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?
In a recent publication, the results of a large Phase 3 trial comparing solithromycin with moxifloxacin in the treatment of CAP are presented [1]. As this was a global registration trial, we should refer to the indication as CABP, the current FDA acronym for a very defined entity which has some Continue reading Solithromycin CAP Study: Cap the Details (in the Publication)
Once upon a time – not so long ago – we were taught the following: Streptococcus pneumoniae was the cause of 90% of CAP cases. That statement was later modified to mean S. pneumoniae was the underlying pathogen in 90% of bacterial cases of CAP, i.e., those with positive cultures from sputum or Continue reading The Etiology of CAP Remains Elusive – A Call to Change Antibiotic Prescribing Patterns