Recent BioUtah News & Events

The Senate on Thursday passed President Trump’s United States-Mexico-Canada Agreement (USMCA) by a wide bipartisan vote of 89-10. The USMCA, which rewrites the North America Free Trade Agreement, will now be sent to the President’s desk to be signed into law. The President is expected to sign the measure next week. Both Utah Senators, Mike […]

BioUtah/TVC 2020 Entrepreneur & Investor Life Science Summit Salt Lake City, Utah – January 17, 2020 – BioUtah, Utah’s only trade association dedicated solely to the life sciences, along with the Center for Technology & Venture Commercialization at the University of Utah, today announced distinguished speakers and sessions for the 2020 Entrepreneur & Investor Life […]

Antimicrobial Resistance (AMR) is a public health crisis, but developing new classes of antibiotics to combat drug resistant bacteria is challenging on many levels. Last month, the New York Times reported on the struggles facing companies that are researching new antibiotics. In November, the Centers for Disease Control and Prevention (CDC) released a report, Antibiotic Resistance […]

Sen. Grassley Calls on Pelosi to Support His Bill Conservative Group Backs GOP Drug Pricing Alternative As we head into 2020 election season, Democrats and Republicans alike will be working to convince voters that they have the right “prescription” to lower drug costs. At present, several different approaches are circling. With the passage of H.R. […]

On December 30, the FDA issued a notice (see the FDA’s Federal Register notice)  that exempts certain class I and II medical devices from 510(k) premarket notification requirements. The exemptions, some of which are limited, cover a wide range of different products, including clinical chemistry test systems, clinical laboratory instruments, clinical toxicology test systems, hematology […]

Congress returned yesterday with a number of big ticket items on their plate, including drug pricing and the U.S.-Mexico-Canada Agreement (USMCA), both of which have implications for Utah’s life sciences industry. Drug Pricing As the House of Representatives was passing the Democrat drug pricing plan, H.R. 3, the Lower Drug Prices Now Act, in the […]

SALT LAKE CITY–(BUSINESS WIRE)–BioUtah applauds congressional action to permanently repeal the 2.3% excise tax on the sale of medical devices, first enacted as part of the Affordable Care Act in 2010. Earlier in the week, the U.S. House of Representatives voted to repeal the tax as part of a $1.4 trillion FY 2020 government spending […]

On December 18, HHS and the FDA issued a Noticed of Proposed Rulemaking (NPRM)  that would allow states to import prescription drugs from Canada. The proposed rule follows an Administration announcement in July that HHS would be examining pathways for safe drug importation. 

After nearly a decade-long fight, and disruptive, short-term reprieves, Congress has finally permanently repealed the medical device tax. On Tuesday. BioUtah alerted our life sciences community about a vote in the House to end the tax as part of a larger FY 2020 spending bill (repeal provision is on page 585). Yesterday, the Senate cleared […]

Yesterday, top congressional leaders and the White House unveiled a $1.4 trillion FY 2020 government spending agreement that will fully repeal the 2.3% medical device tax, first enacted as part the Affordable Care Act in 2010. “This is a big win for Utah’s medical device industry and most importantly, a big win for patients whose […]

On Thursday, the Democrat-led House passed H.R. 3, the Lower Drug Costs Now Act, by a vote of 230-192. The bill, a priority for Speaker Pelosi, mandates extensive price controls and passed largely along party lines. Only two Republicans in marginal districts voted for the legislation.

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 […]