First and upfront, let’s call this virus WARS*, which stands for Wuhan Associated Respiratory Syndrome. President Xi Jingping called for a war against the new virus, and a war it is. Therefore our acronym makes intuitive sense. The naming of Continue reading Some Thoughts about the New Coronavirus Syndrome and its Transmission
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