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
Dear All, As in previous years (27 Mar 2024 newsletter), IDWeek 2025 will feature pipeline-focused sessions for both antimicrobials and diagnostics. If you have a product that is pre-approval (or only very recently approved), you are invited to present at one of these sessions. Here are the details on how to apply to participate: “Industry partners
Dear All (and with a wonkish alert!), The idea of more (and better) vaccines to prevent (or even be part of treating) bacterial infections has long intrigued. We certainly do have several good bacterial vaccines, but why not more? As part of this ongoing discussion, I really enjoyed a paper that came out back in
Dear All (unapologetically wonkish … very important material!), Let’s set the scene today by considering two quotes: Prosaic: “The successful treatment of patients with cancer has long depended on the capacity to manage infectious complications.” (Shropshire 2025, cited below) Blunt translation: “Your cancer will be controlled, but then you may die of infection.” (Abdul Ghafur,