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
“The world is changed by your example, not by your opinion” (Paulo Coelho) Dear All, The AMR Action Fund (https://www.amractionfund.com/) announcement today was awesome … indeed, it brought tears to my eyes. I listened in parallel to the presentations from Berlin and Washington where we had an all-star cast of US Senators, EU Members of
Dear All, I wrote on 3 Jan 2020 (link) about the NIAID contract intended to establish an innovative Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB). The formal solicitation has now gone live and can be found here. The deadline for applications is 16 Mar 2020. Get to it! In parallel, there is a superb Wall Street Journal podcast dated 13 Jan 2020 about