Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
SH: My dear Watson, did you read the news of the astonishing debacle that befell Mme Erava and made the headlines, creating anxiety of hitherto unknown proportions in Tetraland? Dr.W.: A disaster of epic proportions, for sure, and a mystery, an explanation which will require some very expert investigation. There is Continue reading Mme Erava and The Mysterious Case of Auto-Combustion
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
On Feb 25, 2015 the combination of ceftazidime/avibactam (Avycaz) was approved by FDA for cUTI and cIAI infections in patients ‘who have limited or no alternative treatment options’. As a QIDP drug, Avycaz received priority review. Its label states that it is indicated for infections caused by pathogens proven or ‘suspected to Continue reading Avycaz Approval and Labeling Restrictions