Government Action Archives • AMR.Solutions

Updates from EMA, FDA, and UK NICE at the 6-8 Sep 2017 ASM-ESCMID Antibiotic Development Conference

Dear All: On Wednesday 6 Sep at the ASM-ESCMID Conference on Antibacterial Development, we heard 3 superb back-to-back talks on the evolving regulatory and health technology assessment (HTA) landscape. The speakers (Marco Cavaleri, PhD, Head of Anti-Infectives and Vaccines, EMA; Sumati Nambiar, MD, Director, Division of Anti-infective Products, FDA; and Colm Leonard, MD, Consultant Clinical Adviser,

8 September 2017 No Comments

PASTEUR Act re-introduced and levels up antimicrobial economics for strong innovation!

Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Woot, woot! Woot, woot! US Senators Michael Bennet (D-Colo.) and Todd Young (R-Ind.) and Representatives Mike Doyle (D-Pa.) and Drew Ferguson (R-Ga.) have today reintroduced the PASTEUR (Pioneering Antimicrobial Subscriptions to End Up surging Resistance) Act! Here are the links you need: The text of

16 June 2021 No Comments

G7 Health ministers 3-4 June communique / Implications for choosing wisely

Note: Newsletter now updated to include the communique from the G7 Finance Ministers! Dear All, The G7 met in Oxford this past week and we now have communiques released from by both the Health and Finance Ministers. Let’s look first at the two fascinating statements from the Health Ministers: A general communique that includes multiple

5 June 2021 No Comments

Global Health Security: G7, BARDA Ventures, excellent ATMF report on saving small companies!

Dear All, On the theme of global health security, today’s note covers 3 exciting, overlapping items. Here we go… First, the G7 leaders have agreed to sign the Carbis Bay Declaration covering global health, economic stability, climate and more. Specifically related to health in a section entitled “End the pandemic and prepare for the future”, we have

14 June 2021 No Comments

Ex-US new antibiotic access: Multi-year delays, even in Europe!

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

19 August 2021 No Comments

G7 Finance Ministers call for Pull; US-specific text cites PASTEUR and a PASTEUR backup plan!

https://www.youtube.com/watch?v=f0-xt3FrAGU&ab_channel=AMR.SolutionswithDr.JohnRex Dear All, VERY exciting news on the Pull incentive front: The G7 Finance Ministers have released a statement on Actions to Support Antibiotic Development, aiming to strengthen G7 preparedness against the “silent pandemic” of antimicrobial resistance. Implicitly, this is a statement that is agreed and endorsed by the political leadership of each country —

14 December 2021 No Comments

Updated ATMF AMR Benchmark! Signs of progress but access lags

Dear All (and with thanks to ATMF’s Damiano de Felice for co-authoring this newsletter), Last week, the team at ATMF (Access to Medicine Foundation) released a 3rd update to the AMR Benchmark series that they started in 2018. For those not familiar with the ATMF, its independent analyses (all its funding is from governments or private

23 November 2021 No Comments

Notable reports: Incentives (WHO, AMR Hub); Strategy (BARDA); Capacity Building (UK Fleming Fund, US CDC)

Dear All, Four big reports have recently been released and are very much worth reviewing. First, the Global AMR R&D Hub and the WHO AMR Team have written a report entitled “Incentivising the development of new antibacterial treatments“. This report is a response to a 2021 request by the G7 Finance Ministers for a report on

4 June 2022 No Comments

Appropriate pull incentive for new antibacterials: $2.2-4.8b for full delinkage

Dear All (and with thanks to Kevin Outterson for authoring this newsletter), Readers of these newsletters will need few reminders of why pull incentives are critical to restoring the R&D ecosystem for antibacterials. (But if you are new to the issue, Andrew Jack’s 5-minute video explainer is a great start; see also this annotated list

1 November 2021 No Comments

WHO Essential Medicines List (EML): Antibiotic Book promotes AWaReness

Dear All, WHO have released for consultation an updated draft of their EML (Essential Medicines List) Antibiotic handbook. For those not familiar with it, WHO’s EML (now in its 22nd edition!) provides a guide to a core set of medicines that every country should have. The antibiotic-focused version does this for antibiotics and then adds

21 November 2021 No Comments

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