ANTIBIOTIC DEVELOPMENT IN PHARMA IS DEAD – FOR NOW

This is a somewhat nostalgic retro blog.  I was leafing through a book by Vince Andriole called ‘The Quinolones’.[1]  First released in 1988, its third edition is from 2000.  It provided in-depth coverage of quinolone chemistry, PK, microbiology, efficacy and safety.  It was a great review of the large and Continue reading ANTIBIOTIC DEVELOPMENT IN PHARMA IS DEAD – FOR NOW

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 are listed in the Main Table below. With the recent Continue reading QIDP Antibiotics – 2015 Year-End Update

The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?

Any FDA meeting is a high-stakes game for industry:  One never knows how the discussions will go. Some oddball issue may take center stage and usurp much time, creating an unbalanced perspective.  At other times, simple issues seem to create controversy, questions are not properly understood in the context of Continue reading The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?