Cole Werble
GlaxoSmithKline PLC no longer expects the human papilloma virus vaccine Cervarix to enter the US market in 2008.
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Cervarix Delayed: Setback for GSK is Opportunity for FDA to Create New Model for Adjuvant Approvals
GSK's Cervarix HPV vaccine is going to miss another back-to-school vaccination season in the US, giving Merck even more time to cement its lead with Gardasil. The delay surprised Wall Street-but shouldn't have. FDA is exercising caution about the approval of a second HPV vaccine - one containing a new active adjuvant. The final approval will set new standards for the coming wave of adjuvant-enhanced vaccines.
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