Treating Serious CRAB Infections

There are MDR pathogens, and there is carbapenem-resistant A. baumannii, aka CRAB. This surely must be one of the most formidable bacterial organisms. It has resistance mechanisms second to none.  When found in patients, it is very difficult to eradicate and extremely difficult to get rid off, once established in Continue reading Treating Serious CRAB Infections

IgAN Therapeutics – The Race is On

Is there a new trend in the journal world:  publication of interim analysis (IA) results? The NEJM recently published two articles back to back, both highlighting 9 month ‘interim’ data from Phase 3 pivotal trials in IgAN. The primary efficacy endpoint used in either study was UPCR at 9 months, Continue reading IgAN Therapeutics – The Race is On

Idefirix PDUFA Date and the IdeS of March

The pivotal ConfIdeS study has finished enrollment and is now with the FDA.  IdeS is imlifidase, with the brand name Idefirix.  It has been conditionally approved by EMA and is on the market in Europe since 2020.  Idefirix is a niche product, an orphan drug.  It is a cysteine protease Continue reading Idefirix PDUFA Date and the IdeS of March