Plazomicin – A Quick Take On A Complex Drug With A Complex Development Path

Whenever a new drug is in late stage development, its prospects become the focus of intense scrutiny. Plazomicin (ACHN-490), like any Phase 3 drug should be evaluated along the following dimensions: Differentiation: within its class & compared to competitors: Does it have a unique clearly definable profile? Addressing an unmet need: Continue reading Plazomicin – A Quick Take On A Complex Drug With A Complex Development Path

Why Moxifloxacin’s Approval for Plague Is So Disturbing

PLEASE SHARE YOUR OPINION AND VOTE BELOW On May 8th, 2015 moxifloxacin/Avelox was approved for treatment of inhalational plague.[1]   We learn that the approval followed the ‘animal rule’ process, and that treatment with moxifloxacin was 100% effective in the African Green Monkey (AGM) model of lung infection.  By contrast, 0% of Continue reading Why Moxifloxacin’s Approval for Plague Is So Disturbing

Tenofovir, BMD and Monitoring of Renal Function

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 BMD in patients who are already at an increased risk Continue reading Tenofovir, BMD and Monitoring of Renal Function