Progress Report: New Antibacterials In the Fight against MDR Bacteria

Since the beginning of this millennium we have seen antibiotic R&D dwindle year after year. There are many reasons for this; while economics are often cited for this decline, the FDA and the ‘Guideline Wars’, i.e., those never ending discussions about regulatory requirements, have contributed to this trend in a Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria

The 10 x ’20 Goal – Are We On Track?

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 oncology projects which had a much better ROI. The IDSA Continue reading The 10 x ’20 Goal – Are We On Track?

Most Anti-Infective Guidelines Don’t Get No Respect (Let Alone Use!)

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!)