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Amevive “complete response” letter

Executive Summary

Biogen receives "complete response" letter for its antipsoriatic therapy Amevive (alefacept) on June 6. The letter asks for further "clarification and information" related to Amevive data already submitted by Biogen. Firm will not be required to conduct additional studies for approval, despite request for additional examination of Amevive safety profile in multi-cycle therapy by an FDA advisory committee. The committee voted 8-2 with one abstention for approval in moderate to severe psoriasis May 23 (1"The Pink Sheet" June 3, p. 22)...

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