FDA denies priority review for Cervarix

GlaxoSmithKline's BLA for Cervarix gets 10-month standard review, setting a January 2008 user fee date for the human papilloma virus vaccine, which was submitted March 29. The decision gives Merck additional time to establish Gardasil, which began sales in June 2006, as the only vaccine on the market to prevent human papilloma virus infection and associated diseases, such as cervical cancer. GSK hopes to position Cervarix as a superior product; a head-to-head trial comparing Cervarix to Gardasil is ongoing (1"The Pink Sheet" April 2, 2007, In Brief)...