Author Archives: Denise Bell
Healthcare Priorities of President Biden’s FY23 Budget
On Monday, March 28, President Biden announced his budget for FY23, a $5.8 trillion proposal that reflects the administration’s funding priorities, many of which were drawn from the initial Build Back Better package. Congress is not required to adopt any or all of the president’s budget. However, each year, the president’s budget proposal serves as […]
MDUFA V Agreement Reached
The FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for MDUFA V. On March 22, FDA sent the commitment letter to Congress. Under the new agreement, the FDA would be authorized to collect at least $1.78 billion in user fees over five years. FDA could receive additional funding […]
2022 Wilson Sonsini Entrepreneur and Investor Life Sciences Summit is a Raging Success
The 2022 Wilson Sonsini Entrepreneur and Investor Life Sciences Summit presented by BioUtah, BioHive and the PIVOT Center attracted a record setting 300+ registrants along with an impressive line-up of distinguished speakers, national and local investors and numerous Utah life sciences startups. Now in its 7th year, the Summit (our first in person since COVID-19) […]
Reps. Stewart and Curtis Health Staff Tour Life Sciences Companies
Over the last couple of weeks, health legislative staff for Utah Reps. Chris Stewart (R-UT) and John Curtis (R-UT) have been touring a number of the state’s life sciences companies to learn more about their innovative work and our growing BioHive. Colleen Malloy White, on behalf of Curtis, visited IONIQ Sciences, ARUP Laboratories and ATL […]
Transition Plan for Medical Devices Issued FDA EUAs
To help fight the pandemic, the FDA has been issuing EUAs and exercising enforcement discretion for medical devices needed to diagnose, treat, or prevent COVID-19. Last month, the agency issued two draft guidances related to transition plans to regular compliance for COVID-19 related medical devices that fall under EUAs or Agency Enforcement Policies that have […]
Salt Lake Tribune Features IONIQ Sciences Breast Cancer Screening Technology
In a sign that our BioHive is truly buzzing, the Salt Lake Tribune, recently ran an article on advances in breast cancer detection, highlighting the innovative breast cancer screening technology being developed by IONIQ Sciences. The article notes that IONIQ has teamed up with IONIQ scientific advisor and University of Utah assistant professor, Dr. Benjamin […]
Senate Health Panel Questions FDA Nominee Dr. Robert Califf
On Tuesday, December 14, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on the nomination of Dr. Robert Califf to be FDA Commissioner. In his testimony, Califf, who briefly led the FDA during President’s Obama’s second term, said his first priority as FDA Commissioner would be the pandemic response and applying […]
Pfizer to Acquire Arena Pharmaceuticals
Pfizer and Arena Pharmaceutical on Dec. 13 announced that the companies have entered into an agreement under which Pfizer will acquire Arena, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases. Under the terms of the agreement, Pfizer will acquire all the outstanding shares of Arena for $100 per […]
Courts Halt Two Biden Vaccine Mandates
In two separate rulings on Tuesday, federal judges temporarily halted the Biden Administration’s COVID-19 vaccine mandates for healthcare workers and federal contractors. One ruling, in a Missouri federal district court, prohibits CMS from enforcing its COVID-19 vaccine mandate in Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming. A second […]
Recap of the Virtual 2021 BioHive Renalytix Summit
BioUtah and BioHive on Nov. 12 presented with great fanfare the Renalytix BioHive Summit – the 12th annual gathering of Utah’s life sciences community – but this year with a new name. Convening under the BioHive banner is part of a larger effort to brand, build and bring together Utah’s fast-growing life sciences hub. We […]
Introduction of Bipartisan CURES 2.0 Bill
Reps. Diana DeGette (D-Colo.) and Fred Upton (R-Mich.) on Tuesday, November 16, introduced the CURES 2.0 bill, a sequel to the initial 21st Century Cures Act that passed Congress in 2015. According to a statement released by DeGette, while the first CURES bill sought to improve how new drugs and treatments are researched and developed in […]
SDP Oncology Announces First Patient Dosed in Phase 1 Dose Expansion Study of TP-1287 in Patients with Sarcoma
Sumitomo Dainippon Pharma Oncology (SDP Oncology), which has research facilities in Lehi, Utah, recently announced that the first patient has been dosed in the Phase 1 dose expansion portion of the study evaluating the investigational agent TP-1287, an oral cyclin-dependent kinase 9 (CDK9) inhibitor, in patients with sarcoma. “Patients with sarcoma currently face a significant […]
