Sulopenem uUTI – Does It Suffice?

Sulopenem / ORLYNVAH approved for uUTI When Iterum, a Pfizer spin-off of sorts, took over sulopenem development in 2015, there was still hope for approvals of this drug in multiple indications such as uUTI, cUTI, cIAI and even CABP.  Ten years later and after an FDA rejection CRL in 2021, Continue reading Sulopenem uUTI – Does It Suffice?

QIDP, a Liberal Hand-Out from FDA

On our blog site, ‘QIDP’ stands for “Qualified Infectious Diseases Product” but when you look up ‘QIDP’ on the internet, you will find that it also stands for “Qualified Intellectual Disabilities Professional”. Looking at the more recent crop of ID products that garnered QIDP status, you wonder whether there is Continue reading QIDP, a Liberal Hand-Out from FDA

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 still in preclinical testing. The drug’s target, bacterial replication machinery Continue reading TXA-709 –  New Kid on the Block