Policy News
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Invest Lithuania
BioUtah has established a partnership with Invest Lithuania, an arm of the Lithuanian government focused on developing life…
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E&C Leaders Unveil FDA User Fees Legislative Package
Bipartisan Agreement Will Support Innovation, Lower Costs, and Improve People’s Lives Washington, D.C. – Energy and Commerce Committee Chairman…
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CURTIS, CRAIG INTRODUCE BILL TO IMPROVE ACCESS TO GENERIC TREATMENTS
CURTIS, CRAIG INTRODUCE BILL TO IMPROVE ACCESS TO GENERIC TREATMENTS
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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…
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FACT SHEET: The Biden Administration’s Historic Investment in Pandemic Preparedness and Biodefense in the FY 2023 President’s Budget
The Biden Administration’s Investment in Pandemic Preparedness and Biodefense in the FY 2023 President’s Budget
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MDUFA V Agreement Reached
The FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for MDUFA…
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Senate HELP Committee Advances PREVENTS Pandemic Act
The Senate HELP Committee on Tuesday voted 20-2 to advance legislation, the PREVENTS Pandemic Act.
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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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…
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BioUtah Submits Comments on Proposed MCIT Repeal
VIA ELECTRONIC SUBMISSION October 15, 2021 The Honorable Chiquita Brooks-LaSure Administrator Centers for Medicare & Medicaid Services Department…
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BioHive Names Katelin Roberts Executive Director
BioHive, Utah’s collective of life sciences and healthcare innovation companies, today announced that Katelin Roberts will serve as…
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Sera Prognostics Adds New Senior Executive
Sera Prognostics Inc., The Pregnancy Company™ (NASDAQ: SERA) will add a new doc to the team. Dr. Michael…
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ARUP Wins Two of Six Prestigious Choosing Wisely Champion Awards
SALT LAKE CITY (September 21, 2021)—Andrew Fletcher, MD, medical director of Consultative Services at ARUP Laboratories, and ARUP’s…
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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…
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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…
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Co-Diagnostics JV CoSara Receives Clearance from Indian FDA for Chikungunya and Dengue Tests
The Saragene test kits approved by the CDSCO use the Company’s patented CoPrimer™ technology for the qualitative detection…
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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…
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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…
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COVID-19 Vaccine Policies Should Reflect the Best Available Scientific Evidence in Order to Improve Vaccine Access & Uptake
The Biotechnology Innovation Organization (BIO) believes that legislation and public health policies to address this pandemic and the…
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Health-Tech Company Nusano To Open an Office in Utah
Nusano, a health-tech company aiming to revolutionize uranium-free radioisotope development and production in various diagnostic and therapeutic medical…
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Phoenix PharmaLabs Raises More than $1 Million for Continued Development of Non-Addictive Opioids
Phoenix PharmaLabs, Inc. has completed a second successful round of financing raising $1.07 million via the Netcapital equity…
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Biden Administration Recommends Policy Changes to Secure U.S. Pharmaceutical Supply Chain
In last week’s BioUtah News and Events, we highlighted the Biden Administration’s formation of a task force to…
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Elute Receives FDA Authorization For Its First Clinical Trial Using Antibiotic Eluting Bone Void Filler
Elute has received an Investigational Device Exemption (IDE) authorization from the FDA to use its EP Granules with…
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Senate Passes Endless Frontiers Act to Boost U.S. Innovation
On Tuesday, the U.S. Senate passed the Endless Frontier Act to boost U.S. innovation and out-compete China. The…
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House Democrats Urge HHS Secretary to Restore FDA Authority of COVID-19 Lab Developed Tests
Last August.under the Trump Administration, HHS announced that FDA would not have premarket review authority and oversight over…
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Letter to Utah Congressional Delegation RE: H.R. 3, The Lower Drug Costs Now Act
Today, BioUtah, in conjunction with Centro Civico Mexicano, First Step House, International Cancer Advocacy Network, Mental Healthy FIT,…
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CMS Again Delays Program to Expedite Coverage of Innovative Technologies
The Centers for Medicare & Medicaid Services (CMS) has once again delayed the January 14, 2021 final rule…
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Who Develops Medicines? A New Study Highlights Role of Private Investment
Discussion around drug pricing often raises the issue of just how much NIH funding drives the development of…
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House Energy and Commerce Committee Holds Hearing on Drug Price Controls
The House Energy and Commerce Health Subcommittee on Tuesday held a hearing on “Negotiating A Better Deal: Legislation…
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Biden Supports IP Waiver for COVID-19 Vaccines
The Biden administration has announced that they will back a waiver of the WTO Trade-Related Aspects of Intellectual…
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Biden’s First Address to Congress Calls for Giving Medicare Power to Negotiate Drug Prices
President Joe Biden’s first major joint address to Congress on Wednesday included calls to give Medicare the power to…
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BioUtah Statement on House Democrat Leaders Drug Pricing Legislation
Salt Lake City, Utah (April 22, 2021) – BioUtah President and CEO, Kelvyn Cullimore, issued the following statement…
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Life Sciences Company Valuation Webinar by Scalar & Now CFO
In case you missed the recent NOWCFO/Scalar webinar “What is Your Life Science or Bio Tech Company’s Worth?”,…
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