Category Archives: Policy News
BraveHeart Wireless Partners with iKure and IBM
The three companies have partnered together to bring wearable BraveHeart patches to at-risk patient’s in India’s remote “last mile.” Read the full article from CNN here.
New Embolic Device Used in Interventional Oncology for Highly Targeted Tumor Treatment
Novel Interventional Oncology Embolization Device Successfully Used in Trans-Radial Access Procedures for Tumor Devascularization November 24, 2020 – Fluidx Medical Technology reported successful patient use of the GPX Embolic Device to therapeutically devascularize, or block blood supply to, a tumor. “We are impressed with the GPX embolic,” said Andrew Holden, M.D., MBChB, FRANZCR, EBIR, ONZM, […]
Governor Herbert Updates State of Emergency, New Public Health Order Issued, Revisions to Employee Quarantine
Governor Herbert’s previous State of Emergency ended at midnight Monday, November 23 and a new public health order has been issued. The new health order took effect November 24 and will remain in effect until December 8, unless otherwise modified or amended. The COVID-19 Transmission Index remains in place. All but three counties (Rich, Daggett, […]
Most Favored Nation Rule Poses Patient Access Issues, Faces Legal Challenges
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 […]
Milken Institute Ranks Utah Sixth in Nation for Innovation Capacity
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 […]
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 […]
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 […]
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,” […]
Sanofi Commits $1M to Support Parkinson’s Disease Genetic Research
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 […]
SBA Extends PPP Loan Deferral, New Streamlined Forgiveness for Loans of $50,000 or Less
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 […]
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 […]
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 […]
