A Critical Review of WHO’s List of Antibacterials in Clinical Development

WHO compiles a list of antibacterials in clinical development on a regular basis, the last in mid-2024 [1].  The information is up-to-date and detailed: it provides MoA and antibacterial spectrum, coverage of problem pathogens, the development phase, and whether it Continue reading A Critical Review of WHO’s List of Antibacterials in Clinical Development

Some Thoughts about the New Coronavirus Syndrome and its Transmission

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

FDA Needs Radical Reform

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

The Letermovir Top-Line Results are Out – Or Are They?

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?

The CDC and Spectinomycin

Pfizer discontinued US distribution of spectinomycin (Trobicin®) in November 2005; remaining inventory expired in May 2006 [1]. 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