This newsletter is part of a series — here are the links to Part 1, Part 3, and Part 4. Dear All (wonkish note alert!), The recent newsletter on chemicals, drugs, and halicin (link, see also a follow-up newsletter here) generated significant discussion and new insights that I thought I would share in a follow-up newsletter. Our
Dear All (wonkish alert … coffee up!), FDA held a workshop on 25 Sep 2020 on development of inhaled antifungal (AF) therapies with a focus on (i) therapies for allergic bronchopulmonary aspergillosis (ABPA) and severe asthma with fungal sensitization (SAFS), (ii) prophylaxis in lung transplantation, and (iii) adjunct therapy in invasive fungal lung infections (link to
Aside: If you’ve enjoyed the prior discussions of movies to inspire antibiotic R&D and very apropos given the theme of today’s newsletter, please check out the newly released 4-minute YouTube discussion of a scene from Master and Commander in which antibiotics could have saved a young man’s arm! Dear All (Wonkish alert! There’s a lot of
Dear All (wonkish alert, but the details are fascinating … and with thanks to Kevin Outterson for co-authoring!), Two related items of note for today. First, the PASTEUR Act was introduced today (press release from Rep. Doyle; press release from Rep. Ferguson) into the US House of Representatives by the bipartisan team of U.S. Representatives
Dear All (Wonkish alert! Coffee-up!), Today we have something special: A deep-dive into the future trajectory of AMR-related work developed by Wellcome Trust. The newly released report is here and there is a webinar discussing the report on Wednesday of this week (1500-16:00 GMT on 18 Nov 2020, go here to register). The back story
Dear All (wonkish but intended for everybody to read and absorb): 27 Jan 2021 update: This topic now has its own YouTube video! As the ideas here are VERY confusing, I suggest you make the time to watch the video, read the newsletter, and then watch the video one more time. I have yet to
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
Dear All (with thanks to Kevin as the lead author on this note and also with a wonkish note alert … refresh your coffee and settle in!), Several years ago, DRIVE-AB planted some seeds across Europe on reforming how we pay for antibiotics. As a consequence, we are seeing some hopeful sprouts in several countries: Previous newsletters
Dear All (with thanks to Kevin Outterson for co-authoring this newsletter), Last week’s announcement of the AMR Action Fund was both exciting and sobering: $1b from 20+ pharma companies to fund antibacterials through Phase II-III to approval, with a goal 2-4 high quality new agents by 2030. If you missed it, please go here to
Dear All (wonkish alert … the first 3 segments are non-wonkish but the last 2 are in the wonkish zone … titrate your plasma caffeine level appropriately), Part 1: FDA has recently released a draft guidance entitled Development of Anti-Infective Drug Products for the Pediatric Population (link). This timely guidance builds on related guidance documents
