Recent BioUtah News & Events

POLICY UPDATE – DRUG PRICING Concerns Expressed by Investors, Small Companies  House Speaker Nancy Pelosi’s drug pricing measure, H.R. 3 , the Elijah E. Cummings Lower Drug Prices Now Act, is coming under increasing scrutiny as concerns grow about the bill’s negative impact on innovation and future investment in smaller, emerging drug discovery companies. Yesterday, […]

Speaker Pelosi’s drug bill, H.R. 3, now named the Elijah E. Cummings Lower Drug Costs Now Act, after the longtime congressman who died last week, heads to the floor for a vote after being considered by three House Committees – the Energy and Commerce, Labor and Education and, Ways and Means Committees. A full House […]

On Wednesday, October 2nd, Representative Ben McAdams visited the operations of Becton Dickinson in Sandy, Utah.  Representative McAdams was familiar with Becton Dickinson having visited previously when serving as Mayor of Salt Lake County.  Executives of Becton Dickinson including Rob Fredericks, Vice President and General Manager, Vascular Access Devices, initially met with Representative McAdams and […]

Yesterday, ProLung welcomed Salt Lake City Mayor Jackie Biskupski, partners, dignitaries, and members of Utah’s life sciences community as the company celebrated its move to a new location with a ribbon cutting ceremony.  ProLung CEO, Jared Bauer, addressed guests, announcing that the company’s move to the Labs at Northgate coincided with good news on recent […]

(Orem, UT) October 2, 2019_Turner Imaging Systems, a developer of advanced x-ray imaging systems, today announced the Company has received FDA 510(k) clearance for its Smart-C Mini-C Arm Portable Fluoroscopy and X-Ray Imaging Device.  What makes this device unique is its true mobility and portability. The patent-pending Smart-C weighs only 16 pounds so that it […]

The recent launch of a House impeachment inquiry is likely to throw a wrench into efforts to reach a deal in Congress on drug pricing legislation before the end of the year. Meanwhile, President Trump is pushing his own drug pricing proposals through regulation and executive order, including tying drug prices to an international price […]

Washington, DC – The Medical Device Manufacturers Association (MDMA), the Advanced Medical Technology Association (AdvaMed), the Medical Imaging & Technology Alliance (MITA) and a broad coalition of medical innovators, physician inventors, patient groups, and others sent a letter to congressional leadership today urging them to permanently repeal the medical device excise tax. “The United States is […]

15 August, 2019 by James Jardine, Staff Writer, MasterControl EDITOR’S NOTE: This is one in a series of highly popular GxP Lifeline blog posts that we are republishing in order to share their important subject matter and insights with a wider audience. If a person makes a mistake, a simple apology is often enough to fix […]

1 August, 2019 by James Jardine, Staff Writer, MasterControl The DIA 2019 Global Annual Meeting held June 23-27 in San Diego played host to approximately 7,000 pharmaceutical, biotechnology and medical device professionals from dozens of countries and more than 400 exhibiting providers of products and services that support the life sciences. As stakeholders gathered at […]

The Fine Print: University of Utah Engineers Develop Process to 3-D Print Cells to Produce Human Tissue Such as Ligaments and Tendons “’It will allow patients to receive replacement tissues without additional surgeries and without having to harvest tissue from other sites, which has its own source of problems,’ says University of Utah biomedical engineering […]

On Monday, September 16, 2019 the University of Utah Center for Medical Innovation kicked off its 10th Annual Bench to Bedside competition.  The Bench to Bedside program introduces students to the fascinating world of medical technology innovation.  The program has continued to grow in both scale an impact with more than 65 teams moving forward […]

On Wednesday October 2, Join RAPS for a 60-minute webcast offering tips, strategies and best practices for reducing barriers to approval by notified bodies. The presentation is based on lessons learned through work with dozens of organizations, across a variety of product types, that are writing CER literature reviews for regulatory submissions. Learn more and register here

On September 24, join the Commercial Service, World Trade Center Utah and the U.S. Small Business Administration (SBA) to learn how to grow and support your international business expansion into Mexico and Canada under the proposed new deal. Hear from Geri Word, Director of the Office of North America for the U.S. Department of Commerce […]

Salt Lake City, UT – August 26, 2019 – DiscGenics, Inc., a clinical stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its investigational cell […]

On Monday, August 19, Senator Mitt Romney (R-UT) held a roundtable discussion with leaders from more than 30 Utah-based medical device, pharma and diagnostic companies. Held at Biomerics’ new facility, Romney first toured Biomerics with CEO Travis Sessions, then engaged in a discussion with companies on a range of federal issues impacting Utah’s growing life […]

On Thursday, Vice President Mike Pence toured Merit Medical, where he delivered remarks to employees, local government officials and guests in support of the United States, Mexico, Canada Agreement (USMCA).  “Merit is a great example of a Utah life sciences company that is making its mark not only in the state, but around the globe,” […]

