Antibiotic Inhalers Galore (Part 1):  More Combinations and Permutations than a Rubik’s Cube

There is much interest in inhaled antibiotics these days.  Prima facie, the logic for this approach is compelling: Getting the antibiotic (and a lot of it) directly to the site of infection, while avoiding systemic toxicity, sounds like optimized efficacy plus optimized safety combined.  However, some high-profile failures were published Continue reading Antibiotic Inhalers Galore (Part 1):  More Combinations and Permutations than a Rubik’s Cube

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

Inconclusive Data in IA: Experts Fill the Void To Avoid Horror Vacui

Often we come across a study which raises more questions than it answers.  Sometimes we read a study publication again and again, and still we cannot figure out what the take-away learning is, as results are simply inconclusive or discordant. Occasionally we encounter studies with results that are so counterintuitive Continue reading Inconclusive Data in IA: Experts Fill the Void To Avoid Horror Vacui