On June 13, the U.S. Food and Drug Administration (FDA) issued the final guidance: Content of Premarket Submissions for Device Software Functions. The final guidance provides information regarding the recommended documentation sponsors should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. The guidance replaces the FDA’s […]
The BioHive community was featured prominently at the One Utah Summit held on May 10 at the Grand America Hotel in Salt Lake City. Speakers from the life sciences industry addressed the crowd on topics ranging from job creation and talent development to life-saving innovation and drug discovery. Tom Polen, CEO of BD, and Rob […]
Recursion Co-founder and CEO, Chris Gibson, Ph.D., was honored at the One Utah Summit on May 10, receiving the Governor’s Medal for Science and Technology. Gov. Spencer Cox presented the award during the summit’s special recognition ceremony. The prestigious award commends the distinguished service, significant achievement, and positive economic impact of individuals to the state […]
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 […]
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 (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 […]
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 […]
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 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 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 […]
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. […]
U.S. Senator Mike Lee (R-UT) on July 16 toured Stryker’s Neurovascular Division with division President, Mark Paul, joined by BioUtah President and CEO, Kelvyn Cullimore and members of the Senator’s staff. During the tour, Lee learned about the innovative, best-in-class technologies manufactured at the Salt Lake City facility to treat stroke patients. Stroke is the […]