Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
It started all so well with fanfare and great expectations. Fifteen years ago, the 10 x ’20 initiative got underway. Its goals were spelled out clearly: To ‘Pursue a Global Commitment to Develop 10 New Antibacterial Drugs by 2020 ’[3]. It Continue reading The 10 x ’20 Initiative – A Retrospective
GSK’s pipeline in anti-infectives is impressive. It comprises drugs for bacterial, mycobacterial, fungal, viral infections, and for malaria; in addition, they have a number of vaccines in development. Several antibiotics are listed on their website targeting UTI pathogens, and one Continue reading BLUJEPA / Gepotidacin APPROVED FOR UNCOMPLICATED UTI – 1
Study Design in ABSSSI – A Statistician’s Delight The design of the O’Riordan ABSSI study [1] deserves comment. This was a double-blind study of 2 lower dose arms (Part 1) with an add-on open-label (Part 2) high-dose arm. The pimary Continue reading Gepotidacin ABSSSI – How to Fail Adaptively,
We will get to the new Hoberman study[1] in a moment, but first a bit of background. AOM, AECS and AECB were labeled indications for antibiotics in the 80s and 90s but were summarily thrown out from the indication catalogue Continue reading Is the AOM Indication Making a Come-Back?
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 Continue reading Progress Report: New Antibacterials In the Fight against MDR Bacteria