Allphase Pharma Consulting, LLC
A Professional Service Provider for the Pharma Industry
There are studies that are bound to succeed, and those that are likely to fail. A failed trial is nothing to be proud of – and in this case, it was a gamble against overwhelming odds. We feel the Gilead marketing department was pushing their luck big time with this Continue reading Obeldesivir Fails in Yet Another Study
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 was driven by ID clinicians and by antibiotic developers concerned Continue reading The 10 x ’20 Initiative – A Retrospective
At the recent FDA workshop on narrow-spectrum antibiotic development[1], the concept of using bacteriological response (BR) as an efficacy endpoint was flat-out rejected. The reason given is the purported lack of correlation between BR and survival/mortality which FDA considers the most important clinical endpoint[2]. FDA felt so strongly about this, Continue reading The Weak Correlation Between Antibiotic Action and Mortality