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Tysabri Return Depends On Patient Group Input, CDER Deputy Says

Executive Summary

FDA will rely on the input of multiple sclerosis patient organizations to help determine the status of Biogen Idec/Elan's Tysabri, Center for Drug Evaluation & Research Acting Deputy Director Douglas Throckmorton told the Stanford Washington Research Group conference May 5

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Tysabri Re-Entry Hinges On Effective Risk Management: Diagnostics May Be Key

Any risk management program tied to the market re-entry of Biogen Idec/Elan's Tysabri would likely include diagnostic procedures to test for early signs of progressive multifocal leukoencephalopathy

Tysabri Re-Entry Hinges On Effective Risk Management: Diagnostics May Be Key

Any risk management program tied to the market re-entry of Biogen Idec/Elan's Tysabri would likely include diagnostic procedures to test for early signs of progressive multifocal leukoencephalopathy

Tysabri feels the heat

Safety evaluation of patients taking Biogen Idec/Elan's multiple sclerosis product Tysabri (natalizumab) remains on track to be completed by "late summer," Elan says. Following a Boston Globe report of a potential fourth case of progressive multifocal leukoencephalopathy, Elan emphasized that there have been only three confirmed cases and two fatalities. In May, FDA said that it will weigh the opinion of patient groups in deciding whether Tysabri should return to market (1"The Pink Sheet" May 16, 2005, p. 12)...

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