BAFF / APRIL Inhibitors Homing in on IgAN

Today we discuss the group of BAFF/APRIL inhibitors, specifically the three TACI mAb constructs that are currently in development. They were tested in a broad gamut of B-cell indications but failed to show efficacy in many. So far, consistent clinical success has been seen only in IgA nephropathy (IgAN), with Continue reading BAFF / APRIL Inhibitors Homing in on IgAN

THE UTILITY OF FUTILITY

Companies can stop studies before reaching projected enrollment numbers.  It could be a decision based on a planned interim analysis (IA) or it could be for  â€˜administrative’ reasons.  The latter may not indicate that a company has fallen on hard times financially; it could be the result of operational problems Continue reading THE UTILITY OF FUTILITY

Sulopenem uUTI – Does It Suffice?

Sulopenem / ORLYNVAH approved for uUTI When Iterum, a Pfizer spin-off of sorts, took over sulopenem development in 2015, there was still hope for approvals of this drug in multiple indications such as uUTI, cUTI, cIAI and even CABP.  Ten years later and after an FDA rejection CRL in 2021, Continue reading Sulopenem uUTI – Does It Suffice?