Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
Sulopenem / ORLYNVAH approved for uUTI When Iterum, a Pfizer spin-off of sorts, took over sulopenem development in 2015, there was still hope for approvals of this drug in multiple indications such as uUTI, cUTI, cIAI and even CABP. Ten years later and after an FDA rejection CRL in 2021, Continue reading Sulopenem uUTI – Does It Suffice?
Pfizer discontinued US distribution of spectinomycin (Trobicin®) in November 2005; remaining inventory expired in May 2006 [1]. Nonetheless, at the FDA website we still find a Package Insert for Trobicin updated as late as Aug 2012, a thin 6-page leaflet which seems to have survived from the 80s. The drug is Continue reading The CDC and Spectinomycin
Often we come across a study which raises more questions than it answers. Sometimes we read a study publication again and again, and still we cannot figure out what the take-away learning is, as results are simply inconclusive or discordant. Occasionally we encounter studies with results that are so counterintuitive Continue reading Inconclusive Data in IA: Experts Fill the Void To Avoid Horror Vacui