Government Action Archives • Page 10 of 11 • AMR.Solutions

UK Antibiotic Subscription Pilot implies Pull Incentive of up to $4b across the G20

Note that there is a follow-up newsletter that covers a post-webinar FAQ. After reading this newsletter as introduction, please go here for the follow-up newsletter. Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Prior newsletters have covered the antibiotic evaluation procurement pilot being run by NICE and NHS England (go here for the

29 March 2020 No Comments

UK Antibiotic Subscription Pilot: Post-webinar FAQ document

Dear All, Kevin Outterson and I recently shared our analysis of the NICE/NHS England pilot of an antibiotic procurement subscription model (link to that newsletter). The NICE/NHS team have now released a post-webinar FAQ document. Here is the link to the document … and I’ve also added the link to the initial webpage (cited just above) discussing

3 April 2020 No Comments

NHS England antibiotic procurement pilot project: Update webinar on 25 Mar 2020

Dear All, This email was just today received from the team leading the NHS England antibiotic procurement project (go here for a prior newsletter describing the project): Dear Stakeholders, In November 2019, we held a stakeholder webinar to share our response to the comments raised in targeted engagement and to outline proposals for the procurement process.

11 March 2020 No Comments

COVID-19 R&D support: US (FDA, BARDA, NIAID), Europe (EMA, EC), and globally (BioCentury resource hub)

Dear All, And now for a change from our usually scheduled content! As you might expect, major agencies in the US (FDA, BARDA, NIAID) and Europe (EMA, EC, national agencies) are actively supporting the global R&D response to COVID-19. In addition, global consortia are appearing and BioCentury has provided both a newsletter on this as well

16 April 2020 No Comments

European Parliament Resolution on Access to (and value of) Medicines

Dear All: The attached EU Parliament resolution on Access to Medicines was released today. Broadly, it calls for greater transparency in price setting for medicines and for harmonization of HTA processes. Along the way, AMR gets a couple of specific mentions as does the Adaptive Pathway concept that provides some of the logic behind registering antibiotics with

2 March 2017 No Comments

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

21 November 2017 No Comments

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

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