VRG50635 – Lessons Learned in ALS

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→

Draft FDA Guidance for COCCIDIOIDOMYCOSIS

David Larwood, CEO of VFS, summed it up at the Cocci FDA workshop in 2020: “When the market opportunity is limited, finding investment becomes the key issue”.  He mentioned other problems as well: “Very low patient numbers for disseminated disease, prolonged therapy, NI trial design, definition of clinical outcome”.[1] Clearly, Continue reading Draft FDA Guidance for COCCIDIOIDOMYCOSIS→

Artie’s Law: Avoid Bad Advice and Don’t Follow ‘Mission Impossible’ Advice

In this day and age, few truly broad spectrum antibiotics are in development, although this does not hold true for narrow-spectrums.  Just think of all the MRSA drugs (quinolones, FabI inhibitors), the pseudomonas drugs (NCEs and monoclonals) or some narrow spectrum drugs that will need to be tested in MDR Continue reading Artie’s Law: Avoid Bad Advice and Don’t Follow ‘Mission Impossible’ Advice→