Biogen Idec Reports First Tysabri PML Case In U.S.
This article was originally published in The Pink Sheet Daily
Executive Summary
Report is “not unexpected,” FDA says, but adverse event is not yet a non-event for Biogen and Elan.
You may also be interested in...
Tysabri Sales Dip But Don’t Swoon After PML Adverse Events
Biogen plans to report further progressive multifocal leukoencephalopathy cases only when “they provide substantial new information,” CEO Mullen says.
Safety Panic: Tysabri, Byetta and the Challenge of Risk Communication on Wall Street
There is no question someone is over-reacting to safety issues with Biogen Idec/Elan's Tysabri and Lilly/Amylin's Byetta. But is it FDA-or investors?
FDA Still Behind Tysabri Monotherapy
Medwatch warning is less strident than some feared.