Government Action

Sign a letter in support of antifungal R&D … in support of PASTEUR!

Dear All: As you know if you are a regular reader of this newsletter, I think that creation of suitable Pull incentives by passage of the PASTEUR Act in the United States is key to building a vibrant pipeline of products to address the international problem of AMR. I’ve also written recently about the FORWARD Act

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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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New UK 5-year AMR plan: Subscription model details!

Dear All, Today is a newsletter double-header! Coming hard on the heels of the opportunity to support an ESCMID petition to UNGA 2024, the UK today released the details of its next five-year action plan. Excitingly for this audience, there is an updated roadmap for the UK’s next steps in its subscription model. Here are

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Ready, set, go! AMR appropriations in the US FY2025 budget

Dear All, If you follow US politics, you will know that the USG (US Government) is beginning its appropriations process for FY2025 (Federal Year 2025). In preparation, a letter calling for AMR-related funding has been drafted by the Infectious Diseases Society of America (IDSA), AdvaMedDx, American Society for Microbiology (ASM), Association for Professionals in Infection Control

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Call for Pull: Swiss Roundtable on Antibiotics

Dear All, To end the week, we have a really lovely paper from the Swiss Roundtable on Antibiotics (a multidisciplinary, non-profit Swiss association). Here are the links you need: The new (25 March 2024) paper entitled “Effective antibiotics for the Swiss health care system: today and in the future.” A prior (7 Feb 2023) paper

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EMA Concept Paper: Guidance on manufacturing of phage products

Dear All, This one slipped past me until just now … EMA have released a concept paper entitled “Development and manufacture of human medicinal products specifically designed for phage therapy – Scientific guideline.” Here are the links you need: Overview webpage regarding the concept paper The 4-page concept paper itself A parallel guidance on phage for veterinary purposes

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A new BAA, now from FDA!

Update on 11 October 2023: The annual BARDA Industry Day is 13-14 November 2023! You can attend virtually or in person at the Grand Hyatt Washington, DC. Click here for more details! Dear All, Hot on the heels of the BAA from BARDA and from ARPA-H, we now have a Broad Agency Announcement from the FDA! There

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