Renewable Fuels Agency

Iterum Therapeutics Announces Completion of Enrollment in its REASSURE Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections

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星期二, 十月 24, 2023

FDA, Food, ITRM, IV, Probenecid, Renewable Fuels Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Urinary tract infection, Clinical trial, New Drug Application, Woman, NDA, Therapy, Infection, Pharmaceutical industry, Sulopenem

DUBLIN, Ireland and CHICAGO, Oct. 24, 2023 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced the completion of patient enrollment in its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTI).

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DUBLIN, Ireland and CHICAGO, Oct. 24, 2023 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced the completion of patient enrollment in its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTI).
“We are extremely pleased to have completed enrollment in our REASSURE trial well ahead of schedule.
We now expect topline results early in the first quarter of 2024, and subject to our analysis of the data, plan to resubmit our NDA to the FDA in the second quarter of 2024,” said Corey Fishman, Chief Executive Officer.
Provided that the resubmitted NDA addresses all of the deficiencies identified in the complete response letter Iterum received from the FDA in July 2021, Iterum expects that the FDA will complete its review and take action six months from the date the FDA receives the resubmitted NDA (or during the second half of 2024).

Navistar Positioned for a More Sustainable Future in Annual Sustainability Report

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星期五, 七月 29, 2022

LISLE, Ill., July 29, 2022 /PRNewswire/ -- For more than 20 years, Navistar has released an annual sustainability report providing an overview of the company's environmental, social and governance (ESG) activities. Now, Navistar's sustainability strategy is going beyond risk mitigation into value creation to address the impact a more sustainable future would have on customers and society at large.

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Now, Navistar's sustainability strategy is going beyond risk mitigation into value creation to address the impact a more sustainable future would have on customers and society at large.
The 2021 sustainability report takes a holistic look into sustainability at Navistar including people, planet, responsibility, and impact.
The report also introduces the company's new vision to accelerate the impact of sustainable mobility and strategy which prioritizes sustainability as a strategic focus area.
Highlights from the 2021 sustainability report include:
Launched two zero-emissions products, a medium duty vehicle and a school bus.

Navistar Celebrates 40 Years of Supplier Diversity Program

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星期二, 十月 26, 2021

Since 2018, Navistar has spent over $2 billion with diverse suppliers and is the first U.S. truck original equipment manufacturer with a formal supplier diversity program.

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Since 2018, Navistar has spent over $2 billion with diverse suppliers and is the first U.S. truck original equipment manufacturer with a formal supplier diversity program.
In 2020, Navistar's Supplier Diversity leadership team, comprised of Nicole Wiggins, Corporate Diversity and Inclusion Leader; Jennifer Lee, Supplier Diversity Analyst; Raquel Salter, Supplier Diversity Program Manager; and Sharee Sheptick, Supplier Diversity Coordinator; won the "Minority Business News" All-Stars of Supplier Diversity Award.
To commemorate 40 years of the Supplier Diversity Program, Navistar hosted a virtual celebration with addresses from key leaders.
To learn more about Navistar's Supplier Diversity Program, visit the Supplier Diversity page on Navistar's website.

Advanced Biofuels USA Launches "Just A Minute (or So) about Renewable Fuels" Series of Short Educational Videos

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星期一, 二月 8, 2021

Sustainable development, Articles, Nature, Bright green environmentalism, Biofuels, Bioenergy, Sustainable technologies, Climate change mitigation, Renewable fuels, Renewable resource, Renewable energy, Renewable Fuels Agency

This new series of short videos enables you to take just a few minutes to get a quick review of essentials about renewable fuels.

Key Points:

This new series of short videos enables you to take just a few minutes to get a quick review of essentials about renewable fuels.
In addition to the YouTube videos, a page in the Advanced Biofuels USA online library includes links to additional resources and reference materials.
Here's a quick review of the current selections:
The first episode of "Just A Minute (or So) about Renewable Fuels" focuses on what might be used to make renewable fuels.
Advanced Biofuels USA, a nonprofit educational organization advocates for the adoption of sustainable, renewable fuels as an energy security, military flexibility, economic development and climate change mitigation/pollution control solution.