Progress Report: New Antibacterials In the Fight against MDR Bacteria

Since the beginning of this millennium we have seen antibiotic R&D dwindle year after year. There are many reasons for this; while economics are often cited for this decline, the FDA and the ‘Guideline Wars’, i.e., those never ending discussions Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria

Solithromycin CAP Study:  Cap the Details (in the Publication)

In a recent publication, the results of a large Phase 3 trial comparing solithromycin with moxifloxacin in the treatment of CAP are presented [1]. As this was a global registration trial, we should refer to the indication as CABP, the current Continue reading Solithromycin CAP Study:  Cap the Details (in the Publication)

IV Fosfomycin To The Rescue – And To a Place Near You

A recent letter to the Editor by Simkins et al. is worth reviewing [1]. The authors describe the complicated course of a patient who suffered graft rejection after liver transplantation, received broad-spectrum antibiotics during prolonged hospitalization and eventually had a Continue reading IV Fosfomycin To The Rescue – And To a Place Near You

Artie’s Law: Avoid Bad Advice and Don’t Follow ‘Mission Impossible’ Advice

In this day and age, few truly broad spectrum antibiotics are in development, although this does not hold true for narrow-spectrums.  Just think of all the MRSA drugs (quinolones, FabI inhibitors), the pseudomonas drugs (NCEs and monoclonals) or some narrow Continue reading Artie’s Law: Avoid Bad Advice and Don’t Follow ‘Mission Impossible’ Advice

The New cUTI Guideline: A Look at the ‘Evolving Thinking’ at FDA

Just to refresh everyone’s memory: First, we had the Points-To-Consider document of 1993, then the 1998 Guidance, followed by the 2012 Guidance and now the 2015 Guidance for the conduct of registration studies in cUTI.  They all have served us Continue reading The New cUTI Guideline: A Look at the ‘Evolving Thinking’ at FDA

Commenting on Comments:  The Ceftaroline Trial Program in CABP

The ceftaroline (Teflaro®) program was executed at a time when FDA was debating a new CABP Guidance with new outcome measures: no longer was the time-honored TOC assessment acceptable, instead improvement on Day 3-5 was to become the new primary Continue reading Commenting on Comments:  The Ceftaroline Trial Program in CABP

Meropenem Dosing for VAP: High + Prolonged Beats Conventional Dosing

Sometimes an article pops up addressing a question we have been mulling over for quite some time.  It so happened with a recent publication which shed new light on penem dosing for ICU patients[1]. Conducted at a single Belgian centre Continue reading Meropenem Dosing for VAP: High + Prolonged Beats Conventional Dosing

The Circuitous Route to Phase 3:  Another Chapter in the Fitful Development of PTK-0796

When antibiotics change hands, it can be a good thing.  Small companies are often desperate to attract a partner with ‘deep pockets’ to help them finance an expensive late phase development but often have to give up control once the honeymoon Continue reading The Circuitous Route to Phase 3:  Another Chapter in the Fitful Development of PTK-0796

The Rapid Rise of Sulfonamide Diversity

Shortly after Domagk and Hörlein announced their discovery of the antibacterial properties of the dye sulfamidochrysoidine (Prontosil) in 1935, numerous chemical companies set out to modify the chemical structure.  They soon recognized the sulfa component as the true antibacterial and produced an incredible Continue reading The Rapid Rise of Sulfonamide Diversity

Trial Pains Secondary to Placebo Effect?

An interesting report has just been published showing that Naloxegol is beneficial in OIC [i].  Naloxegol is a µ opioid receptor (MOR) antagonist which – by virtue of pegylation – acts peripherally and not centrally.  Hence, the analgesic effects of Continue reading Trial Pains Secondary to Placebo Effect?