Thursday, October 18, 2012

Reuters: Global Markets: FDA extends review of Biogen MS drug; shares fall

Reuters: Global Markets
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FDA extends review of Biogen MS drug; shares fall
Oct 18th 2012, 13:07

Thu Oct 18, 2012 9:07am EDT

(Reuters) - Biotechnology company Biogen Idec Inc said U.S. health regulators extended the review date of its multiple sclerosis drug, BG-12, by three months.

Shares of Biogen were down 3 percent at $149.50 in premarket trading.

The U.S. Food and Drug Administration needed additional time to review the application, the company said.

The FDA did not ask for additional studies, Biogen said.

The oral drug, also known as dimethyl fumarate, is currently under review by regulatory authorities in the European Union, Australia, Canada and Switzerland, apart from the United States.

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