Author Archives: Denise Bell
U.S. Department of Labor’s Occupational Safety and Health Administration Unveils Rule to Mandate COVID-19 Vaccines for Large Employers
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, […]
Sumitomo Dainippon Pharma Oncology Announces First Patient Dosed in Phase 1 Study of DSP-0390 in Patients with Recurrent High-Grade Glioma
Sumitomo Dainippon Pharma Oncology (SDP Oncology), which has research facilities in Lehi, Utah, recently announced that the first patient has been dosed in a Phase 1 study evaluating its investigational agent DSP-0390, an emopamil-binding protein (EBP) inhibitor, for the treatment of patients with recurrent high-grade glioma. “Dosing the first patient in this study represents another […]
White House Unveils Build Back Better Framework
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 […]
CMS Proposes Repeal of Medicare Coverage of Innovative Technology Pathway
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 – […]
Moderate Democrats Threaten “Build Back Better” Drug Price Controls
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,” […]
US Ski, Snowboard Team Uses R-Zero Disinfectant System
Last month, BioUtah News and Events reported that the U.S. Ski and Snowboard Team would be using R-Zero’s hospital-grade, whole-room ultraviolet light disinfection system called Arc to mitigate against COVID-19 and other pathogens in their training rooms.
House Passes $3.5 Trillion Budget, Push Medicare Drug Price Negotiations
On Tuesday, the House Democrats passed a budget blueprint on a party line vote. That blueprint allows Committees in the House to start writing the administration’s $3.5 trillion social spending or “care infrastructure” legislation. Democrats hope to move the spending measure as a reconciliation measure in the Fall. Under the reconciliation process, only 51 votes […]
Representative Moore Tours Utah Companies – BD, Edwards Lifesciences and Stryker
BioHive on Wednesday was front and center as U.S. Representative Blake Moore (R-UT-1) toured Edwards Lifesciences, BD and Stryker – all leading medical device manufacturers in Utah that provide thousands of good-paying, stable jobs. During the visits, Moore was able to see first-hand the work that these companies do to innovate and produce life-changing technologies. “We […]
SkinTE® Met Primary and Secondary Endpoints in Final Analysis from Diabetic Foot Ulcer Trial
PolarityTE on July 28 announced final data from a multi-center randomized controlled trial evaluating treatment of Diabetic Foot Ulcers (DFU) with its investigational product SkinTE®. The trial met the primary endpoint of wound closure at 12 weeks and secondary endpoint of Percent Area Reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks. Nikolai […]
PolarityTE Receives Notice of Allowance for Chinese Patent
PolarityTE recently announced that the China National Intellectual Property Administration (CNIPA) issued a Notification of Allowance for Chinese Patent Application No. 201580075326.3. The allowed claims relate to skin-regenerative compositions utilizing PolarityTE’s minimally polarized functional unit (MPFU) technology as well as methods of making a skin-regenerative composition utilizing the MPFU technology. This most recent allowance further […]
PolarityTE Submits Investigational New Drug Application for SkinTE®
PolarityTE on Monday announced the submission of an investigational new drug application (IND) to the FDA seeking authorization to commence a clinical trial to evaluate its SkinTE product for the proposed indication of treatment of chronic cutaneous ulcers. SkinTE is PolarityTE’s human cellular and tissue-based product derived from a patient’s own skin. David Seaburg, Chief Executive […]
Foldax Presents at the 2021 Transcatheter Valve Technologies Meeting
Last week, Foldax presented on the company’s innovative Tria valve at the 2021 Transcatheter Valve Technologies (TVT) meeting. View the slides HERE. The presentation titled “Foldax Biopolymer Valves: An Alternative to Tissue Based Leaflet Valves” was given by Foldax investigator, Dr. David Heimansohn, chief of surgery at St. Vincent/Ascension in Indiana and was well received. […]
