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Merck Gardasil BLA a priority?

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Merck is requesting a priority review for its human papillomavirus vaccine Gardasil (quadrivalent human papillomavirus types 6, 11, 16, 18, recombinant), submitted Dec. 1. If granted a priority review, a June 1, 2006 approval would allow Merck to launch the vaccine before the 2006 back-to-school immunization season. GlaxoSmithKline continues development of its HPV vaccine Cervarix, which it claims offers viral protection against multiple viral strains and in a wider age group than Gardasil (Pharmaceutical Approvals Monthly July 2005, p. 4). GSK said it plans to submit Cervarix in 2006...
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