Allphase Pharma Consulting, LLC
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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…
Fosfomycin Who would have thought that a drug that has been around since 1969 [2] 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 in Europe for a quite some time but not in the Continue reading A Renaissance for Old Drugs: Fosfomycin and Colistin
When Al Gore became a best-selling author with “An Inconvenient Truth” he warned about climate change. When it comes to antibiotic resistance and the current situation of “Bad Bugs, No Drugs”, there are many voices warning us about a return to the pre-antibiotic era. Why does it take so long Continue reading An Inconvenient Truth: Ciprofloxacin-Resistant Campylobacter