Wyeth Launch Of Effexor Follow-On May Await Low-Dose Data
Executive Summary
Wyeth may postpone launch of its investigational antidepressant DVS-233 (desvenlafaxine extended release) while it collects data on a lower dose of the Effexor follow-on, pending the resolution of manufacturing issues
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JPMorgan Healthcare Conference In Brief
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"...
JPMorgan Healthcare Conference In Brief
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"...
Tablet & Teva Block Sun As Generic Competition For Wyeth’s Effexor XR
Wyeth is anticipating it will be able to block entry of Sun Pharmaceuticals' generic version of Effexor XR because of the brand firm's existing deal with first-to-file Teva and the alternate venlafaxine dosage form that Sun is using in its ANDA