R&D Insight

FDA workshop: Insights on inhaled antifungals and antibacterials

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

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Developing systemic & inhaled antibiotics for lung infections

Dear All: I missed it personally, but by all reports the session on 3 June 2017 at ASM Microbe entitled “Development of New Drugs and Strategies for Hospital-Acquired Pneumonia Caused by MDR Pathogens” during ASM Microbe was an outstanding survey of this challenging area during which Shampa Das, Mike Dudley, and Sumati Nambiar gave great

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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

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FDA AdComm #2 on inhaled ciprofloxacin (11 Jan 2018); IMI Call for AMR diagnostics (28 Feb 2018 deadline)

Dear All: Two new events on the near-term horizon. First, FDA has announced an Antimicrobial Drugs Advisory Committee for 11 Jan 2018  (and materials from the meeting can now be found here). Per the FR notice, this AMDAC will cover Aradigm’s inhaled ciprofloxacin for non-CF bronchiectasis and is almost certainly a discussion of the results Aradigm’s ORBIT-3

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16 Nov FDA AdComm – Inhaled ciprofloxacin for non-CF bronchiectasis

Dear All:  A Federal Register notice has been released announcing a 16 Nov 2017 FDA Antimicrobial Drugs Advisory Committee meeting to review Bayer’s inhaled ciprofloxacin for reduction of exacerbations in adults with non-cystic fibrosis bronchiectasis with respiratory bacterial pathogens (NCFB). Post-meeting addendum: Materials from the meeting can be found here. You might also want to look at materials from

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Tetraphase sold for $14m … and $600m goes up in smoke!

Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter): Wonkish and long note alert … top-up your coffee and settle in… We learned about a week ago that Tetraphase, despite having brought an antibacterial (eravacycline) to approval, has been sold for stock worth $14.4m (plus a potential $12.5m more if aggressive sales targets are achieved).

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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

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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

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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

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Draft EMA antibacterial guidance: Analysis

Dear All: I wrote previously that EMA posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft antibacterial guidance document. I’ve now had a chance to read it in detail and thought I would share my thoughts as a way to provoke discussion. As a reminder, the

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