The 2019 Utah Life Sciences Summit brings together thought provoking experts and key members of the life sciences ecosystem for a robust dialogue on the challenges and opportunities facing our industry, including leaders from government, academia and the investor community. Network with some of the best and brightest in the business. Build invaluable strategic contacts. […]

The Medical Device Manufacturers Association (MDMA), along with AdvaMed and the Medical Imaging Technology Association, is circulating a letter for sign on by stakeholders who support repeal of the medical device tax. As you know, unless Congress acts, the tax will take effect January 1, 2020. MDMA spearheaded a similar broad-based coalition letter in 2009, […]

In its final FY 2020 Medicare Hospital Inpatient Prospective Payment System rule released on August 2, (see fact sheet), the Center for Medicare and Medicaid Services updated payment policies for medical devices that meet the FDA’s Breakthrough Devices designation. Devices that qualify would no longer be required to demonstrate evidence of “substantial clinical improvement” to […]

level to 65 percent. These changes represent significant wins for coverage and payment of innovative medical devices and are the latest in a series of payment policy victories that are the result of our multi-year advocacy efforts. Key highlights of the final rule include the following: Alternative NTAP Pathway for Breakthrough Devices and QIDPs Change […]

In an August 7 decision memo, the Centers for Medicare and Medicaid Services announced that Medicare will start covering nationwide CAR T-cell therapy for patients with certain cancers. “President Trump is committed to strengthening the Medicare program by ensuring that beneficiaries have access to new and potentially lifesaving treatments. As the first type of FDA-approved gene therapy, CAR T-cell […]

On Wednesday, a half dozen Utah life sciences companies loaded up power points, videos and sample products—from syringes and catheters to stroke technology and knee replacements—to talk with parents and students about career opportunities, as part of an evening Medical Innovations Pathways (MIP) orientation at Granite School District. Representatives from BD, Merit Medical, Nelson Labs, […]

On Wednesday, The Trump Administration announced a Safe Importation Action Plan – PDF* that outlines two potential pathways that could open the door to import lower cost drugs from Canada. However, no timeline has been specified for the plan, which will be formalized through agency rulemaking. Under Pathway 1, states, wholesalers or pharmacists could submit importation […]

Salt Lake City, UT (August 1, 2019) – Biomerics, a leading contract manufacturer for the interventional medical device market, is pleased to announce a merger with Northeast Laser & Electropolish (NLE), a Monroe, CT-based company. NLE provides contract manufacturing, laser processing, machining, and metal finishing services to a wide range of medical device manufacturers.  The merger […]

On Thursday, the Senate Finance Committee passed the Prescription Drug Pricing Reduction Act (PDPRA) aimed at cutting drug prices in Medicare Part B and Part D, and Medicaid. The bill, crafted by committee Chairman Chuck Grassley (R-IA) and ranking member, Ron Wyden (D-OR), passed on a bipartisan vote of 19-9, with nine Republicans voting against […]

July 15, 2019– SALT LAKE CITY –Recursion, a next-gen biopharma company combining automated, experimental biology with artificial intelligence to discover and develop drugs at scale, today announced the closing of a $121 million Series C financing. The round was led by Baillie Gifford’s flagship investment trust, Scottish Mortgage Investment Trust PLC, with participation by new […]

July 15, 2019– SALT LAKE CITY –Recursion, a next-gen biopharma company combining automated, experimental biology with artificial intelligence to discover and develop drugs at scale, today announced the closing of a $121 million Series C financing. The round was led by Baillie Gifford’s flagship investment trust, Scottish Mortgage Investment Trust PLC, with participation by new […]

Rebate Rule Withdrawn Yesterday, the Trump Administration withdrew a controversial proposed rule aimed at ending many of the rebates that drug companies pay to pharmacy benefit managers (PBMs) and insurers under Medicare. BioUtah, along with its national partners, the Biotechnology Innovation Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA), had supported the […]

On June 19, the House passed a package of health-related FY 2020 Appropriations bills. The legislation, H.R. 2740, contained the Labor, Health and Human Services, and Education Appropriations bill which includes $41.1 billion for the National Institutes of Health (NIH), a $2 billion increase from this year’s funding level. The NIH funding includes $500 million […]

Drug pricing legislation moving through Congress could force medical device manufacturers to report the value of product samples given to certain healthcare providers. This could include free samples a doctor uses when educating patients on device use. AdvaMed and the Medical Device Manufacturers Association, along with state-based affiliates, including BioUtah, are urging policymakers to exclude […]

On May 27, the Senate Judiciary Committee approved four bills with bipartisan support, all aimed at lowering prescription drug costs. Taken together, the bills are intended to curb certain abusive practices by drug patent owners, such as “patent hopping,” and “patent thickets,” which some policymakers believe are being used to extend market exclusivity and block […]

Earlier this week, U.S. Representative Ben McAdams (D-UT-4) sent a bipartisan letter to House Democrat and Republican leadership, signed by 35 House freshman, urging prompt action to end the 2.3% excise tax on the sale of medical devices. The current tax moratorium will expire December 31, unless Congress acts to block its implementation. Recognizing the […]