Dear All, BARDA have published an RFP (Request for Proposals) under which it would support clinical development and then stockpiling of an antibiotic for “treatment of bacterial pneumonia or bloodstream infections.” Here are the data you need to get started: RFP #: 75A50125R00005 https://sam.gov/opp/494fc05d7c4940abad0273cdb465079a/view Submission deadline is 26 Aug 2025 Quoting liberally from the online
Dear All (and with thanks to Vega Masignani for co-authoring this newsletter), Waaaay back in 2019 (pre-COVID … remember that?), Wellcome put out a call for grants focused on understanding the value of vaccines in combatting AMR (4 June 2019 newsletter entitled “Why vaccines for AMR? What is their value? Grant opportunity for research on
Dear All, I wrote in a 12 Dec 2024 newsletter (“Mirror Bacteria: An AMR threat of unprecedented magnitude”) about the really disturbing possible threat from creation of “mirror” bacteria in which all chiral elements of the bacterium are replaced by their enantiomeric counterparts. Such bacteria are predicted to be able to evade many (if not most)
Dear All, An updated version of FDA’s very helpful Q&A entitled “Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers” has just been released. Here are the links you need to get started: The new June 2025 guidance itself The webpage about the guidance
Dear All, Referring back to the actions planned following the 2024 UNGA HLM on AMR (UN General Assembly High-Level Meeting on AMR; 1 Oct 2024 newsletter and our dedicated UNGA 2024 webpage), you will hopefully recall the commitment to create an Independent Panel on Evidence for Action against AMR (IPEA). The broad idea is the
Dear All (Deeply wonkish alert! Settle in! Great stuff here!): For today, we have a deep dive into the ongoing work in the EU to develop a set of realistic pull incentives using our best understanding to date of realistic choices. If the idea of Pull (and Push) is new to you, please check out
Dear All (and with thanks to Betsy Trainor for co-authoring), The idea of the STEDI values of an antibiotic (its fire extinguisher-like values) comes up often. As a reminder, the STEDI values are Spectrum, Transmission, Enablement, Diversity, and Insurance. As a good example, consider Enablement: knowing that an antibiotic exists as a backup makes safe
Dear All, Attention phage developers — the UK MHRA have compiled all their regulatory guidance for phage into one convenient location! The overview webpage gives these comments: https://www.gov.uk/government/publications/regulatory-considerations-for-therapeutic-use-of-bacteriophages-in-the-uk “The MHRA has compiled a document containing all the relevant regulatory guidance pertinent to the development of phage therapeutic products. “Regulatory agencies and organisations have produced documentation
Dear All, D-Day and the momentous Normandy landings were 81 years ago today. In a marvelous new article on bbc.com (and with thanks to Mike Hodges for pointing it out), we can read about how “Handwritten notes reveal Churchill’s penicillin concern ahead of D-Day.” The magic of penicillin was evident … but there wasn’t enough of
Dear All, Pushing this one out as a direct quote from the online materials posted yesterday by FDA. Looks interesting! All best wishes, –jr The U.S. Food and Drug Administration is conducting a national listening tour to meet directly with pharmaceutical and biotech CEOs. Held in major innovation hubs across the country, the CEO Forums will