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

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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→

Nitrofurantoin – An Old Drug Resurrected Needs Prospective Scrutiny

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When older drugs get reintroduced into clinical practice because pathogens have developed resistance to newer agents, it comes at the price of uncertainty. Often, older drugs were approved based on rather limited data, often considered incomplete by today’s standards.  Take colistin as an example: approved in the early 60ies, we still Continue reading Nitrofurantoin – An Old Drug Resurrected Needs Prospective Scrutiny→

Why Moxifloxacin’s Approval for Plague Is So Disturbing

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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→