Tag Archives: TGN-1412

Dalbavancin Approval Issues: A Case of Much Ado About Nothing

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Dalbavancin has changed hands a few times in its development history, moving from Lilly to Vicuron, then Pfizer and ultimately Durata. The original NDA for dalbavancin was submitted to FDA on Dec. 21, 2004.  Pfizer acquired dalbavancin as a “Phase 3 completed” drug ready for world-wide marketing on June 15, 2005. The Continue reading Dalbavancin Approval Issues: A Case of Much Ado About Nothing→

Dosis Sola Facit Venenum – The TAB08 (aka TGN1412) Relaunch

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It is a while ago (2006) when TeGenero ran its ill-fated Phase 1 study of TGN1412, a CD28 superagonist slated for studies in diseases like rheumatoid arthritis and B-cell CLL. Unexpectedly, in this FIM study, TGN1412 generated a cytokine release syndrome (CRS), some called it “cytokine storm”, a massive T-cell Continue reading Dosis Sola Facit Venenum – The TAB08 (aka TGN1412) Relaunch→