A Professional Service Provider for the Pharma Industry
It’s not clear whether or not Zuckerman and Powers just want to be provocative or actually believe what they write.[1] Let’s start by stating the obvious: Truth be told, we are lucky to have a good number of antibiotics that still work well for most patients, esp. in outpatient care. Continue reading Misguided Populist Advice
Earlier this year, the NEJM published interim data on atacicept and sibeprenlimab in IgAN, both well-designed Phase 3 pivotal registration trials of promising drugs [1],[2]. Sponsors were clearly anxious to show the world how well their drug is working, but why publish interim results? After all, IA data are usually Continue reading IgAN Therapy – It’s Getting Crowded Out There
The Tavneos story is getting more bizarre by the day: since January 2026 FDA is haggling with Amgen about a withdrawal. The Agency’s reasoning is described in detail in their April 26 statement and mentioned in numerous Pharma newsletters. The key issue is and was the unblinded re-adjudication of the Continue reading The Never-Ending TAVNEOS Story