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U.S. Tysabri Labeling Updated With More PML Risk Info But No Reference To JCV Testing

This article was originally published in The Pink Sheet Daily

Executive Summary

Partners Biogen Idec and Elan had asked both European and U.S. regulators to update the label to include the addition of anti-JC virus antibody status as a risk factor, but so far only the EU has moved toward JCV testing.

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