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 […]
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,” […]
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, 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 […]