The Weak Correlation Between Antibiotic Action and Mortality

At the recent FDA workshop on narrow-spectrum antibiotic development[1], the concept of using bacteriological response (BR) as an efficacy endpoint was flat-out rejected. The reason given is the purported lack of correlation between BR and survival/mortality which FDA considers the Continue reading The Weak Correlation Between Antibiotic Action and Mortality

The EpiPen Episode, an Epitaph on Epinephrine as we know it, an Epilogue and an Epiphany

For a good long time, economists have been thinking about the reimbursement quandary for antibiotics, esp. antibacterials. They are just too cheap, right?  Well, with the exception of HCV and some newer HIV drugs, few compounds have ever reached the Continue reading The EpiPen Episode, an Epitaph on Epinephrine as we know it, an Epilogue and an Epiphany

Discontinued But Not Forgotten: HCV Drugs That Did Not Make It

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

2014: The Year That Changed The Landscape of HCV Therapy

It was déjà vu all over again, albeit compressed in time: when the race started to replace PegIFN+RBV for the treatment of HCV infection, the learnings from HIV drug development and the lessons with HAART provided an excellent template for quick Continue reading 2014: The Year That Changed The Landscape of HCV Therapy

Did you know that…

A Phase 1 study evaluating tigecycline (Tygacil®) to treat refractory Acute Myeloid Leukemia is currently underway? [1] Niacin extended release tablets (nicotinic acid, Niaspan®) was associated with a significantly higher rate of infections (appendicitis, bronchitis, cellulitis) compared to placebo in Continue reading Did you know that…