R&D Insight

India bans food ag use of colistin / CDC updates report on US use of antibiotics

Dear All, Two mid-week notes: First (and huge!), India’s Ministry of Health issued a notification last week prohibiting the “manufacture, sale and distribution of the drug colistin and its formulations for food-producing animals, poultry, aqua farming and animal feed supplements” because such use is “likely to involve risk to human beings.” You can find this on multiple

22 August 2019 No Comments

Your vote counts! Support the UN proposal for an AMR-focused Sustainable Development Goal (SDG) Indicator

Dear All, Your vote counts! The UN’s Inter-Agency and Expert Group on Sustainable Development Goal Indicators (IAEG-SDGs) is conducting an open consultation on proposals it is considering including in the 2020 Comprehensive Review and is seeking the global community’s comments on these proposals (link to summary web page). The 17 SDGs were adopted in 2015 and are really driving

19 August 2019 No Comments

Non-traditional antibiotics: A pipeline review and an analysis of key development challenges

Dear All, Non-traditional alternatives to antibiotics have excited a lot of interest in the past few years but we’ve seen relatively few of these progress in a meaningful way (go here for Pew’s recent survey of the development landscape). Providing insights into the challenges of this area, two valuable and complementary articles on non-traditional antibiotics have recently

6 August 2019 No Comments

Clever pipeline visualization from Pew + New guidance documents from FDA

Dear All, Two very brief notes today… First, Pew Trusts continues to work to provide ways to understand the antibiotic pipeline. Building on their ongoing surveys (link), their latest contribution is a clever visualization tool that shows how antibiotics have moved forwards, backwards, and/or stopped during the period 2014-2018. Go here to see it in action and prepare to

5 August 2019 No Comments

Public meeting on the LPAD Pathway: Post-meeting thoughts (wonkish)

Long and wonkish note alert — please refresh your coffee before you start reading! Dear All: I was able to attend and speak at the 12 July 2019 Public Meeting organized by FDA on the LPAD (Limited Population Antibacterial and Antifungal Drug) pathway. The current draft guidance is here and the meeting agenda is found here. The meeting

22 July 2019 No Comments

CMS Administrator Seema Verma: “Volume-based incentives undervalue antibiotics”

Dear All, In a marvelous series of tweets, Seema Verma (current Administrator of the US Centers for Medicare and Medicaid Services) today said the following (emphasis is mine): Not-so-fun fact of the day: Most classes of antibiotics prescribed to #Medicare beneficiaries were discovered long ago- before they were even born. #FactFriday #DYK Over time, pathogens have

12 July 2019 No Comments

The UK jumps in with a subscription model for antibiotics!

Dear All: We had hints back in January that this was coming (see this post), but now it is really happening! In brief, UK’s NHS will test the world’s first subscription-style payment model in which payments delinked from volume are used to incentivise pharmaceutical companies to develop new drugs for resistant infections. Below my signature, I’ve

9 July 2019 No Comments

AMR stays on the G20’s to-do list with calls for Push and Pull mechanisms

Aside: Please look closely at the forward calendar. In addition to two new webinars from GARDP’s REVIVE project, there is a meeting in Thailand in December that focuses on alternatives to antibiotics. I’m told that the program is primarily focused on veterinary and agricultural uses, but previous year’s attendees have found the discussion to have broad application

5 July 2019 No Comments

An apple a day (used to) keep the doctor away

Dear All: OK … enough with bad news, at least for today. In today’s edition of XKCD (link), we learn about resistance to apples and the need to use good apple stewardship. Image reproduced with permission from https://xkcd.com/2161/ If you don’t read XKCD, you should! All best wishes, –jr John H. Rex, MD | Chief Medical

11 June 2019 No Comments

FDA Workshop: Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes

Dear All: The idea of using real-world evidence (RWE) as a way to support development of novel agents (including antibiotics!) has always intrigued. As you may recall, the 21st Century Cures Act (Cures Act) gave FDA a mandate to evaluate the potential use of RWE to support drug approval. There was a workshop on this on

10 June 2019 No Comments

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