Dalbavancin Approval Issues: A Case of Much Ado About Nothing

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” Continue reading Dalbavancin Approval Issues: A Case of Much Ado About Nothing

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

It is a while ago (2006) when TeGenero ran its ill-fated Phase 1 study of TGN-1412, 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 Continue reading Dosis Sola Facit Venenum – The TAB08 (aka TGN1412) Relaunch