Dear All, Long note alert: Set aside at least 30 minutes for this one … there’s a lot of important material here. Last week’s workshop entitled “Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States” was an unusual and unusually instructive meeting. You can go here for the meeting materials but as there are
Dear All, Please mark your calendar now to be in the Washington, DC area on 18-19 Nov 2019 for a 2-day workshop at FDA’s White Oak Campus focused on enhancing the clinical trial enterprise for antibacterial drug development. Jointly co-sponsored by FDA, IDSA, NIAID, and Pew Trusts, this meeting will have a particular focus on (a)
Dear All, Last fall, the team at ATMF (Access to Medicine Foundation) released the 3rd update to the AMR Benchmark series and Damiano de Felice was a guest author for a newsletter about the findings. That report offered a wealth of granular data, in-depth analyses and revealing graphs about what pharmaceutical companies in the global antibiotic and
Dear All, Our colleagues in Europe have been busy! Along with yesterday’s announcement about transferrable exclusivity vouchers, we also had publication of the Horizon Europe Work Programme 2026-2027. It’s a really big program that includes within its Cluster 1 a trio of calls of interest to readers of this newsletter: HORIZON-HLTH-2027-01-DISEASE-08 call seeks projects developing
Dear All (wonkish … but worth it … get ready to follow the links!), Greetings in the new year! As a marvelous way to end the last year, the US FDA announced on 12 Dec 2025 its approval of two new oral therapies for gonorrhea, thus addressing the priority pathogen lists of both WHO (High
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 access itself
This is the fourth of a 5-part newsletter series. There is an initial 27 Sep 2023 newsletter introducing the EPA concept note, a second (28 Sep 2023) newsletter that expands on the EPA concept note, a third (12 Jan 2024) newsletter about ending the use of streptomycin spray on citrus crops, and a fifth newsletter (11 Oct 2024) about the EPA’s collaborative framework for evaluating the AMR
Dear All, Non-traditional alternatives to antibiotics have excited a lot of interest in the past few years but we’ve seen relatively few of these progress in a meaningful way (go here for Pew’s recent survey of the development landscape). Providing insights into the challenges of this area, two valuable and complementary articles on non-traditional antibiotics have recently
Dear All, Novel antibacterial agents, vaccines, and diagnostics will do little if they are not widely available and used responsibly. CDDEP’s recent report entitled “The State of the World’s Antibiotics in 2021” makes this very clear: “… more people in LMICs (low-middle-income countries) die from lack of access to antimicrobials than from resistant infection.” Hence, CARB-X has
Dear All: Two new events on the near-term horizon. First, FDA has announced an Antimicrobial Drugs Advisory Committee for 11 Jan 2018 (and materials from the meeting can now be found here). Per the FR notice, this AMDAC will cover Aradigm’s inhaled ciprofloxacin for non-CF bronchiectasis and is almost certainly a discussion of the results Aradigm’s ORBIT-3