Dear All, As you may remember, last fall I wrote a newsletter about ATMF’s 3rd update to the AMR Benchmark series. You are encouraged to read the report but in brief, the key messages are (i) the pipeline is small with most innovation coming from small biotech, (ii) stewardship and access planning are increasingly seen (but
Dear All, NIAID and RTI International have recently announced the initiation of CC4CARB Chemistry Center for Combating Antibiotic Resistance). In brief, CC4CARB synthesizes compound libraries (free of charge!) based on scaffolds that you propose The focus is on creating novel chemical matter that might have antibacterial activity (there appears to be a focus on Gram-negatives, but there
Dear All, IDSA (Infectious Diseases Society of America) have today released an eagerly awaited new guidance document on treating infections due to resistant Gram-negative bacteria (link). 8 Apr 2021 update: IDSA have published an updated version of this document. It excellent to see IDSA working steadily to provide up-to-the-minute advice! 24 Nov 2021 update: IDSA
Dear All (and with thanks to Kevin for leading the charge on this newsletter), While listening to last week’s BEAM-sponsored AMR Conference (really a wonderful conference, thank you Team BEAM, go here to listen to the sessions), we tumbled onto a really, really disturbing trend: New antibiotics are not being registered or sold in Europe in
Dear All (lots and lots of wonkish detail here, be sure your blood caffeine level is adequate!), During the 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference (go here or see below my signature for more), I had the opportunity on 27 August to chat with Sumati Nambiar (FDA) and Marco Cavaleri (EMA) about ongoing regulatory activities. The
Dear All, I hope everyone is finding a bit of time to go off-line during August … always a good month for that! To supplement your summer reading, we today have Alan Carr’s August 2020 update on antibacterials and antifungals (link). For those of you who don’t know Alan, he’s an Industry analyst at Needham
Dear All, FDA have released the final version of their LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs, really should be LPPAAAD) guidance. You can get it here. I have generated a comparison with the Jul 2018 draft version that you can get here. As a reminder, the central concept of the LPPAAAD pathway
Dear All, Once again, we’re going to have a brief change from our usual programming with this newsletter. I hope you recognize the name Alan Carr … he is an analyst at Needham & Company (https://www.needhamco.com/) who writes regularly on the antibacterial pipeline. Go here for the most recent (14 Aug 20) newsletter on his summaries:
Dear All, Alan Carr has just released his Jan 2020 review of the antibacterial and antifungal market (link). For those of you not familiar with his work, Alan is an analyst for Needham & Company, LLC and has closely followed this space for several years. His newsletters are always deeply instructive and this one is
Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), While we’re all thrilled with the announcement of the AMR Action Fund (newsletter), we’ve also had in parallel a demonstration of why the fund alone is insufficient to solve the antibiotic innovation crisis (newsletter on withdrawal of plazomicin’s marketing application in Europe). Thus, it’s