Executive Summary

GlaxoSmithKline's BLA for Cervarix gets 10-month standard review, setting a January 2008 user fee date for the human papilloma virus vaccine. The firm submitted the vaccine March 29 with a request for a priority review (1Pharmaceutical Approvals Monthly April 2007, In Brief). The decision gives Merck additional time to establish Gardasil, which launched 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 (2Pharmaceutical Approvals Monthly February 2007, p. 21). In April, Merck submitted an sBLA seeking additional claims for Gardasil for protection against vaginal and vulvar cancers...