R&D Insight

FDA workshop: Revising the process for importance-ranking of human antimicrobials to guide their use in animals

Dear All, FDA have announced that they will hold a virtual public workshop on 16 Nov 2020 (9.30a-4.00p EST) entitled “Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.” Go here for the FR notice, here for extended details, including registration, and here for

12 October 2020 No Comments

US National Action Plan for Combatting AMR: 2020-25 update!

Dear All (and with thanks to Kevin Outterson for doing the heavy lifting on this note), As you may recall, the US National Action Plan for Combatting Antimicrobial Resistant Bacteria (US NAP CARB) was launched in 2015 on the heels of the 2013 CDC report on antimicrobial threats (link to that report) and is/was a

9 October 2020 No Comments

WHO to create a Priority Pathogen List for Fungi! / RFP to build the list

Dear All, WHO have been thinking about the threat of resistant fungi as well as resistant bacteria. An initial discussion by a small working group on approaches to priority fungal pathogens (April 2020, here’s the link to the report) concluded that Candida auris; azole-resistant Candida spp., azole-resistant Aspergillus fumigatus, Cryptococcus neoformans (& C. gattii), Pneumocystis jirovecii, Mucorales, and potentially Histoplasmosis were

8 October 2020 No Comments

Help (re)validate WHO’s Priority Pathogens List and Essential Medicines List

Dear All, The Drug-Resistant Infections team at Wellcome Trust (link to their homepage) has launched a survey collecting data on current prescribing practices in low-, middle-, and high-income countries. The survey takes about 15 minutes and seeks answers to these questions: Does the WHO Pathogen Priority List (PPL, link), published in 2015, accurately reflect current pathogen

6 October 2020 No Comments

BARDA seeks information: Are you creating an antibiotic for Yersinia or other biothreat Gram-negatives?

Dear All, BARDA is interested in hearing from antibiotic developers about antibiotics which could be used under Emergency Use Authorization (EUA) or marketing authorization for the treatment and/or PEP (post-exposure prophylaxis) of a biothreat indication, specifically: Y. pestis, F. tularensis, and/or B. pseudomallei. Here’s the core message from the pre-solicitation notice: Topline: “The U.S. Government

6 October 2020 No Comments

Health Security underpins Economic Security: Fabulous webinar chaired by Dame Sally

Dear All, I want to call your attention to the replay available on YouTube of the excellent 24 Sep 2020 webinar entitled “The global movement of microorganisms:Tracking the spread of difficult-to-treat infections.” Chair by Dame Sally, this 90-minute webinar (link) had 4 global speakers: (Geneva) Hanan Balkhy, Assistant Director-General, World Health Organization (Addis Ababa) John Nkengasong,

2 October 2020 No Comments

PASTEUR Act (re)introduced: A delinked Pull award advances in the US!

Dear All (with thanks to Kevin Outterson for leading this note), HUGE news today: Senator Michael F. Bennet and Senator Todd Young have introduced an updated PASTEUR Act that (if enacted) would create a predictable path to rewarding new #FireExtinguishersOfMedicine for their value to society via a subscription contract (valued at $750m to $3b) that prepays

30 September 2020 No Comments

Help Alan Carr with a point survey on COVID-19 vaccines!

Dear All, Once again, we’re going to have a brief change from our usual programming with this newsletter. I hope you recognize the name Alan Carr … he is an analyst at Needham & Company (https://www.needhamco.com/) who writes regularly on the antibacterial pipeline. Go here for the most recent (14 Aug 20) newsletter on his summaries:

29 September 2020 No Comments

In Praise of Non-Inferiority

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

19 September 2020 No Comments

FDA and EMA regulatory updates / Fireside chat during the 4th AMR Conference

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

14 September 2020 No Comments

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