R&D Insight

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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Where’s the innovation? / Indian Priority Pathogen List / DTR video explainer

Dear All, Three things briefly this evening: First, the observation about the limited degree of innovation across products in Phases 1-3 in the recent newsletter about the Pew Pipeline review (only 1 in 4 are novel classes or novel mechanisms; none are potentially active against Gram-negative ESKAPE pathogens or WHO critical threat pathogens) generated queries along

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AMR Action Fund ($1b for P2-3): Video chat with new CEO! New committed funds!

Dear All, I’ve written before about the AMR Action Fund (9 Jul 2020 newsletter): In brief, it is ~$1b pledged by over 20 leading pharmaceutical companies to support the Phase 2-3 studies needed to bring 2-4 new antibiotics to approval by 2030 Stated differently, the AMR Action Fund provides Push incentives for Phase 2-3 to complement the Push Incentives

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JPIAMR call: 25m Euro for interventions to reduce/prevent AMR

Dear All, JPIAMR is today launching an international call entitled “One Health interventions to prevent or reduce the development and transmission of AMR.” The call, with financial support from the European Commission, includes 30 funding organisations from 21 JPIAMR member countries and has a total estimated call budget of 24.9 million Euro. Here’s the description of

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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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Melinta goes bankrupt / Never let a good crisis go to waste

Dear All (long-ish, wonk-ish note alert … lots of details to absorb): This newsletter has a followup here. Sadly, Melinta Therapeutics, Inc. declared bankruptcy just before the end of 2019 (link). Formerly known as Rib-X (link), Melinta went public in 2017 through a reverse merger with Cempra (link); and via a series of deals had four

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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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Language matters: CRE vs. CPE; SDD vs. I; and MDR, XDR, PDR, UDR vs. DTR

Note: See also these related newsletters: 13 Jan 2019 (link) on DTR as part of the language of resistance and 7 June 2020 (link) on using DTR to estimate antibiotic value. Dear All (wonk-ish note alert!), Three technical points for your consideration today. All focus on the subtleties of language, something I always find fascinating

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MTEC: A funding source for anti-infective projects that (also) have military uses

Dear All, I have recently become aware of MTEC (Medical Technology Enterprise Consortium), a 501(c)(3) nonprofit organization designed to accelerate the translation of medical technologies into solutions that prevent and treat injuries and restore the health of United States military personnel.  MTEC is a public-private collaboration between the U.S. federal government and the businesses and

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