Month: September 2016

A Patch? YES – A Fix? NO: This Emperor Has No Clothes

Posted on by — No Comments ↓

The NIH Department of HHS released its Final Rule on “Clinical Trials Registration and Results Information Submission” [1]. This Rule is meant to address frustrating maintenance and compliance issues in the ClinicalTrials.gov database, especially the results reporting section which has been neglected or totally ignored, (we commented on this in Continue reading A Patch? YES – A Fix? NO: This Emperor Has No Clothes→

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

Posted on by — 2 Comments ↓

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 effect was rather dramatic: an increase in protein binding from 12% Continue reading Timely New Information on Next-Generation Tetracyclines – Part 2: Eravacycline and Protein Binding→

Timely New Information on Next-Generation Tetracyclines – Part 1: Omadacycline and Cardiac AEs

Posted on by — No Comments ↓

Several interesting articles appeared recently which shed light on the efficacy of eravacycline and the safety of omadacycline, both in Phase 3 and both in a head-to-head race to the market.  Well, the term ‘race’ is bit of a stretch as both drugs have seen very significant delays in development. Omadacycline from Continue reading Timely New Information on Next-Generation Tetracyclines – Part 1: Omadacycline and Cardiac AEs→