All Smiles at the Press Conference: Plazo+Levo Delivers

This December, Achaogen released much data on 2 plazomicin trials[1]: the pivotal EPIC study comparing plazomicin / levofloxacin with meropenem / levofloxacin in cUTI is the one we want to look at today because it is interpretable, while the other trial Continue reading All Smiles at the Press Conference: Plazo+Levo Delivers

Timely New Information on Next-Generation Tetracyclines – Part 2: Eravacycline and Protein Binding

A recent paper by Thabit describes a curious finding [1]. The authors measured total and free (i.e., nonprotein-bound) eravacycline levels at ascending doses in a mouse model. They found strikingly small increases in free drug levels when titrating up total doses. The Continue reading Timely New Information on Next-Generation Tetracyclines – Part 2: Eravacycline and Protein Binding

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

Eravacycline Conference Call: Unrevealing and Disappointing

Whatever has become of investigative journalism?  All we read after the Stifel conference call (11/17/2015) is descriptive rehash of information provided by Tetraphase at the conference.  No probing questions that we thought investors would ask who just lost 80% of Continue reading Eravacycline Conference Call: Unrevealing and Disappointing

After ICAAC: Some More Thoughts on Eravacycline in cUTI and IGNITE-2

When a well-designed pivotal Phase 3 trial fails to show NI, it demands an explanation.  While awaiting the company’s analysis of the data, many possible explanations are bandied about.  So it was not surprising that the eravacycline cUTI study (IGNITE-2) Continue reading After ICAAC: Some More Thoughts on Eravacycline in cUTI and IGNITE-2

Mme Erava and The Mysterious Case of Auto-Combustion

SH: My dear Watson, did you read the news of the astonishing debacle that befell Mme Erava and made the headlines, creating anxiety of hitherto unknown proportions in Tetraland? Dr.W.: A disaster of epic proportions, for sure, and a mystery, Continue reading Mme Erava and The Mysterious Case of Auto-Combustion

Avycaz Approval and Labeling Restrictions

On Feb 25, 2015 the combination of ceftazidime/avibactam (Avycaz) was approved by FDA for cUTI and cIAI infections in patients ‘who have limited or no alternative treatment options’.  As a QIDP drug, Avycaz received priority review.  Its label states that it is Continue reading Avycaz Approval and Labeling Restrictions

Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)

It is no secret that most existing antibiotic guidelines are not getting much use these days.  The only indications pursued with any regularity are the feasible ones: ABSSSI, cUTI, and cIAI, much less CABP.  Yes, the occasional HABP/VABP trial is Continue reading Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)

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

Some Thoughts about Eravacycline Based on the Phase 2 cIAI Study

Solomkin et al. conclude that the efficacy and safety of eravacycline compares favorably to the control drug, ertapenem.[1]  This top-level assessment is made with the usual caveats (insufficient statistical power, small sample size), but a few points deserve comment. Eravacycline Continue reading Some Thoughts about Eravacycline Based on the Phase 2 cIAI Study

What is the “Niche” for Ceftolozane / Tazobactam?

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?