Allphase Pharma Consulting, LLC
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“The medicine comes for free, just pay us for the inhaler” should be the marketing slogan for this group of therapeutics. Nebulizers are good business: hard to copy as a delivery system, they are a great opportunity to ‘evergreen’ off-patent antibiotics. The inhalational route to administer antibiotics is clearly attractive. Continue reading Aerosolized Antibiotics & Selling Nebulizers
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
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