Government Action

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

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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

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21st Century Cures v2.0 — PASTEUR Act is embedded!

Dear All, Building on the success of the 21st Century Cures Act passed in 2016 and springboarding from a concept paper published in Science, U.S. Reps. Diana DeGette, D-Colorado, and Fred Upton, R-Michigan, have today introduced the 21st Century Cures Act v2.0! Here are the links you need: Discussion draft of the Cures 2.0 bill Cures 2.0

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US National Action Plan for Combatting AMR: 2020-25 update!

Dear All (and with thanks to Kevin Outterson for doing the heavy lifting on this note), As you may recall, the US National Action Plan for Combatting Antimicrobial Resistant Bacteria (US NAP CARB) was launched in 2015 on the heels of the 2013 CDC report on antimicrobial threats (link to that report) and is/was a

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FDA and EMA regulatory updates / Fireside chat during the 4th AMR Conference

Dear All (lots and lots of wonkish detail here, be sure your blood caffeine level is adequate!), During the 24-28 Aug 2020 BEAM Alliance-sponsored AMR Conference (go here or see below my signature for more), I had the opportunity on 27 August to chat with Sumati Nambiar (FDA) and Marco Cavaleri (EMA) about ongoing regulatory activities. The

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EMA Network Strategy to 2025: Action on AMR / Comments due 4 Sep

Dear All, We learned today during the BEAM AMR conference (link) that EMA released a call on 7 June 202 for comments on their draft Network Strategy to 2025 that considers how “the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges

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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

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NHS England Antibiotic Procurement Pilot: Call for applications!

Dear All, As has been discussed in recent newsletters (link), the UK National Institute for Health and Care Excellence (NICE) and NHS England launched a joint project July 2019 to test a payment model for antibiotic products, based on a product’s value to the NHS, rather than how much is used. This goal of the

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Horizon Europe 2021-2027: Initial AMR-focused calls now posted!

Dear All (and with thanks to Arjon van Hengel for co-authoring), As was discussed in newsletters dated 28 Nov 2020 (a general announcement) and 29 Apr 2021 (comments by Stella Kyriakides), the EU has announced an ambitious Pharmaceutical Strategy with initiatives that includes development of Pull incentives for antimicrobials among a number of other topics (see the 28

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