FDA office rebukes plans to track Tysabri

The FDA's Office of Drug Safety has criticized plans by Biogen Idec and Elan to monitor the health of patients taking Tysabri if they get approval to relaunch the MS therapy. The office criticized the drug developers' plans for a voluntary registry, saying it doesn't adequately address the risk of PML, a rare brain disease linked to patients taking Tysabri. Analysts, though, say all the signs still point to the FDA's agreement to allow Tysabri to return. An agency review of Tysabri started today.

- read this article from the Boston Globe

ALSO: Trading of Elan shares was suspended pending an announcement on Tysabri. Report