Development pf antibacterials differs in several important ways from drug development in other areas, and the lack of standard dose-finding is just one of them. Dose-finding in its most basic form involves ascending amounts of drug for efficacy and safety; Continue reading Efficacy and Treatment Duration: Where is the Tipping Point?
Just before the November 4th AMDAC on solithromycin, we are being treated to a very fine piece of study write-up. Of course, we are speaking of the File paper on the SOLITAIRE-IV trial, and what a fine piece of crafty Continue reading Solithromycin SOLITAIRE-IV: So-So Results for a So-So Drug
Several interesting articles appeared recently which shed light on the efficacy of eravacycline and the safety of omadacycline, both in Phase 3 and both in a head-to-head race to the market. Well, the term ‘race’ is bit of a stretch as both Continue reading Timely New Information on Next-Generation Tetracyclines – Part 1: Omadacycline and Cardiac AEs
When you search for ‘ceftidoren’ on Wikipedia, you will get a surprise: there is no entry. However, a search on the web tells us that Spectracef (ceftidoren pivoxil) still exists. Gee, now the drug is spelled ‘cefditoren’ and – looking Continue reading Choose your Outcome: How Design Minutiae Affect Trial Results
In a recent publication, the results of a large Phase 3 trial comparing solithromycin with moxifloxacin in the treatment of CAP are presented . As this was a global registration trial, we should refer to the indication as CABP, the current Continue reading Solithromycin CAP Study: Cap the Details (in the Publication)