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

Pre-market Movers For May 13 (BIIB, THRX, PERI, TSLA, ENDP, ASIA, WSB, CITZ)

Correction: Biogen Idec Says FDA Accepts BLA For Marketing Approval Of ELOCTATE

Biogen Idec Inc. (BIIB) Has Set A New High For The Year

Biogen Idec Q1 13 Earnings Conference Call At 8:00 AM ET

Trade BIIB now with

2/28/2012 8:13 AM ET

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

<<Previous 112 Articles

Editors Pick

Stocks May Show A Lack Of Direction In Early Trading - U.S. Commentary

After turning in a lackluster performance throughout the previous session, stocks may continue to experience choppy trading on Tuesday. The major index futures are currently pointing to a roughly flat open for the markets.

U.K. Inflation Eases To 7-Month Low

U.K. consumer price inflation slowed more-than-expected to a seven-month low in April on falling petrol and air fares, official data revealed Tuesday. The slowdown provides relief for consumers as it raises purchasing power, while it gives more scope for the central bank to ease monetary policy.

Obama To Deliver Speech On Counterterrorism Policies, Use Of Drones

President Barack Obama reportedly plans to deliver a much-anticipated speech on Thursday outlining his administration's evolving counterterrorism policies. Multiple news sources cited a White House official as saying that Obama will address the use of drones and plans to close the detention facility at Guantanamo Bay in a speech at the National Defense University.