Pfizer, BioNTech Get FDA Fast Track Status for COVID-19 Vaccines

U.S. Pfizer and Germany’s BioNTech announced Monday that they have received Fast Track designation from the FDA for two COVID-19 vaccine candidates – BNT162b1 and BNT162b2 – part of the companies’ “Project Lightspeed” program. The designation was issued based on promising preliminary data from Phase 1/2 clinical studies. The FDA’s Fast Track designation is intended […]

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Governor Herbert Releases Utah Leads Together Plan Volume IV; Economic Response Task Force Report “Utah Rising” Includes Life Sciences

On June 16, Governor Herbert released Volume IV of the Utah Leads Together plan, which presents Utah’s economic recovery and revitalization plan, using a 100, 250, and 500-day time horizon. Volumes I, II, and III of the Utah Leads Together plan presented economic phases, color-coded health guidance, instructions for high-risk individuals, recommendations from Utah’s multi-cultural […]

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Senate Finance Committee Hearing Raises Issue of U.S. Reliance on Foreign Drug Supplies, Civica Testifies

The Senate Finance Committee held a hearing this week on the FDA’s oversight of foreign drug manufacturers, which also highlighted increased concerns about the U.S.’s dependence on foreign-made medicines. The committee heard testimony from FDA officials and generic drug manufacturers, including Salt Lake-based Civica. Founded in 2018, Civica, a non-profit social welfare organization, is committed to […]

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Changes to PPP Rules Set After Senate Passes Paycheck Protection Flexibility Act of 2020

By Brandon Allfrey, Partner, Squire, Brandona@squire.com Late Wednesday evening, the U.S Senate passed by unanimous consent the Paycheck Protection Program Flexibility Act of 2020 to ease some of the original rules of the PPP application and forgiveness rules from the CARES Act and the subsequent guidance from the Treasury Department.  The details of the Act did not change from the […]

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Governor Issues Executive Order Releasing Updated Guidelines for Low-Risk Phase in the Utah Leads Together Plan

SALT LAKE CITY (May 27, 2020) – Gov. Gary R. Herbert has issued an Executive Order updating guidelines for areas in low health risk designation under Utah’s phased health guidance plan. The order specifically addresses updated guidelines pertaining to social gatherings, education, businesses, travel and events. “We are making progress and we can see that […]

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House to Act on PPP Changes Next Week

The U.S. House of Representatives is expected to vote next week on bipartisan legislation, the Paycheck Protection Flexibility Act, which would revamp the popular Paycheck Protection Program (PPP) to allow for more flexible terms. In Utah, for rounds one and two of funding, a total of 47,046 businesses have received PPP loans, amounting to nearly […]

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President Trump Issues Executive Orders for U.S. Manufacturing of Strategic Medical Supplies; Regulatory Relief

On May 14, President Trump signed an executive order to encourage the domestic production of  critical medical supplies. In the current pandemic, U.S. reliance on China for products such as personal protective equipment, ventilators, and antibiotics, has drawn increased interest in having critical drugs and medical devices manufactured in the homeland. The order would give […]

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LabCorp Expands Access to At-Home COVID-19 Collection Test Kits; Lab Association Pushes for Federal Funding

On May 12, LabCorp announced that its COVID-19 at-home collection test kit is now available to individuals who have symptoms for COVID-19 as well as individuals without symptoms who may have been exposed to the virus. The diagnostic test, which uses a swab, is available through the company’s Pixel by LabCorp™ online platform.  Last month, […]

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