Omissions – Commissions – Errors – Blunders – Solithromycin

Cempra received a complete response letter (CRL) as a X-mas present from FDA, and the news was pretty bad for company investors. Bad, but not totally unexpected after the AMDAC meeting last November, which taught us a few new things Continue reading Omissions – Commissions – Errors – Blunders – Solithromycin

Profiling Solithromycin: FDA AMDAC on Solithera

Police profiling based on race, sex or gender is a highly controversial practice. FDA doing the same, not so much. Profiling based on similarities to other drugs in the same category is nothing new. Class labeling can be expected for Continue reading Profiling Solithromycin: FDA AMDAC on Solithera

Discontinued But Not Forgotten: HCV Drugs That Did Not Make It

I find it useful to look back and review drug candidates that were stopped in development.  In case of insufficient efficacy, i.e., not enough of a VL reduction or early viral rebound, everyone can sympathize with the decision to discontinue Continue reading Discontinued But Not Forgotten: HCV Drugs That Did Not Make It