R&D Insight Archives • Page 32 of 35 • AMR.Solutions

6 Jun 2019 FDA AMDAC: Discussion of Pretomanid’s NDA for MDR-XDR TB

Dear All: FDA today posted a Federal Register announcement of an Antimicrobial Drugs Advisory Committee (AMDAC) meeting on 6 June 2019. The AMDAC will discuss pretomanid (formerly, PA-824) tablets for oral administration, “proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment-intolerant or non-responsive

24 April 2019 No Comments

FDA workshop on development of therapies for non-tuberculous mycobacterial (NTM) disease

Dear All: FDA held a workshop (go here for workshop agenda and materials) on 8 Apr 2019 on “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease.” I attended by webcast and worked with an on-the-spot attendee (David Melnick of Spero Therapeutics) to develop this summary. The workshop started with a review of the underlying

12 April 2019 No Comments

12 July 2019 FDA public meeting for comments on the 2018 LPAD guidance

Dear All: Apologies for the back-to-back emails, but this one just came across the transom. In brief, FDA will hold a public meeting on Friday 12 Jul 2019 (9a-3p EDT, FDA White Oak Campus) at which FDA is soliciting public comment on the 2018 LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs) guidance. You can register

1 April 2019 No Comments

DHHS Secretary Alex Azar, CDC, and Dame Sally Davies: An event to celebrate AMR fighters around the globe

Dear All, If you’re going to be in New York City on 23 Sep for the UN General Assembly, you are invited to join U.S. Health and Human Services Secretary, Alex Azar, experts from the U.S. Centers for Disease Control and Prevention, and hundreds of organizational and global leaders at an evening celebrating global AMR

16 September 2019 No Comments

India bans food ag use of colistin / CDC updates report on US use of antibiotics

Dear All, Two mid-week notes: First (and huge!), India’s Ministry of Health issued a notification last week prohibiting the “manufacture, sale and distribution of the drug colistin and its formulations for food-producing animals, poultry, aqua farming and animal feed supplements” because such use is “likely to involve risk to human beings.” You can find this on multiple

22 August 2019 No Comments

Meetings galore! AMR Awareness (Geneva), EMA information day for SMEs, One Health, CNS infections, and clinical trial methodology

Dear All: There are days when I have the feeling of drinking from a fire hose … and this is one of them! Multiple interesting new events have crossed my radar in the past 48 hours with topics that span AMR Awareness (two events in Geneva next week!), CNS infections (Rockville, MD), an EMA info-day

18 May 2018 No Comments

33,100 deaths in EU/EEA during 2015 attributable to resistant bacteria

Dear All: Cassini et al. have just published a truly scary paper. Here’s the bulk of the abstract … I can’t improve on it. Methods: We estimated the incidence of infections with 16 antibiotic resistance–bacterium combinations from European Antimicrobial Resistance Surveillance Network (EARS-Net) 2015 data that was country-corrected for population coverage. We multiplied the number of bloodstream

6 November 2018 No Comments

New IMI Accelerator Program For AMR-Focused Product Development

Dear All: EU’s IMI (Innovative Medicine Initiative) has initiated a new accelerator program for AMR-focused products! I added the links in the last newsletter … now it’s time for the details. (And separately please also note that there are 6 new meetings in the future meetings list … look closely … it is impossible to keep up!) This new

15 August 2018 No Comments

Save the date: 18-19 Nov 2019 FDA-IDSA-NIAID-Pew-sponsored workshop: “How can we improve antibacterial development?”

Dear All, Please mark your calendar now to be in the Washington, DC area on 18-19 Nov 2019 for a 2-day workshop at FDA’s White Oak Campus focused on enhancing the clinical trial enterprise for antibacterial drug development. Jointly co-sponsored by FDA, IDSA, NIAID, and Pew Trusts, this meeting will have a particular focus on (a)

4 October 2019 No Comments

IDSA’s 10×20 could be 20×20 and yet not enough! / Harvard course on FDA and prescription drugs

Dear All: Two things on a Friday: First, I just learned of IDSA’s release of its latest paper (link) in the Bad Bugs/No Drugs and 10×20 series. Officially entitled “The Infectious Diseases Society of America’s 10 × ’20 Initiative (Ten New Systemic Antibacterial Agents FDA-approved by 2020): Is 20 × ’20 a Possibility?”, I think a

22 March 2019 No Comments

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