QIDP Drugs – 4th Edition

>>> For the latest QIDP list, please click HERE  <<< Since our last QIDP blog from April 8, 2015, several new drugs have made the list which now includes 41 compounds. Below a table which includes compound, sponsor and development stage (Phase). It also indicates whether a drug has been the topic of a Continue reading QIDP Drugs – 4th Edition

No Such Thing as a Free Ride…

..when it comes to FDA review of antibiotic NDAs.  Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions.  Many failed not because of lack of efficacy or a bad safety profile but because of changes in Continue reading No Such Thing as a Free Ride…

The Antibiotic Pipeline: How “New” is New

In a recent ‘Viewpoint’ article, Dr. Fauci, Director of NIAID, mentioned that “industry has expanded the pipeline of new antibacterial drugs…with 14-agents currently in phase 3 clinical trials”.[1] Regarding the number of drugs in late development, his statement may be correct but many of these drugs are anything but new.  Reviewing Continue reading The Antibiotic Pipeline: How “New” is New