Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Biogen Seeks FDA Nod For Oral BG-12 To Treat Multiple Sclerosis - Quick Facts

RELATED NEWS
Trade BIIB now with 

Biogen Idec (BIIB: Quote) said it has submitted a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or FDA, for marketing approval of BG-12 (dimethyl fumarate), the company's oral therapeutic candidate for the treatment of multiple sclerosis, or MS.

The company stated that the regulatory submission was based on BG-12's comprehensive development program, in which BG-12 demonstrated significant reductions in MS disease activity coupled with favorable safety and tolerability in the Phase 3 DEFINE and CONFIRM studies.

Biogen noted that it intends to submit a Marketing Authorisation Application for BG-12 to the European Medicines Agency within the coming days.

Click here to receive FREE breaking news email alerts for Biogen Idec and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Stocks moved notably higher over the course of the trading day on Friday after initially showing a lack of direction. The gains on the day extended the recent upward trend by the markets, with the tech-heavy Nasdaq reaching its best closing level in almost a month. Looking to capitalize on news of an Ebola diagnosis in New York City, Republican Senate candidate Scott Brown issued a statement Friday criticizing his Democratic opponent Sen. Jeanne Shaheen, D-N.H., for "waffling" on a travel ban. In another troubling sign for Democrats, the results of a Gallup poll released on Friday show that Tea Party Republicans are much more motivated to vote in the upcoming midterm elections than other Americans. The poll found that 73 percent of Tea Party Republicans are "extremely" or "very" motivated to vote in this year's elections.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.