Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Biogen: US And EU Regulators Accept Plegridy Marketing Applications For Review

RELATED NEWS
Trade BIIB now with 

Biogen Idec (BIIB: Quote) announced Friday that U.S. and EU regulatory authorities have accepted the marketing applications for the review of Plegridy (peginterferon beta-1a), the company's pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis or MS.

The U.S. Food and Drug Administration or FDA has accepted Biogen Idec's Biologics License Application or BLA for marketing approval of Plegridy in the United States and granted the company a standard review timeline. The Marketing Authorisation Application or MAA of Plegridy for review in the European Union was also validated by the European Medicines Agency.

The regulatory applications included positive one-year results from the two-year global Phase 3 Advance study. The data demonstrated that PLEGRIDY met all primary and secondary endpoints by significantly reducing disease activity including relapses, disability progression and brain lesions compared to placebo, and showed favorable safety and tolerability profiles at one year.

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
Oracle Corp. said Wednesday after the markets closed that its second quarter profit fell 2% from last year, hurt mainly by higher income tax expenses even as revenue increased 3%. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations as did its quarterly revenue. Apple's iPhone-based Apple Pay system is gaining momentum nationwide with a host of new banks and retailers signing on. The system allows users to link a credit card directly to their device for payments and Apple now says they have deals with banks that account for 90 percent of the debit card transactions in the US. The current drop in fuel prices could lead to a major sales dip for electric automaker Tesla, according to some industry experts. The Elon Musk led manufacturer had predicted sales of over 500,000 new vehicles by 2020, but now that number could fall by as much as 40 percent.
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.