R&D Insight

Treating resistant Gram-negatives: IDSA provides pragmatic expert advice

Dear All, IDSA (Infectious Diseases Society of America) have today released an eagerly awaited new guidance document on treating infections due to resistant Gram-negative bacteria (link). 8 Apr 2021 update: IDSA have published an updated version of this document. It excellent to see IDSA working steadily to provide up-to-the-minute advice! The thing that makes this

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COVID-19 and bacterial infections / New webinars and meeting updates

Dear All: Three brief items for you today.  First up: Perhaps like many of you, I’ve been wondering whether or not COVID-19 and bacterial resistance would begin to cross paths in some fashion. I can’t think of a reason why COVID-19 would directly cause resistance, but use of antibiotics becomes pretty common after you’ve been

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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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Pull incentives in the EU / Statements by Commissioner Kyriakides

Dear All, Stella Kyriakides, the European Commissioner for Health and Food Safety, made some really interesting statements before the European Parliament’s health committee (ENVI) on Thursday of last week (22 April). Per this Exchange of Views on the EP’s multimedia center and this news report, here are some highlights: In the Exchange of Views at 00:03:44, she said: “Later

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Updated global antibacterial pipeline review from Pew Trusts

Dear All, Pew Charitable Trusts have released an excellent update to their long-running series of pipeline reviews. Here are the links you need: (link) Pipeline of traditional products (classical small molecules) (link) Pipeline of non-traditional products (vaccines, immunotherapies, and other out-of-the-box ideas) (link) An infographic that you can use for sharing the key points (link)

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Funding, Filing, and Finance: Most current update of this lecture

Dear All: I had the opportunity today to share an updated version of my “Funding, Filing, and Finance” talk with the attendees of Superbugs & Superdrugs in London. Topics covered were: Funding: What are the global initiatives? Where can you find information on how you could apply? Filing: What are the must-read background documents for developers? What

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FDA workshop: Clinical trial designs for agents for non-tuberculous mycobacterial infection on 8 Apr 2019

 REDear All: I just heard to today that FDA is holding a public workshop entitled “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease” on 8 April 2019 from 8.30a-5.00p. Register here. Per their website, “the purpose of the public workshop is to discuss the clinical trial design considerations, including endpoints, related to the

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