Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
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
“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