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MHRA Seeks Chief Medical and Scientific Officer
Dear All, I have learned that UK’s MHRA (Medicines & Healthcare products Regulatory Agency) is recruiting for the role of Chief ...
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WHO: Draft TPPs for MDR bacterial infections
Dear All, Back in 2019-2020, WHO developed a set of TPPs (TPP = Target Product Profile = A description of the ...
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Italy initiates its national pull Incentive!
Dear All (and with thanks to Damiano for taking the lead on this newsletter), We wrote previously in (i) the 7 ...
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BARDA RFP: Antibiotic for HABP/VABP or Bloodstream Infection
Dear All, BARDA have published an RFP (Request for Proposals) under which it would support clinical development and then stockpiling ...
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Vaccination to prevent AMR: Insights from Wellcome
Dear All (and with thanks to Vega Masignani for co-authoring this newsletter), Waaaay back in 2019 (pre-COVID … remember that?), ...
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The threat of mirror bacteria: Ongoing conversations
Dear All, I wrote in a 12 Dec 2024 newsletter (“Mirror Bacteria: An AMR threat of unprecedented magnitude”) about the ...
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Updated FDA Q&A on Antibacterials for Unmet Medical Need
Dear All, An updated version of FDA’s very helpful Q&A entitled “Antibacterial Therapies for Patients With an Unmet Medical Need ...
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UNGA 2024 action: Establishing an Independent Panel on Evidence for Action (IPEA)
Dear All, Referring back to the actions planned following the 2024 UNGA HLM on AMR (UN General Assembly High-Level Meeting ...
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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 ...
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Extending STEDI to diagnostics: STRIDES
Dear All (and with thanks to Betsy Trainor for co-authoring), The idea of the STEDI values of an antibiotic (its ...
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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 ...
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D-Day: Churchill (1944) → WHO Pandemic Agreement and the Hamburg Statement (2025)
Dear All, D-Day and the momentous Normandy landings were 81 years ago today. In a marvelous new article on bbc.com (and ...
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FDA Listening Sessions for CEOs, CMOs, or heads of R&D
Dear All, Pushing this one out as a direct quote from the online materials posted yesterday by FDA. Looks interesting! All ...
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IDWeek 2025: Present your novel antimicrobial or diagnostic
Dear All, As in previous years (27 Mar 2024 newsletter), IDWeek 2025 will feature pipeline-focused sessions for both antimicrobials and ...
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Vaccine development: Polytheism vs. Monotheism
Dear All (and with a wonkish alert!), The idea of more (and better) vaccines to prevent (or even be part ...
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Impact of AMR on cancer therapy
Dear All (unapologetically wonkish … very important material!), Let’s set the scene today by considering two quotes: Prosaic: “The successful ...
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Evolving the idea of DTR (Difficult-to-Treat Resistance) to include antibiotic access
Dear All (wonkish alert … lots of details here … take your time and absorb it all!), I’ve written several ...
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Vivli’s 2025 AMR Surveillance Data Challenge
Dear All, We’ve previously discussed the availability of large surveillance datasets from the Vivli AMR Register. In particular, you should review Patricia ...
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Manufacturing underpins access in LMICs: An update on cefiderocol
Dear All, No one is safe until we’re all safe! In the 7 April 2025 newsletter on antibiotic access (“UNSLAP: You ...
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Most current global summary of Pull incentives
Dear All, I was recently asked about a ready summary of the current state of play of Pull incentives around ...
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