Efficacy and Treatment Duration: Where is the Tipping Point?

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; for antibiotics, however, an effective dose can be predicted nowadays Continue reading Efficacy and Treatment Duration: Where is the Tipping Point?

Prospecting for New Antibiotics

The QIDP designation was introduced in 2012 to incentivize drug development in antiinfectives. QIDP came with several attractive features, such as prolongation of patent life, FDA expedited review and more.  In addition, FDA made it quite easy to garner the label.  As you can see, there is really no downside to Continue reading Prospecting for New Antibiotics

Solithromycin SOLITAIRE-IV: So-So Results for a So-So Drug

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 penmanship it is, if you haven’t noticed. Just as a Continue reading Solithromycin SOLITAIRE-IV: So-So Results for a So-So Drug