Government Action

BARDA seeks deep insight on antibacterials near/beyond end-of-Phase 2

Dear All, BARDA has released a fascinating Sources Sought Notice (SSN) seeking data on antibacterials near, at, or beyond Phase 2. I’ve never seen one before, but an SSN is market research with which BARDA will “collect feedback from current and prospective antibiotic development partners” that will “serve as continued market research for potential future acquisitions

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Jan 2025 PACCARB meeting cancelled as new administration takes the reins

Dear All, Sadly, I must report that the 27th meeting of PACCARB (the US Presidential Advisory Council on Combatting Antibiotic-Resistant Bacteria) planned for 28-29 Jan 2025 has been cancelled “as the new Administration considers its plan for managing federal policy and public communications.” This 22 Jan 2025 article in the New York Times provides additional details

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HLM on AMR at UNGA: The end of the beginning

Aside: Please refer to our UNGA 2024 webpage for additional post-HLM notes and updates. 28 Oct 2024 addendum and another way to get a view of the day: Hosted by Cesar Arias, Editor-in-Chief of Antimicrobial Agents and Therapy, John and Prabha Fernandes recorded a podcast discussion of the HLM.  Dear All (and with thanks to Damiano

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MHRA compilation of regulatory guidance on phage products

Dear All, Attention phage developers — the UK MHRA have compiled all their regulatory guidance for phage into one convenient location!  The overview webpage gives these comments: https://www.gov.uk/government/publications/regulatory-considerations-for-therapeutic-use-of-bacteriophages-in-the-uk “The MHRA has compiled a document containing all the relevant regulatory guidance pertinent to the development of phage therapeutic products. “Regulatory agencies and organisations have produced documentation

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Pull incentives in Europe: Next legislative steps

Dear All (Deeply wonkish alert! Settle in! Great stuff here!): For today, we have a deep dive into the ongoing work in the EU to develop a set of realistic pull incentives using our best understanding to date of realistic choices. If the idea of Pull (and Push) is new to you, please check out

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UK Pull (“Netflix-like”) pilot: STEDI-based QALY value of new antibiotics implies societal value > 10m GBP/year!

Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), We’ve written before about the UK’s “Netflix” pilot antibiotic Pull incentive in which England leads the way on showing how it plans to provide its fair share of a global antibacterial Pull incentive (for background on Pull incentives, see this superb 5-minute video explainer). In

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Ex-US new antibiotic access: Multi-year delays, even in Europe!

Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Post-newsletter addendum: A slide deck that summarizes the data from the paper is now available. We talked in a 22 Mar 2021 newsletter about ensuring access to new antibiotics and you should take a moment to refresh your memory of its discussions of

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