Tag Archives: MDR pathogens

Progress Report: New Antibacterials In the Fight against MDR Bacteria

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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 about regulatory requirements, have contributed to this trend in a Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria→

Does The Taxpayer Get Rewarded For Funding Such Studies?

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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 suited for PrEP of HIV for high-risk patients who nowadays are Continue reading Does The Taxpayer Get Rewarded For Funding Such Studies?→

No Such Thing as a Free Ride…

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..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…→