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Acambis submits smallpox vaccine

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Acambis completes rolling BLA submission for its ACAM2000 smallpox vaccine, the firm says April 18. Assuming a priority review and mid-April submission, the vaccine has a mid-October PDUFA date. Acambis initiated the rolling submission in February (1Pharmaceutical Approvals Monthly February 2006, In Brief). The firm received a $428 mil. U.S. government grant in 2001 for production of the vaccine...

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