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
There are only 3 CDI drugs in wider clinical use: vancomycin, metronidazole, and fidaxomicin. They are from totally different classes and have almost nothing in common except for proven efficacy in C. difficile infection (CDI). Like vancomycin, the entire group Continue reading Quo Vadis, CDI Drugs?
In the last decade (2000-2010), we saw the number of new antibiotic approvals drop successively each year; FDA changed the rules of the approval process without providing public guidance; many antibiotic companies fled the therapeutic area; investments were redirected to Continue reading The 10 x ’20 Goal – Are We On Track?
..when it comes to FDA review of antibiotic NDAs. Some seem to have forgotten the dismal record of antibiotic approvals in the last 15 years, and the long list of failed submissions. Many failed not because of lack of efficacy Continue reading No Such Thing as a Free Ride…
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. Continue reading Why Some Did Not Make It