Dear All, As was discussed in these prior newsletters, the EU has announced an ambitious Pharmaceutical Strategy with initiatives that include development of Pull incentives for antimicrobials among a number of other topics (see the 28 Nov 2020 newsletter for the full list): 28 Nov 2020 (a general announcement) 29 Apr 2021 (comments by Stella Kyriakides) 24 Jun 2021 (RFPs
Dear All: I’ve written a lot about the need for pull incentives, preferably delinked (some papers to read, comments by TATFAR, highlights from Davos 2018, and the UK commits to trying delinkage). Now, I am delighted to report that a really serious effort is underway in the US to make something happen during the 116th Congress. The essential document can be
Dear All: Dated 19 Dec 2018 and marked as released for public consultation on 14 Jan 2019, EMA has posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft antibacterial guidance document. I have not yet had a chance to study in detail and will
Dear All: I wrote previously that EMA posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft antibacterial guidance document. I’ve now had a chance to read it in detail and thought I would share my thoughts as a way to provoke discussion. As a reminder, the
Dear All: Wow! It’s happened! As reported this morning in The Times and The Guardian among others, the UK will announce at Davos that it is committing to a 20-year vision and initial 5-year plan to combat AMR. The plan includes actions to reduce infection rates, to reduce antibiotic use, and most importantly for this audience to find a path to delinked
Dear All (and note the related 29 Apr 2021 newsletter), As was discussed at length in the recent Wellcome Trust-sponsored analysis of the AMR-related needs for the coming decades (see this newsletter), it is critical that we build and maintain momentum around AMR-focused work. As a big part of that revolves around being visible in
Dear All: Also appearing today are two valuable opportunities to comment on key global strategy documents. I do hope each of you can make time to look at these materials and consider sending in your thoughts — it really does make a difference when central leadership groups hear from a broad array of stakeholders! First, EMA has
Dear All (this newsletter experiments with an Executive Summary/Details format; let me know what you think), (Executive Summary) As a further support for implementation of recommendations from the UN Interagency Coordination Group on Antimicrobial Resistance (IACG AMR), the Tripartite Plus (WHO-FAO-OIE-UNEP) are seeking to create a Partnership Platform that will “engage institutions representing states, markets and
Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Post-newsletter addendum: A slide deck that summarizes the data from the paper is now available. We talked in a 22 Mar 2021 newsletter about ensuring access to new antibiotics and you should take a moment to refresh your memory of its discussions of
Dear All, Building on the success of the 21st Century Cures Act passed in 2016 and springboarding from a concept paper published in Science, U.S. Reps. Diana DeGette, D-Colorado, and Fred Upton, R-Michigan, have today introduced the 21st Century Cures Act v2.0! Here are the links you need: Discussion draft of the Cures 2.0 bill Cures 2.0
