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Vancomycin vs TMP/SMX for MRSA – Not the Final Word

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Vancomycin got a bad reputation since the early 90ies when it became clear that it was slow to provide clinical improvement and microbiologic cure in MRSA patients.  It was associated with prolonged bacteremia even when combined with rifampin [1].  And for MSSA, anti-staph penicillins like nafcillin were always the better choice. Then, Continue reading Vancomycin vs TMP/SMX for MRSA – Not the Final Word→

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…→

Commenting on Comments:  The Ceftaroline Trial Program in CABP

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The ceftaroline (Teflaro®) program was executed at a time when FDA was debating a new CABP Guidance with new outcome measures: no longer was the time-honored TOC assessment acceptable, instead improvement on Day 3-5 was to become the new primary endpoint.  FDA made other significant changes to the old 1998 Continue reading Commenting on Comments:  The Ceftaroline Trial Program in CABP→