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GlaxoSmithKline Looks To Revamp U.S. Operations In Tough Environment

This article was originally published in The Pink Sheet Daily

Executive Summary

U.S. sales fell 13 percent in the third quarter due to generic competition and Avandia.

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Cervarix, Gardasil Set For FDA Advisory Committee Review

GlaxoSmithKline knew it was in for scrutiny of its novel AS04 adjuvant, but review of Merck's application to make Gardasil gender-neutral could offer backdoor to re-examine the HPV vaccine's safety record.

Cervarix, Gardasil Set For FDA Advisory Committee Review

GlaxoSmithKline knew it was in for scrutiny of its novel AS04 adjuvant, but review of Merck's application to make Gardasil gender-neutral could offer backdoor to re-examine the HPV vaccine's safety record.

GSK resubmits BLA for Cervarix

Finally responding to a December 2007 "complete response" letter from FDA, GlaxoSmithKline has re-filed its BLA for Cervarix, its vaccine to prevent cervical cancer and pre-cancer related to human papillomavirus types 16 and 18. Cervarix is approved in Europe and is the market leader in the U.K., ahead of Merck's competing vaccine, Gardasil. GSK's new filing, announced March 30, includes final data from the pivotal HPV-008 study - the previous BLA was based upon interim data. Also holding up FDA approval was the fact that the vaccine uses an adjuvant that is new and has a new active ingredient for which the agency had no regulatory framework (1"The Pink Sheet" DAILY, Oct. 22, 2008)

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