Dear All: As discussed in prior newsletters, BARDA is constantly working to ensure it has adequate medical countermeasures (MCMs) for a variety of possible threats. The titles of these newsletters give a quick review of their recent work — note in particular the Fireside Chat and the newsletter discussing the ongoing BAA (Broad Agency Announcement)
Dear All, No, EMA has not decided to set up shop on the beach! Rather, the point of this newsletter is that I heard a fascinating talk on the idea of “regulatory sandboxes” during the recent BEAM-AMR meeting. I had not previously heard of this idea, but it turns out that the concept of regulatory sandbox
Dear All, I’m delighted to be able to say that PASTEUR 2026 was (re)introduced into the US Congress this week! It’s an improved version relative to the version introduced into the prior 3 sessions of the US Congress (see below for discussion of that), so I think we can safely call it “PASTEUR v2.0” as
Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), We’ve written before about the UK’s “Netflix” pilot antibiotic Pull incentive in which England leads the way on showing how it plans to provide its fair share of a global antibacterial Pull incentive (for background on Pull incentives, see this superb 5-minute video explainer). In
Dear All (with thanks to Kevin for leading on this newsletter and with a wonkish / long-read alert on this email … settle in for the ride!), Great news from TEAM UK! As of 12 August, the UK Subscription Program is no longer a pilot but is fully operational with an initial application deadline of
Dear All, In a report entitled Understanding the Antibiotic Manufacturing Ecosystem: A view of global supply chains, pressure points, and implications for antimicrobial resistance response, the Boston Consulting Group and Wellcome Trust have examined at length the questions of (i) how the #FireExtinguishersOfMedicine are made and (ii) how they can be made with the least impact
This is the first of a 5-part newsletter series. There is 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, a 4th newsletter (27 Jan 2024) containing some additional resources, and a fifth newsletter (11
This is the third 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 4th newsletter (27 Jan 2024) containing some additional resources, and a fifth newsletter (11 Oct 2024) about the EPA’s collaborative framework for evaluating the AMR risks of antibacterial and antifungal
Dear All, There are more details yet to come, but the EU Council (“the Council”) and the EU Parliament (EP) yesterday announced an agreement on the update to the EU General Pharmaceutical Legislation that includes transferable exclusivity vouchers (TEVs or TEEVs, depending on your preferred abbreviation). Here’s the key text from the EP’s press release:
Dear All (and with thanks to Frédéric Peyrane for leading on this newsletter): You will know that we eagerly watching the work in the EU on implementing a set of pull incentives based on use of ‘transferable data exclusivity voucher’ (TEV), also referred to as a ‘transferable exclusivity extension voucher’ (TEEV). In brief, the concept is that a TEEV