Cancer Vaccines
GlaxoSmithKline Submits Biologics License Application to U.S. Food and Drug Administration for CERVARIX
Published in Vaccine Weekly, April 18th, 2007
GlaxoSmithKline (NYSE:GSK) announced that the company has submitted a Biologics License Application (BLA) for CERVARIX(R) (human papillomavirus vaccine, AS04 adjuvant-adsorbed), its cervical cancer candidate vaccine, to the U.S. Food and Drug Administration (FDA). If licensed, the vaccine will be indicated for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus types. For this candidate vaccine, GSK selected a novel proprietary adjuvant system called AS04, intended to enhance immune response and increase duration of protection.
"Today's filing is an important milestone for GSK and reflects our...
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Source: Vaccine Weekly (2007-04-18)
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