Omissions – Commissions – Errors – Blunders – Solithromycin

Cempra received a complete response letter (CRL) as a X-mas present from FDA, and the news was pretty bad for company investors. Bad, but not totally unexpected after the AMDAC meeting last November, which taught us a few new things Continue reading Omissions – Commissions – Errors – Blunders – Solithromycin

Solithromycin SOLITAIRE-IV: So-So Results for a So-So Drug

Just before the November 4th AMDAC on solithromycin, we are being treated to a very fine piece of study write-up. Of course, we are speaking of the File paper on the SOLITAIRE-IV trial, and what a fine piece of crafty Continue reading Solithromycin SOLITAIRE-IV: So-So Results for a So-So Drug

QIDP Antibiotics – 2015 Year-End Update

Here an updated listing of all QIDP drugs we are aware of as of 12/24/2015. Today just facts and numbers; we will provide an interpretation of the current landscape in upcoming blogs. There are 58 drugs which garnered QIDP status and these Continue reading QIDP Antibiotics – 2015 Year-End Update

Why Moxifloxacin’s Approval for Plague Is So Disturbing

PLEASE SHARE YOUR OPINION AND VOTE BELOW On May 8th, 2015 moxifloxacin/Avelox was approved for treatment of inhalational plague.[1]   We learn that the approval followed the ‘animal rule’ process, and that treatment with moxifloxacin was 100% effective in the African Green Continue reading Why Moxifloxacin’s Approval for Plague Is So Disturbing

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