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GSK Will Answer FDA “Complete Response” Letter For Cervarix In Q2

Executive Summary

GlaxoSmithKline will answer FDA's "complete response" letter for its Cervarix BLA in the second quarter, but the firm expects the product will require advisory committee review for final approval, CEO JP Garnier said during GSK's year-end earnings call

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GSK plans for Avandia rebound: After finalizing the labeling changes for Avandia (rosiglitazone), GlaxoSmithKline is seeking to jumpstart sales of the type 2 diabetes drug, which plummeted in 2006 due to cardiovascular safety concerns. GSK got the best possible label, stating that the risk is "inconclusive" and does not draw a distinction between Avandia and other oral anti-diabetics (1"The Pink Sheet" Nov. 19, 2007, p. 3). "Can we get it back on track? ... The consensus on Avandia is that no, you can't. ... [Financial analysts] expect that we will not be able to restore health on Avandia in the U.S.," outgoing CEO JP Garnier said Jan. 8 at the JPMorgan Healthcare conference. "Well we're going to try to prove that wrong, and we're certainly going to push the drug." He advised investors not to expect an uptick in sales before June or July. "We have to give it the best shot because, frankly, the medicine needs to be used and deserves to be used, and is no different from the rest," Garnier added. "I think we can counter this negative media and very clumsy reporting with facts and data and FDA support"...

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The launch of GlaxoSmithKline human papilloma virus vaccine Cervarix will be further delayed behind Merck's competing Gardasil vaccine after FDA issued a "complete response" letter related to the BLA Dec. 17

Avandia Adds Black Box For Heart Attack Risk; Actos Launches Ads

FDA has unveiled the much-anticipated labeling change for GlaxoSmithKline's type 2 diabetes therapy Avandia, but is deeming the information about rosiglitzone's cardiovascular risk "inconclusive" and is asking the sponsor to undertake a long-term outcomes study to address outstanding safety questions

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