Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
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
It is no secret that most existing antibiotic guidelines are not getting much use these days. The only indications pursued with any regularity are the feasible ones: ABSSSI, cUTI, and cIAI, much less CABP. Yes, the occasional HABP/VABP trial is being undertaken by the intrepid but no company has taken Continue reading Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)
The recently published INSIGHT trial showed that starting HIV therapy earlier rather than later has benefit for patients 1. This should not come as a surprise considering the excellent suppressive power of current triple regimens. The trial which enrolled 4685 HIV infected patients was stopped prematurely when an interim analysis Continue reading The Beauty of Science: No Need to Think About Costs When You Live in An Ivory Tower