PK/PD of BIOLOGICALS

Sometimes we come across an article we wish we had read earlier.  This was the case with the publication by Zhao and colleagues[1].  The article, now more than 12 years old, was written in the ‘early’ days of biological drug development, after the first wave of mAbs had already been Continue reading PK/PD of BIOLOGICALS

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 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