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
Cabotegravir (S-1265744) is an integrase inhibitor similar to dolutegravir. When formulated as a long-acting drug using crystalline nanoparticle technology it is called GSK’744 LAP. When injected intramuscularly, ‘744 LAP it has a half-life of >1 month which makes it ideally Continue reading Does The Taxpayer Get Rewarded For Funding Such Studies?
..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 Continue reading No Such Thing as a Free Ride…
Fosfomycin Who would have thought that a drug that has been around since 1969  could become eligible for QIDP status in 2015? Well, Zavante Therapeutics recently garnered the coveted QIDP designation for fosfomycin IV. This formulation has been available Continue reading A Renaissance for Old Drugs: Fosfomycin and Colistin
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