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
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
The treatment history of N. gonorrhoeae makes for fascinating reading. This organism has always been able to keep the upper hand in the war of bug versus drug. Once susceptible to sulfa drugs, to penicillin, tetracyclines and fluoroquinolones, it sequentially become resistant in the matter of a decade to every Continue reading A GO / NO GO decision: Delafloxacin Stumbles in Gonorrhea Study