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 […]
On June 26, the Senate Health, Education, Labor and Pensions Committee (HELP), approved by a bipartisan vote of 20-3, the Lower Health Care Costs Act of 2019 (see Roll Call article), which addresses a wide array of issues from prescription drugs to surprise medical bills. Senator Mitt Romney (R-UT) serves on the HELP Committee and` […]
Study Represents Largest DNA Mapping Effort Undertaken in U.S. From a Single Population Media Contacts: Intermountain Healthcare: deCODE genetics: Brad Gillman: brad.gillman@imail.org/385-315-8949 Jon Gustafsson: jon@decode.is/+354 664 1905 REYKJAVIK, ICELAND, and SALT LAKE CITY – Intermountain Healthcare and deCODE Genetics have announced a major global collaboration and study focused on discovering […]
The Senate Judiciary Subcommittee on Intellectual Property held hearings on June 4 and 5, on a bipartisan draft bill released May 22 by subcommittee chair, Senator Thom Tillis (R-N.C.), and ranking member, Senator Chris Coons (D-Del.) (see the press release here), that would amend current patent law to expand eligible subject matter. A third hearing […]
Salt Lake City – BioUtah and Utah’s life sciences industry is proud to congratulate one of its own—Fred Lampropoulos, founder and CEO of Merit Medical—who will receive the Salt Lake Chamber’s 40th Giant in our City award today, during an evening ceremony at the Grand America Hotel. The award honors those with exceptional and distinguished […]
We’re excited to announce that as of May 1, BioUtah has opened new offices downtown at 230 East South Temple, Suite 100, in the Price Real Estate building. The new office space will allow us to raise the visibility of BioUtah, better serve our members, and continue to advance Utah’s life sciences industry. BioUtah members […]
Earlier this week, on May 6, Tolero Pharmaceuticals, a biopharma company discovering novel cancer therapies, hosted a tour of their Lehi research lab for Congressman John Curtis (R-UT-3). Following the tour, and in partnership with BioUtah and National BIO, Curtis held a roundtable discussion with life sciences executives from Tolero, PhotoPharmics, PolarityTE and Thunder Biotech. […]
BioUtah and life sciences companies gathered at the Utah State Capitol on April 30 to celebrate the Medical Innovations Pathways (MIP) Class of 2019. A total of 52 high school seniors from Canyons, Davis, Granite, Jordan and Tooele school districts were awarded the Medical Innovations Certificate during a graduation ceremony presided over by Kimberlee Carlile, […]
April 9, 2019 If your company leases office space, by now (April) you should have received–or will soon be receiving–your annual operating expenses reconciliation statement from your landlord. Here I will briefly explain what these statements are and recommend 6 steps you should take before paying your reconciliation invoice. Most office leases require each tenant […]
SALT LAKE CITY—Kelvyn Cullimore, President and CEO of BioUtah, issued the following statement on introduction in the House of Representatives of the “Protect Medical Innovation Act of 2019,” H.R. 2207, introduced by Reps. Ron Kind (D-Wis.) and Jackie Walorski (R-Ind.), to permanently repeal the medical device tax. “BioUtah applauds the bipartisan introduction in the House […]
What is Your Signature on the Risk Radar? Notwithstanding the benefits and goodness of Life Sciences products, regulators will worry about the risk posed by these. It is part of their role and obligation in the larger scheme of things. For the organization, it is a delicate balancing act. The force field is multi-dimensional […]
Approximately 90 attendees joined us on March 28, 2019 for this event, “Transitioning to New EU MDR & EU IVDR – Post-Market Surveillance, Clinical and Usability Studies,” hosted by MasterControl. Participants were first able to hear from the following speakers: * Robert Wolfarth, Chapter Chair of new RAPS Utah chapter; and Senior Manager, Regulatory Affairs, Merit […]
BioUtah’s President and CEO, Kelvyn Cullimore and Navigen, Inc. CEO and BioUtah board vice chair, Brandi Simpson, were in Washington, D.C. this week to help advocate for Utah’s growing biotechnology and pharma sectors. On April 3, BioUtah cohosted a congressional briefing titled From Labs to Patients: The Discovery of New Treatments and Cures. The briefing […]
From the editors of The Gray Sheet After a week of speculation as to who will succeed US FDA Commissioner Scott Gottlieb when he steps down next month, Health and Human Services Secretary Alex Azar announced during a congressional hearing that National Cancer Institute Director Ned Sharpless will step in as acting commissioner. Norman “Ned” […]
Salt Lake City – Kelvyn Cullimore, President and CEO of BioUtah, issued the following statement after the introduction of the Protect Medical Innovation Act, bipartisan legislation introduced by Senators Pat Toomey (R-PA) and Amy Klobuchar (D-MN), to permanently repeal the medical device tax. “BioUtah and its Utah-based members of the life sciences industry applaud the […]
World Trade Center Utah, partnered with the Governer’s Office of Economic Development, is organizing an international trade mission to Italy and France this summer. The trade mission, led by Governor Gary R. Herbert, will take place from June 14-22, 2019. The event will present a unique opportunity for life sciences companies to expand their footprint […]
On February 7, BioUtah industry partners participating in the Medical Innovations Pathways program welcomed new students at a special “Welcome Event” at Granite Technical Institute. The event was geared to help students learn more about Utah’s life sciences companies and prepare them for their on-site job shadows. Work-based experience that links classroom learning to real-world […]
On November 1, 2018, at the BioUtah Utah Life Sciences Summit (ULSS). the Regulatory Affairs Professionals (RAPS) Utah Chapter was officially announced by chapter chair Robert Wolfarth, senior manager of regulatory affairs for Merit Medical. Last week, members of the growing Chapter gathered to celebrate their launch and kick-off the year ahead. “This new RAPS […]
Newswise— The Coalition for the Life Sciences, on behalf of the Congressional Biomedical Research Caucus, is pleased to announce Congressman John Curtis (R-UT) as the newest co-chair of the Caucus. He joins Reps. Jackie Speier (D-CA), Steve Stivers (R-OH), and Steve Cohen (D-TN) as leaders of the 78-member bipartisan Caucus. “It is an honor to […]
Yesterday, Utah’s life sciences companies participating in the Medical Innovations Pathways (MIP) program (www.medicalinnovationspathways.com), gathered at Granite School District as part of the district’s annual Career and Technical Education Open House. The Open House offers students a glimpse into a board range of industries. Representatives from BD, Edwards Lifesciences, Merit Medical, Nelson Laboratories, and Stryker […]
