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Antibiotic Inhalers Galore (Part 1):  More Combinations and Permutations than a Rubik’s Cube

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There is much interest in inhaled antibiotics these days.  Prima facie, the logic for this approach is compelling: Getting the antibiotic (and a lot of it) directly to the site of infection, while avoiding systemic toxicity, sounds like optimized efficacy plus optimized safety combined.  However, some high-profile failures were published Continue reading Antibiotic Inhalers Galore (Part 1):  More Combinations and Permutations than a Rubik’s Cube→

Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 3)

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VABP is clearly the main indication to be pursued by a drug like POL7080.  Here is the question: How to conduct a study demonstrating efficacy for a drug which only has a single-organism spectrum?  Which is actually no spectrum at all.  Existing guidelines for the development of ID drugs are indication-driven, with Continue reading Polyphor POL7080 And The Journey to The Land of Pyocyanea (Part 3)→

Avycaz Approval and Labeling Restrictions

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On Feb 25, 2015 the combination of ceftazidime/avibactam (Avycaz) was approved by FDA for cUTI and cIAI infections in patients ‘who have limited or no alternative treatment options’.  As a QIDP drug, Avycaz received priority review.  Its label states that it is indicated for infections caused by pathogens proven or ‘suspected to Continue reading Avycaz Approval and Labeling Restrictions→