A Professional Service Provider for the Pharma Industry
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
In a recent blog we took issue with a Nature article about ‘Lessons learned’ after a TIGIT inhibitor failed in late Phase 3 development. We felt that the article provided few insights, mainly platitudes. This week we saw a different kind of post-mortem. It was about VRG50635, a PIKfyve inhibitor Continue reading VRG50635 – Lessons Learned in ALS