Allphase Pharma Consulting, LLC
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A new Guideline for the treatment of cUTI just arrived.[1] First, we are glad that this somewhat mundane topic receives the attention it deserves. UTIs are often downplayed as minor infections, but the cUTI variety should not be taken lightly. Many patients still are admitted with life-threatening infections, so prompt Continue reading NEW IDSA cUTI GUIDELINE
This December, Achaogen released much data on 2 plazomicin trials[1]: the pivotal EPIC study comparing plazomicin / levofloxacin with meropenem / levofloxacin in cUTI is the one we want to look at today because it is interpretable, while the other trial called CARE is not. CARE is one of those observational Continue reading All Smiles at the Press Conference: Plazo+Levo Delivers
Just to refresh everyone’s memory: First, we had the Points-To-Consider document of 1993, then the 1998 Guidance, followed by the 2012 Guidance and now the 2015 Guidance for the conduct of registration studies in cUTI. They all have served us well and I cannot recall a situation when a drug Continue reading The New cUTI Guideline: A Look at the ‘Evolving Thinking’ at FDA