This December, Achaogen released much data on 2 plazomicin trials: the pivotal EPIC study comparing plazomicin / levofloxacin with meropenem / levofloxacin in cUTI is the one we want to look at today because it is interpretable, while the other trial Continue reading All Smiles at the Press Conference: Plazo+Levo Delivers
For a good long time, economists have been thinking about the reimbursement quandary for antibiotics, esp. antibacterials. They are just too cheap, right? Well, with the exception of HCV and some newer HIV drugs, few compounds have ever reached the Continue reading The EpiPen Episode, an Epitaph on Epinephrine as we know it, an Epilogue and an Epiphany
In the last decade (2000-2010), we saw the number of new antibiotic approvals drop successively each year; FDA changed the rules of the approval process without providing public guidance; many antibiotic companies fled the therapeutic area; investments were redirected to Continue reading The 10 x ’20 Goal – Are We On Track?
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 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 Continue reading Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)