real Intelligence is Hard to Find™; BCIQ™; and BioPharma's Knowledge Center™; are trademarks of BioCentury Publications, Inc., P.O. Box 1246, San Carlos, CA 94070. SciBX® and SciBX: Science-Business eXchange® are trademarks of Nature America, Inc. that are jointly used by BioCentury Publications, Inc. and Nature America, Inc.
|
Current Subscribers
If you are a current subscriber, log in below or in the upper right corner of this
page.
Log In
Subscription Option
Whether you want an individual subscription or need a global group license, we have the products,
the experience and the customer support that biopharma executives, researchers, investors, service providers,
and industry stakeholders have trusted for nearly two decades.
Let our Subscriber Services team customize the best intelligence package available in the industry to meet your needs.
Free Trial 4 Weeks of Access
Get a 4-week free trial subscription to see the important articles you are missing.
Get 4 Weeks Free
Thank You
Thanks for purchasing this article.
Please bookmark this url for future reference.
We have also sent you a confirming e-mail with a receipt and this same url for your
records.
close [ X ]