Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
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
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?
At the recent FDA workshop on narrow-spectrum antibiotic development[1], the concept of using bacteriological response (BR) as an efficacy endpoint was flat-out rejected. The reason given is the purported lack of correlation between BR and survival/mortality which FDA considers the most important clinical endpoint[2]. FDA felt so strongly about this, Continue reading The Weak Correlation Between Antibiotic Action and Mortality