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 […]
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” […]
