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, 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, 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
Dear All, I am pleased to learn that BARDA is holding a one-day innovation symposium on 20 Nov 2025. As you know, BARDA is a consistently creative funder of diverse medical countermeasures, including new antibiotics. For background, see these prior newsletters: 22 Jul 2025 newsletter: “BARDA RFP: Antibiotic for HABP/VABP or Bloodstream Infection” 5 Nov
Dear All, I have learned that UK’s MHRA (Medicines & Healthcare products Regulatory Agency) is recruiting for the role of Chief Medical and Scientific Officer. As you would expect, the role is very senior! The person in the role will: Represent the MHRA across the medical and scientific communities Act as a senior advocate for evidence-based, effective
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