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, Sadly, I must report that the 27th meeting of PACCARB (the US Presidential Advisory Council on Combatting Antibiotic-Resistant Bacteria) planned for 28-29 Jan 2025 has been cancelled “as the new Administration considers its plan for managing federal policy and public communications.” This 22 Jan 2025 article in the New York Times provides additional details
Dear All (wonkish but intended for everybody to read and absorb): 27 Jan 2021 update: This topic now has its own YouTube video! As the ideas here are VERY confusing, I suggest you make the time to watch the video, read the newsletter, and then watch the video one more time. I have yet to
Dear All (Wonkish alert! Get some coffee and settle in!), Almost in parallel, EMA and FDA have released updates to key antibacterial guidance documents! Here are the links you’ll need and I’ve highlighted the key documents. To go deeper, you’ll need to pick through everything and I provide a tour further below in this newsletter: EMA’s
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 (and with thanks to Kevin Outterson for co-authoring this newsletter), The recent discussions of the NICE/NHS England pilot subscription model (detailed newsletter plus follow-up FAQ newsletter) and a new paper by Chantal Morel and colleagues on the idea of an Antibiotic Susceptibility Bonus (ASB, link) bring to the fore the question of how to value any given
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
Update: There is a 14 April 2025 follow-up to this newsletter. Dear All, Prompted by an excellent talk by GARDP’s Jennifer Cohn at last week’s ASM-ESCMID Developer’s conference, today I’d like to pull together several threads showing how responsible manufacturing and access are intertwined. (And if you missed the ASM-ESCMID meeting, you missed some great
Dear All (wonkish alert … lots of details here … take your time and absorb it all!), I’ve written several times about the concept of DTR, or Difficult-to-Treat resistance, that was proposed in 2018 by Kadri et al. Today we will consider an important update from Kadri and colleagues in which the idea of DTR