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Category Archives: Policy News

Denali Therapeutics Announces FDA Acceptance and Priority Review of Biologics License Application (BLA) for Tividenofusp Alfa for Hunter Syndrome (MPS II)

FDA assigns PDUFA target action date of January 5, 2026, for decision on accelerated approval.

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Webinar Recap: Immigration Compliance Under Pressure

As immigration enforcement and workplace inspections intensify under the current administration, companies in the life sciences sector, particularly those with manufacturing operations, must be proactive in strengthening compliance. Presented by Ogletree Deakin’s Kathleen Weron on July 1, 2025, this webinar provided an overview of the essential components of I-9 compliance, strategies for responding to audits, […]

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2025 BIO International Recap

BioUtah and its Utah consortium made their mark this week at the BIO International Conference, hosting a Utah Pavillion to promote the state’s fast-growing life sciences industry. The conference, held in Boston, MA. drew appproximately 20,000 attendees. The Utah delegation included BioUtah, Utah life sciences companies, the Governor’s Office of Economic Development, the Unversity of […]

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Utah Healthcare Innovation Network (UHIN) Announces Inaugural Cohort of Healthcare Startups

Utah Healthcare Innovation Network (UHIN) Announces Inaugural Cohort of Healthcare Startups

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Myriad Genetics Names Brian Donnelly as New Chief Commercial Officer

SALT LAKE CITY, April 07, 2025 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics testing and precision medicine, announced today the appointment of Brian Donnelly as chief commercial officer (CCO), effective May 1, 2025. A strategic, results-oriented leader with more than 20 years of experience in healthcare, diagnostics, and medical […]

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BioUtah Award Winners and Utah Rare Disease Advisory Council Take Center Stage at Utah Life Sciences Innovation Caucus

More than a dozen Utah legislators on Wednesday, November 20, held a breakfast meeting of the Utah Life Sciences Innovation Caucus (ULSIC) at the state capitol.

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BioUtah and Coalition of Patient Advocates Talk PBM Reform with U.S. Reps. Blake Moore and Celeste Maloy

BioUtah’s VP for Government Affairs, Denise Bell, along with a coalition of patient advocates, life sciences executives, pharmacists, physicians, oncologists, and community organizations, held a lunch meeting with Representatives Blake Moore (R-UT) and Celeste Maloy (R-UT) October 1 to discuss the dangers of giving pharmacy benefit managers (PBMs) command over how much patients pay for […]

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UTAH REPS. CURTIS AND MOORE TOUR BIOMERIEUX

Representatives John Curtis (R-UT) and Blake Moore (R-UT) toured bioMérieux.

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bioMeriéux, Curza, Present to Utah Life Sciences Innovation Caucus

Utah legislators on Wednesday, August 21, held a meeting of the Utah Life Sciences Innovation Caucus (ULSIC) at the state capitol. BioUtah President and CEO, Kelvyn Cullimore, introduced representatives from Salt Lake City-based bioMeriéux and Curza who presented before the ULSIC. Megan Kuehn, senior vice president of site operations for bioMeriéuxi, described the company’s development […]

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ARUP Statement on FDA Final Rule to Regulate Laboratory-Developed Tests as Medical Devices

ARUP maintains that the FDA’s rule will limit access to testing, stifle innovation, and increase healthcare costs.

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Ingenion Medical Obtains CE Mark for Catheter

The cymactive catheter is the first in a pipeline of urology solutions the UK-based company has planned.

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Anbex Awarded Bid from Hong Kong’s Department of Health

Anbex Awarded Bid from Hong Kong’s Department of Health

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