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
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
Dear All, I was fascinated to see Mayo Clinic’s Global Bridges Healthcare Alliance release an RFP on 21 Oct entitled “Antimicrobial Stewardship (AMS) Programs to Address Health Inequities arising from Socioeconomic Disparities in USA, Europe, Japan, South Korea, Australia and New Zealand.” The RFP is supported by a grant from Pfizer and seeks to “… solicit programs that have
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
Dear All, On 6 Jan 2022, we had the announcement of the creation of in France of the ARPEGE consortium (AppRoche théraPeutique Economique & diaGnostique de l’antibiorésistancE) or “Economic, diagnostic and therapeutic approach to antibiotic resistance.” Somebody definitely had fun with that acronym! Here’s what you need to know: The French government is providing €9m of
https://www.youtube.com/watch?v=f0-xt3FrAGU&ab_channel=AMR.SolutionswithDr.JohnRex Dear All, VERY exciting news on the Pull incentive front: The G7 Finance Ministers have released a statement on Actions to Support Antibiotic Development, aiming to strengthen G7 preparedness against the “silent pandemic” of antimicrobial resistance. Implicitly, this is a statement that is agreed and endorsed by the political leadership of each country —
Dear All (and with thanks to ATMF’s Damiano de Felice for co-authoring this newsletter), Last week, the team at ATMF (Access to Medicine Foundation) released a 3rd update to the AMR Benchmark series that they started in 2018. For those not familiar with the ATMF, its independent analyses (all its funding is from governments or private
Dear All, WHO have released for consultation an updated draft of their EML (Essential Medicines List) Antibiotic handbook. For those not familiar with it, WHO’s EML (now in its 22nd edition!) provides a guide to a core set of medicines that every country should have. The antibiotic-focused version does this for antibiotics and then adds
Dear All (and with thanks to Kevin Outterson for authoring this newsletter), Readers of these newsletters will need few reminders of why pull incentives are critical to restoring the R&D ecosystem for antibacterials. (But if you are new to the issue, Andrew Jack’s 5-minute video explainer is a great start; see also this annotated list
Dear All, WHO continues on their streak of seeking support for their AMR-related work! Today we have a posting by the Tripartite Joint Secretariat on Antimicrobial Resistance (AMR) of a consultancy opening for an 11-month project that would support development of multisectoral guidance(s) on development and strengthening of the coordination mechanisms and governance structures for addressing AMR. Full details
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