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Is there a new trend in the journal world: publication of interim analysis (IA) results? The NEJM recently published two articles back to back, both highlighting 9 month ‘interim’ data from Phase 3 pivotal trials in IgAN. The primary efficacy endpoint used in either study was UPCR at 9 months, Continue reading IgAN Therapeutics – The Race is On
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
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