R&D Insight

Clostridioides difficile / CARB-X Year 3 Annual Report / White House OSTP seeks input on the US Bioeconomy

Dear All, Committing serial email this afternoon… First, the note I just sent on FMT for Clostridium difficile (link) prompted comments that the organism is now called Clostridioides difficile. This name change slipped past me, I’ll admit! But it does seem a settled change … see this helpful editorial from May 2019 in Lancet ID for a summary of how the new

11 September 2019 No Comments

FDA public hearing on Fecal Microbiota Transplantation (FMT) to Treat Clostridium difficile

Dear All, On 4 Nov 2019 at their White Oak Campus, FDA will hold a public hearing from 9a-4p on fecal microbiota transplantation (FMT) to treat Clostridium difficile infections that are not response to standard therapies. Go here for the online FR notice and here for the .pdf version. The background on this topic goes back several years and is well

11 September 2019 No Comments

Novo REPAIR’s 2019 US-Canada funding round is open; Global AMR R&D hub seeks your input

Dear All, Two time-limited opportunities have been announced in the past few days. First, the Novo REPAIR Impact Fund has opened its 2019 US-Canada-focused investment round. Non-confidential proposals are due by 11 Oct … go here for details. Note that you need to dig all the way to the bottom of the web page to find the information.

6 September 2019 No Comments

Alan Carr’s Sep 2019 Antibacterial-Antifungal Update; Pews’ updated pipeline review

Dear All, First, Alan Carr’s Sep 2019 Antibiotic and Antifungal Update (link) is, as usual, required reading (see also this prior blog). Key highlights: He provides an updated by-month sales report from Jan 2016 through Jul 2019 of all products approved since 2009. Sadly, it remains the case that only 4 drugs have sold more than $100m in the

6 September 2019 No Comments

WHO wants your input on its draft TPPs for needed antibacterial agents

Dear All, Addendum: This project ultimately led to publishing in May 2020 of a set of TPPs for enteric fever, gonorrhea, neonatal sepsis, and urinary tract infections as guides for developers. You can find those TPPs at https://www.who.int/publications/i/item/9789240003897. WHO has developed a set of draft TPPs (target product profiles) for needed new antibiotics. As part of the

1 September 2019 No Comments

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

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