The Monoclonal Pursuit of the Next CMV Therapeutic

There is no doubt that immunity to human cytomegalovirus (CMV) is both cell-and antibody-mediated. Studies in transplant patients showed that absence of T-cell protection with chemotherapy is a set-up for recurrent and severe CMV disease. It was also shown that patients with pre-existing CMV antibodies are less likely to develop CMV Continue reading The Monoclonal Pursuit of the Next CMV Therapeutic

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