Allphase Pharma Consulting, LLC
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..when it comes to FDA review of antibiotic NDAs. Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions. Many failed not because of lack of efficacy or a bad safety profile but because of changes in Continue reading No Such Thing as a Free Ride…
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
Looking at all antibiotics in the pipeline, I can’t help but think that – by 2018 – there will be some blockbuster anti-infectives coming to the market. Why do I say this? What is going to generate this revenue stream for companies when the new crop of drugs will be restricted by Continue reading Why The Next Novel Antibiotic Will Be A Blockbuster And Cost $40k