Allphase Pharma Consulting, LLC
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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
A Phase 1 study evaluating tigecycline (Tygacil®) to treat refractory Acute Myeloid Leukemia is currently underway? [1] Niacin extended release tablets (nicotinic acid, Niaspan®) was associated with a significantly higher rate of infections (appendicitis, bronchitis, cellulitis) compared to placebo in the AIM-HIGH trial which enrolled over 3400 patients? [2] Macrolides Continue reading Did you know that…
Solomkin et al. conclude that the efficacy and safety of eravacycline compares favorably to the control drug, ertapenem.[1] This top-level assessment is made with the usual caveats (insufficient statistical power, small sample size), but a few points deserve comment. Eravacycline is a fluorocycline; as a tetracycline derivative it follows into Continue reading Some Thoughts about Eravacycline Based on the Phase 2 cIAI Study