R&D Insight

Excellent Coronavirus Vaccine Q&A with Tony Fauci from JAMA Network

Dear All, Howard Bauchner, the editor-in-chief of JAMA, regularly does 30-minute Q&A podcasts. Today’s Q&A was with Tony Fauci and is a superb review of current state of play. Yes, he is ready to get the vaccine and is going to be vaccinated in public! Go here to listen. For more, below my signature you

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EMA Network Strategy to 2025: Action on AMR / Comments due 4 Sep

Dear All, We learned today during the BEAM AMR conference (link) that EMA released a call on 7 June 202 for comments on their draft Network Strategy to 2025 that considers how “the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges

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WHO 2020 preclinical antibacterial pipeline data call

Dear All:  As you will hopefully recall from November 2019, Theuretzbacher et al. published a review of the preclinical pipeline that summarized data on 407 companies active in the preclinical R&D space during the window Sep 2016 through 1 May 2019. Go here for the newsletter about that paper and go here for my master summary

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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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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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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:

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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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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

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