Efficacy and Treatment Duration: Where is the Tipping Point?

Development pf antibacterials differs in several important ways from drug development in other areas, and the lack of standard dose-finding is just one of them. Dose-finding in its most basic form involves ascending amounts of drug for efficacy and safety; Continue reading Efficacy and Treatment Duration: Where is the Tipping Point?

TXA-709 –  New Kid on the Block

When searching for FtsZ inhibitors on PubMed, there are 187 hits. When narrowing down the search looking for clinical trials only, there are none. Taxis Pharmaceuticals obtained QIDP status for its candidate drug TXA-709 in late 2016 and it is Continue reading TXA-709 –  New Kid on the Block

Sulfonamides Revisited, With an Emphasis on Dapsone

The sulfonamide moiety is a remarkable structure giving rise to diverse drugs in arious therapeutic areas such as antibiotics, antidiabetics, diuretics and anti-inflammatory agents. In regards to antibiotics, sulfonamides are in common use as antifungals (P. jiroveci), antiparasitics (toxoplasmosis, cyclospora, isospora, Continue reading Sulfonamides Revisited, With an Emphasis on Dapsone

The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?

Any FDA meeting is a high-stakes game for industry:  One never knows how the discussions will go. Some oddball issue may take center stage and usurp much time, creating an unbalanced perspective.  At other times, simple issues seem to create Continue reading The FDA AMDAC on Fluoroquinolones (Part 2): Where Were the FQ Advocates?

Nitrofurantoin – An Old Drug Resurrected Needs Prospective Scrutiny

When older drugs get reintroduced into clinical practice because pathogens have developed resistance to newer agents, it comes at the price of uncertainty. Often, older drugs were approved based on rather limited data, often considered incomplete by today’s standards.  Take colistin Continue reading Nitrofurantoin – An Old Drug Resurrected Needs Prospective Scrutiny