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Tysabri Could Return In Fall; Marketing Suspended By Biogen Idec And Elan

This article was originally published in The Pink Sheet Daily

Executive Summary

One fatal, confirmed case of progressive multifocal leukoencephalopathy and one suspected case prompt withdrawal of multiple sclerosis product; risk/benefit ratio needs to be reestablished, companies say. Return to market would not be unprecedented, but Tysabri’s withdrawal sharpens focus on FDA's drug safety oversight.

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Company reluctantly agrees to FDA’s request to suspend sales of ponatinib due to serious thrombotic risks while a narrower label and Risk Evaluation and Mitigation Strategy are negotiated. FDA cites serious adverse vascular event rates of 48% and 24% in Phase I and II ponatinib trials, respectively.

Can Iclusig Return To Market? Ariad Sees Path Through Restricted Distribution REMS

Company reluctantly agrees to FDA’s request to suspend sales of ponatinib due to serious thrombotic risks while a narrower label and Risk Evaluation and Mitigation Strategy are negotiated. FDA cites serious adverse vascular event rates of 48% and 24% in Phase I and II ponatinib trials, respectively.

FDA/EMA/Industry Action On PML Heralds New Foray Into Collaboration

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