A Professional Service Provider for the Pharma Industry
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
In 1886, Weil published detailed case descriptions of 4 patients with icterus, splenic enlargement and nephritis [1]. All four patients presented with acute onset of fever, elevated liver function tests (LFTs), hepatic enlargement, splenomegaly, and proteinuria. Two cases were recorded more than12 years earlier, but the author felt that they Continue reading On Leptospirosis (Weil’s Disease)