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
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
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 stratospheric prices that oncology drugs or TNF alpha inhibitors command. Continue reading The EpiPen Episode, an Epitaph on Epinephrine as we know it, an Epilogue and an Epiphany