Government Action Archives • Page 10 of 11 • 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

The UK jumps in with a subscription model for antibiotics!

Dear All: We had hints back in January that this was coming (see this post), but now it is really happening! In brief, UK’s NHS will test the world’s first subscription-style payment model in which payments delinked from volume are used to incentivise pharmaceutical companies to develop new drugs for resistant infections. Below my signature, I’ve

9 July 2019 No Comments

Updated EMA antibacterial guidance: Draft released for public consultation

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

17 January 2019 No Comments

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

25 January 2019 No Comments

Let’s make a pull incentive happen in the US during the 116th Congress!

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

7 February 2019 No Comments

Two reports on the economics of AMR: UK Parliament, US National Academy of Science

Dear All: Two links to share today. First, we have a report to the UK House of Commons by their Health and Social Care Committee. This is a well-written summary of the core problem, the economic challenge for pharma, and the varied issues around resistance in human health, animal health, and the environment. Relevant to this community, we

3 November 2018 No Comments

EU Joint Action on AMR & Health-Care Associated Infections (EU-JAMRAI): Passing the DRIVE-AB torch?

Dear All: Recently announced is a new EU Joint Action on Antimicrobial Resistance (AMR) & Health-Care Associated Infections (HCAI). Its acronym is EU-JAMRAI and the website is https://eu-jamrai.eu/. Joint actions are a common tool for coordinating implementation activities across Europe. EU-JAMRAI actually started in September 2017 and will run for three years but it is really

20 March 2018 No Comments

Concept papers for comment: EMA Antibacterial Guidance + IACG global action action

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

19 June 2018 No Comments

The UK commits to a delinked antibiotic purchase model!

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

24 January 2019 No Comments

Your vote counts! Support the UN proposal for an AMR-focused Sustainable Development Goal (SDG) Indicator

Dear All, Your vote counts! The UN’s Inter-Agency and Expert Group on Sustainable Development Goal Indicators (IAEG-SDGs) is conducting an open consultation on proposals it is considering including in the 2020 Comprehensive Review and is seeking the global community’s comments on these proposals (link to summary web page). The 17 SDGs were adopted in 2015 and are really driving

19 August 2019 No Comments

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