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July 2008 Off the Wire . . .

 

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News Article 02raw

Biogen, Elan report brain infections in patients

Story Provided by : Market Watch
Article Date: 31 Jul 2008



Tysabri has been linked to a rare condition called progressive multifocal leukoencephalopathy (PML), where the white matter in the brain becomes inflamed. The drug was taken off the market briefly following its 2004 Food and Drug Administration approval, when it was linked to three deaths from PML.
Tysabri was allowed back on the market in 2006 after no other cases had been identified.
In a regulatory filing late Thursday, Biogen and Elan said they've notified regulatory agencies Friday that they recently received notifications of two diagnoses of PML in multiple sclerosis patients "in the European Union."
The companies said they will host a conference call Friday to discuss the matter.
Biogen and Elan earlier this month announced that Tysabri was being used on more than 31,800 patients as of the end of June, two years after the drug was re-launched following a safety recall. See related story.
Tysabri was withdrawn from the market in Feb. 2005, just three months after its launch in the U.S.
Earlier this week, Elan reported that study results for its Bapineuzumab Alzheimer's disease drug provided mixed results, sending its shares sharply lower.

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