FDA Posts Serology Templates for Test Developers

The FDA on Nov. 24 posted two templates with recommendations on what to include in EUA requests for serology tests. These templates provide the FDA’s current recommendations on what data and information should be submitted to the FDA in support of an EUA request or Pre-EUA submission for a SARS-CoV-2 antibody test or home specimen […]

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University of Utah to Speed Process of Bringing New Therapeutics to Patients

University of Utah Partners for Innovation, Ventures, Outreach & Technology (PIVOT) Center: Nov 18, 2020 10:00 AM The university’s Huntsman Cancer Institute (HCI), College of Pharmacy, and the Partners for Innovation, Ventures, Outreach & Technology (PIVOT) Center have partnered to establish the University of Utah Therapeutics Accelerator Hub (U2TAH, or the Accelerator). Photo credit: University […]

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U named Innovation and Economic Prosperity University

Article Courtesy of @theU The Association of Public and Land-grant Universities (APLU) awarded the University of Utah the Innovation and Economic Prosperity designation, which recognizes universities that promote growth, innovation and economic development in their regions. “This is tremendous recognition of the important role the University of Utah plays as an economic engine for our state,” […]

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Pediatric Rare Disease Voucher Program Extended

Congress recently provided a short-term extension until December 11 of the Rare Pediatric Disease Priority Review Voucher program. The program was set to expire on September 30, but was given a reprieve in the Continuing Appropriations Act, 2021 and Other Extensions Act (H.R. 8337) that kept the government funded. Congress will have to act again […]

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Trump Administration Issues Final Drug Importation Rule

On September 24, the Trump Administration released a final rule to allow the importation of prescription drugs from Canada. The final rule follows a notice of proposed rule making last December, in which HHS outlined two potential pathways for importation. The first called the Section 804 Importation Program, is established under the final rule, while […]

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President Trump Signs Executive Order on Healthcare, Pre-existing Conditions

During a campaign event yesterday in Charlotte, North Carolina, President Trump signed an executive order on a range of health issues, including protecting people with pre-existing medical conditions, lowering prescription drug costs, increasing consumer choice, and providing greater transparency. The order also directs HHS Secretary Alex Azar to work with Congress to pass legislation to […]

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Utah COVID-19 Grant Programs Update

BioUtah is pleased to provide the life sciences community with a current summary of state COVID-19 initiatives and grant programs managed by the Governor’s Office of Economic Development. Visit business.utah.gov/coronavirus to learn more. Coronavirus Prevention Messaging Grants Grants of up to $50,000, $75,000 or $250,000 for social media, targeted audience and mass media campaigns, respectively, […]

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Trump Administration Releases COVID-19 Vaccine Distribution Strategy

The Administration on Wednesday released a detailed plan for the distribution of free COVID-19 vaccines beginning next year. The plan would prioritze vaccines for healthcare workers, essential employees, and high-risk indiividuals. From there, distribution would be expanded to the broader population. The plan includes two documents: documents: A strategic distribution overview along with an interim […]

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