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Category Archives: Policy News

Most Favored Nation Rule Poses Patient Access Issues, Faces Legal Challenges

By Denise Bell | Published November 24, 2020

As reported in last week’s BioUtah News and Events, HHS on Nov. 20 released an interim final rule (IFR) implementing the Most Favored Nation (MFN) Model, a new payment model through the Center for Medicare and Medicaid Innovation (CMMI) that would, starting January 1, base the price Medicare pays for for 50 high-cost Medicare Part […]

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Milken Institute Ranks Utah Sixth in Nation for Innovation Capacity

By Denise Bell | Published November 24, 2020

The Milken Institute 2020 State Technology and Science Index ranks Utah #6 in the nation for its knowledge economy and capacity for innovation – same ranking as last year. The index, published annually, compares each state’s capacity for achieving prosperity through scientific discovery and technological innovation, by analyzing their performance on a number of key […]

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FDA Posts Serology Templates for Test Developers

By Denise Bell | Published November 24, 2020

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

By admin | Published November 20, 2020

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

By admin | Published November 13, 2020

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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Sanofi Commits $1M to Support Parkinson’s Disease Genetic Research

By Denise Bell | Published October 23, 2020

Sanofi and the Parkinson’s Foundation announced on Wednesday a new research collaboration to advance the availability of genetic testing and counseling for people with Parkinson’s disease in the U.S. Over the next two years, Sanofi will provide $1 million in research funding to support the PD GENEration Mapping the Future of Parkinson’s Disease initiative. The […]

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SBA Extends PPP Loan Deferral, New Streamlined Forgiveness for Loans of $50,000 or Less

By Denise Bell | Published October 16, 2020

On October 7, the SBA released updated FAQs (question #52) to clarify that lenders must recognize the extended deferral period for payments on the principal, interest, and fees on all PPP loans, even if the initial loan terms indicates a six-month deferral (the initial period when the program was first enacted). Under the Paycheck Protection […]

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Pediatric Rare Disease Voucher Program Extended

By Denise Bell | Published October 9, 2020

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

By Denise Bell | Published October 2, 2020

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

By Denise Bell | Published September 25, 2020

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

By Denise Bell | Published September 18, 2020

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

By Denise Bell | Published September 18, 2020

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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