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
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
There are numerous reasons why drugs get stuck in development. Certainly, problems with efficacy or problems with safety are main reasons but there are many other ‘derailers’ as well. For instance regulatory issues or manufacturing, difficulties can stop a program. Occasionally, a suboptimal dose was chosen because of (1) incomplete Continue reading Why Some Did Not Make It