Acambis smallpox vaccine rolling BLA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
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...