At the recent FDA workshop on narrow-spectrum antibiotic development, 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 Continue reading The Weak Correlation Between Antibiotic Action and Mortality
The nomination of Dr. Scott Gottlieb for FDA commissioner, a political appointee, has created the usual bipartisan furor. He is called unqualified, a renegade, not committed enough to FDA orthodoxy, an industry darling by some and a maverick by others. All Continue reading FDA Needs Radical Reform
Usually, as development progresses from preclinical to a more advanced clinical stage, reality begins to set in: problems become apparent that were not anticipated, efficacy may be less than expected or hoped for, and the safety margins may shrink to Continue reading The Letermovir Top-Line Results are Out – Or Are They?
Pfizer discontinued US distribution of spectinomycin (Trobicin®) in November 2005; remaining inventory expired in May 2006 . Nonetheless, at the FDA website we still find a Package Insert for Trobicin updated as late as Aug 2012, a thin 6-page leaflet which Continue reading The CDC and Spectinomycin
Besides ceftriaxone (CTRIAX), cefixime and spectinomycin we have no other highly effective single-dose treatment regimens for urogenital GC. Failures of all 3 drugs have been described but remain rare, can be overcome with higher doses of CTRIAX (1 g instead Continue reading GC Therapy – Shooting for the Stars