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
Businessman David Perdue narrowly defeated eleven-term Congressman Jack Kingston, R-Ga., in a runoff for the Republican Senate nomination in Georgia on Tuesday. With all precincts reporting, unofficial results show Perdue with a slim 50.9 percent to 49.1 percent lead over Kingston. Stocks are turning in a lackluster performance in early trading on Wednesday after moving mostly higher over the course of the previous session. The major averages are showing only modest moves, although the S&P 500 did manage to reach a new record intraday high. Bank of England Governor Mark Carney said on Wednesday that interest rate will have to start rising to maintain price stability as the economy normalizes. "As the economy normalizes, Bank Rate will need to start to rise in order to achieve the inflation target," Carney said in a speech in Glasgow, Scotland.
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.