Author Archives: Denise Bell
PhotoPharmics Stay-At-Home Trial for People with Parkinson’s
This week, PhotoPharmics announced a collaboration with the Center for Health + Technology (CHeT) at the University of Rochester Medical Center to conduct an at home, telemedicine, phase 3 trial for the company’s Celeste® – a non-invasive, specialized light therapy device for Parkinson’s. The trial follows an FDA Breakthrough Device Designation for the device in […]
Johnson & Johnson to Begin COVID-19 Vaccine Clinical Trials in Humans Next Week
Last month, Johnson & Johnson (J&J) announced that its Phase 1/2a in-human clinical trial of its potential COVID-19 vaccine was expected to begin in July – instead of September as initially scheduled. On Thursday, as reported by Fierce Pharma, J&J chief scientific officer Paul Stoffels confirmed the accelerated timeline, saying that the company has seen […]
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 […]
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 […]
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 […]
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 […]
ProLung Has a New Name, Gets $3.3 Million Private Placement and More…
ProLung, now IONIQ Sciences (IONIQ), has been on a roll! Last week, the company announced that they had fully subscribed a $3.3 million private placement. This week, the company unveiled its new name and also announced the initiation of an institutional private equity offering. The new corporate name – IONIQ Sciences – reflects the company’s mission […]
House Passes Bill to Fix PPP, Provide Flexibility For Small Businesses
The House on Thursday passed legislation to make it easier for small businesses to have their PPP loans forgiven, including extending the timeframe during which businesses must use funds and easing requirements on how the funds can be used. The Paycheck Protection Program (PPP) Flexibility Act, authored by Rep. Dean Phillips (D-Minn.) and Rep. Chip […]
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 […]
Grants Still Available for the Utah Commercial Real Estate Assistance Program
On May 11, 2020, the Governor’s Office of Economic Development (GOED) began accepting applications for the Utah Commercial Real Estate Assistance Program, to provide rental relief to small businesses that have lost revenue as a result of COVID-19 mitigation efforts. The program, with $40 million in funds, has received 2,700 applications to date, totaling just […]
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 […]
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 […]
