CSL plans flu vaccine BLA by 2007
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
CSL plans to submit a BLA "within 12 months for both multi-dose vial and thimerosal-free single-dose" formulations of an influenza vaccine, the Australian firm announces Feb. 7. A clinical study is slated to begin "later this year." An early 2007 submission could put the CSL flu vaccine on the U.S. market in time for the 2007-2008 season; the firm plans to supply "up to 20 mil. doses to the U.S. as the expanded plant comes online in 2008," CSL says. The company has manufactured flu vaccine in its Melbourne facility since 1968...