Government Action

EMA-FDA-PMDA action + Podcasts (CDD, Pew) + NEJM on non-inferiority

Dear All: Several updates today, all on the theme of good things to know or share! First, EMA, FDA, and PMDA are continuing to meet and have released a summary of their third tripartite meeting. The key message is alignment: alignment on trial designs for key indications, alignment on pediatric programs, and alignment on single global development programs! This is

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European Commission: Proposed Pull incentives!

Note: Be sure to see the forward calendar: there is a webinar on 9 May during which Mark McClellan will speak with Sen. Todd Young, co-sponsor of the recently reintroduced PASTEUR Act! Don’t miss it! Dear All, For today’s note, we will be doing a dive into some very exciting AMR-related proposed legislation released by

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Draft EMA antibacterial guidance: Analysis

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

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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,

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Lancet: 10-20-30 targets to address AMR by 2030

Note: Since sending the 18 May 2024 newsletter about the new WHO bacterial PPL, I have learned of a 2021 PPL from Japan! Please see the Bugs & Drugs webpage to get an updated .pptx or .pdf summarizing all 8 PPLs published to date.Dear All (wonkish alert … but definitely worth the effort! Refill your coffee!),Ramanan Laxminarayan and about

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Japan Pulls for Pandemic Preparedness: Nikkei FT Conference

Dear All, As we discussed in the 5 Nov 2023 “Pulling for Pandemic Preparedness” newsletter, AMR is a global threat: resistance in one part of the world can suddenly appear in your hospital. As an example of that sort of threat, Jason Gale’s 30 Oct 2023 newsletter entitled “Untreatable Typhoid Should Make You Worry About Poop”

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Fireside Chat with BARDA’s Branch Chief for Antimicrobials

Note: Be sure to take advantage of the BARDA Industry Day(s) event that occurs Monday-Tuesday of this coming week … see newsletter and forward calendar for details. Dear All, In what could be called Part 2 of Excellent 2023 ASM/ESCMID Talks (read the newsletter on Jen Cohen’s talk on how manufacturing underpins both access and

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New UK 5-year AMR plan: Subscription model details!

Dear All, Today is a newsletter double-header! Coming hard on the heels of the opportunity to support an ESCMID petition to UNGA 2024, the UK today released the details of its next five-year action plan. Excitingly for this audience, there is an updated roadmap for the UK’s next steps in its subscription model. Here are

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