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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Acambis smallpox vaccine rolling BLA
Acambis has initiated a rolling BLA for its cell culture-based smallpox vaccine ACAM2000, with plans to complete the submission this April, the firm announces Jan. 18. Based on the vaccine's fast-track status, Acambis hopes to receive a decision "before the end of the year." Acambis received an HHS grant worth $428 mil. in 2001 to produce 155 mil. doses of the vaccine; the firm said it has delivered 182.5 mil. doses to the U.S. government for stockpiling. The firm's clinical program included 3,800 subjects...
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