Government Action

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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Implementation Handbook on National Action Plans from WHO

Dear All, Continuing on the theme of helping countries develop their own national action plans, WHO released the “WHO implementation handbook for national action plans on antimicrobial resistance: guidance for the human health sector“. The handbook has some great infographics like the one below and will shortly be translated into French, Spanish, and Russian. There

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FORWARD Act, PREVENT Act, new NIAID RFP!

Dear All, Our US government colleagues have been busy! Three things back-to-back: First, the FORWARD Act (Finding Orphan-disease Remedies With Antifungal Research and Development Act of 2022”) was introduced in the US Senate on 13 Jan 2021 as S.3498 by Sens. Kelly, Sinema, and Feinstein. You’ve got to admire the acronymics! The Senate bill is the

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Pull incentives in the EU / Statements by Commissioner Kyriakides

Dear All (and note the related 28 Nov 2020 newsletter), Stella Kyriakides, the European Commissioner for Health and Food Safety, made some really interesting statements before the European Parliament’s health committee (ENVI) on Thursday of last week (22 April). Per this Exchange of Views on the EP’s multimedia center and this news report, here are some

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Reform of EU pharmaceutical legislation: Public consultation now open!

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

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“Astonishing mismatch”: Market potential of AMR tools vs. patient needs

Dear All, We have today an excellent report from the Global AMR R&D Hub entitled “Estimating Global Patient Needs and Market Potential for Priority Health Technologies Addressing Antimicrobial Resistance.” Both the bottom line and the key message of the report are clearly stated in the Preface: “… we hope that by showing the astonishing mismatch

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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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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

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