12:00 AM
Aug 06, 2007
 |  BioCentury  |  Regulation

Question time

Question time

Question time
Of the set of eight questions prepared for last week's FDA advisory panel on Tysabri from Elan (ELN) and Biogen Idec (BIIB), only the first part of Question 8 was actually resolved during the meeting. The panel agreed Tysabri should be made available to patients with moderate to severe Crohn's disease who have failed or are unable to tolerate available therapies, and voted 12-3, with two abstentions, that FDA approve the treatment assuming an effective risk management plan is in place, including post-marketing surveillance...

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