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Same-Day BLA Filings Show Pfizer Has Gained Ground On Novartis In Meningitis B

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Both companies have “breakthrough” therapy designations from FDA and both announced BLA filings on June 17, but Pfizer’s earlier completion of the rolling submission could give it an edge in the race to launch a meningitis B vaccine in the U.S.

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