Development pf antibacterials differs in several important ways from drug development in other areas, and the lack of standard dose-finding is just one of them. Dose-finding in its most basic form involves ascending amounts of drug for efficacy and safety; Continue reading Efficacy and Treatment Duration: Where is the Tipping Point?
A recent paper by Thabit describes a curious finding . 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
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
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
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