Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
The FDA web site usually provides label and review documents for approved drugs.[1] Emblaveo, the combination of aztreonam and avibactam, was approved in February 2025, almost ½ year ago, but clinical review documents are still not posted at the site.[2] Hence, we do not know how Regulators felt about the Continue reading An Intro to Emblaveo (aztreonam + avibactam)
A new Guideline for the treatment of cUTI just arrived.[1] First, we are glad that this somewhat mundane topic receives the attention it deserves. UTIs are often downplayed as minor infections, but the cUTI variety should not be taken lightly. Many patients still are admitted with life-threatening infections, so prompt Continue reading NEW IDSA cUTI GUIDELINE
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?