Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
It is time for a new look at the field of QIDP drugs. Today we are providing an updated searchable database which now has 57 entries. (Status: 10/18/16) Despite best efforts to provide accurate information, errors may have crept in. Please let us know if you detect mistakes. We will make corrections or post Continue reading QIDP Drug Update – Part 1: An Updated Who Is Who
Dalbavancin has changed hands a few times in its development history, moving from Lilly to Vicuron, then Pfizer and ultimately Durata. The original NDA for dalbavancin was submitted to FDA on Dec. 21, 2004. Pfizer acquired dalbavancin as a “Phase 3 completed” drug ready for world-wide marketing on June 15, 2005. The Continue reading Dalbavancin Approval Issues: A Case of Much Ado About Nothing
Whenever a new drug is in late stage development, its prospects become the focus of intense scrutiny. Plazomicin (ACHN-490), like any Phase 3 drug should be evaluated along the following dimensions: Differentiation: within its class & compared to competitors: Does it have a unique clearly definable profile? Addressing an unmet need: Continue reading Plazomicin – A Quick Take On A Complex Drug With A Complex Development Path