Only now, a few days before the actual AMDAC meeting, the FDA’s Briefing Document becomes available to the public. The topic of the December 5th meeting: Reappraisal of the risk/benefit of fluoroquinolones (FQ) in approved but “mild, self-limiting” disease indications in Continue reading AMDAC November 5, 2015 on Fluoroquinolones in ABS, ABECB, uUTI – Part 1
At around this time (July 2015), Cellceutix is expected to hammer out a Phase 3 program for brilacidin, its defensin-mimetic and host-defense protein (HDP) mimic structurally similar to magainin, with FDA. Brilacidin is certainly an interesting novel compound, coming from a Continue reading Brilacidin – QIDP Drug At a Critical Juncture
The approved tenofovir / Viread label lists not only standard nucleoside-class side effects but also – since an update in 2012 – makes mention of diminished bone mineral density (BMD) in the Warnings / Precautions section. Demonstrating that a particular drug affects Continue reading Tenofovir, BMD and Monitoring of Renal Function
I find it useful to look back and review drug candidates that were stopped in development. In case of insufficient efficacy, i.e., not enough of a VL reduction or early viral rebound, everyone can sympathize with the decision to discontinue Continue reading Discontinued But Not Forgotten: HCV Drugs That Did Not Make It
There are currently a total of 6 beta-lactam + beta-lactamase inhibitor combinations in clinical trials. It will be a steep learning curve for the pharma reps (and physicians) to understand the resistance classifications, the confusing ESBL definitions, the CRE nomenclature, Continue reading What is the “Niche” for Ceftolozane / Tazobactam?