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 […]
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 […]
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 […]
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 […]
The Department of Labor’s Occupational Safety and Health Administration (OSHA) yesterday issued a rule requiring employers with 100 or more employees to enforce a mandatory COVID-19 vaccination policy, unless they adopt a policy requiring employees to choose to either be vaccinated or undergo regular COVID-19 testing and wear a face covering at work. The rule, […]
After going to Capitol Hill yesterday to try to rally support from House Democrats, President Biden announced a framework for a $1.75 T “Build Back Better” social spending plan. The framework, which comes after months of negotiations with party moderates and progressives who have not seen eye-to-eye on policies and pay-fors, is still subject to […]
VIA ELECTRONIC SUBMISSION October 15, 2021 The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Attention: CMS-3372-P2 P.O. Box 8013 Baltimore, MD 21244–8013 Re: Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Proposed Rule: [CMS-3372-P2] Dear Administrator Brooks-LaSure: BioUtah appreciates the […]
BioHive, Utah’s collective of life sciences and healthcare innovation companies, today announced that Katelin Roberts will serve as the full time Executive Director, effective immediately. Roberts has been serving as interim Executive Director since the launch of BioHive last year. BioHive’s mission is to brand, build and bring together Utah’s robust and growing life sciences […]
Sera Prognostics Inc., The Pregnancy Company™ (NASDAQ: SERA) will add a new doc to the team. Dr. Michael R. Foley has been appointed to the position of Chief Medical Officer starting in January 2022. Salt Lake City-based Sera Prognostics focuses on neonatal health as well as maternal health using biomarker information. Using PreTRM® test reports, […]
SALT LAKE CITY (September 21, 2021)—Andrew Fletcher, MD, medical director of Consultative Services at ARUP Laboratories, and ARUP’s Consultative Services team, led by Sandy Richman, are among six healthcare leaders and systems honored with 2021 Choosing Wisely Champion Awards from the American Society for Clinical Pathology (ASCP). Launched in 2016, the Choosing Wisely Champions Program […]
CMS Proposes MCIT Repeal On September 13, CMS issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) pathway initally finalized in a January 14, 2021 rule. The MCIT pathway would have provided four years of immediate Medicare coverage for FDA-designated breakthrough medical devices and diagnostics that have been market authorized – […]
Congressional committees this week got down to business writing the details of the Biden Administration’s $3.5 trillion “Build Back Better” reconciliation bill. Of particular interest to the life sciences industry was consideration of drug price control provisions in the House Energy and Commerce and Ways and Means Committees. In its version of “Build Back Better,” […]