Category Archives: Policy News

CMS Proposes MCIT Repeal On September 13, CMS issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) pathway initally finalized in a January 14, 2021 rule.  The MCIT pathway would have provided four years of immediate Medicare coverage for FDA-designated breakthrough medical devices and diagnostics that have been market authorized – […]

Congressional committees this week got down to business writing the details of the Biden Administration’s $3.5 trillion “Build Back Better” reconciliation bill. Of particular interest to the life sciences industry was consideration of drug price control provisions in the House Energy and Commerce and Ways and Means Committees. In its version of “Build Back Better,” […]

The Saragene test kits approved by the CDSCO use the Company’s patented CoPrimer™ technology for the qualitative detection of these mosquito-borne viruses. According to the World Health Organization, the global incidence of dengue has grown dramatically in recent decades to become a leading cause of death in some Asian and Latin American countries, with 70% […]

The Biotechnology Innovation Organization (BIO) believes that legislation and public health policies to address this pandemic and the use of FDA authorized and approved COVID-19 vaccines should reflect the best available scientific evidence in order to improve access to and uptake of COVID-19 vaccination. In the U.S., vaccination requirements for school entry, daycare entry, and […]

Nusano, a health-tech company aiming to revolutionize uranium-free radioisotope development and production in various diagnostic and therapeutic medical applications, is opening an office in Utah. The Governor’s Office of Economic Opportunity (Go Utah) announced the news July 8, noting that the company will add up to 92 new high-paying Utah jobs in the next 15 […]

Phoenix PharmaLabs, Inc. has completed a second successful round of financing raising $1.07 million via the Netcapital equity funding portal to continue development of two non-addictive opioids to treat acute and chronic pain. “More than a thousand investors, many of whom invested in our previous funding, participated in this offering, indicating to us they did […]

In last week’s BioUtah News and Events, we highlighted the Biden Administration’s formation of a task force to address a range of supply chain issues. This week, we share the findings of the administration’s 100-day assessment of critical supply chains, undertaken pursuant to President Biden’s February 2021 “America’s Supply Chains” executive order addressing supply chain […]

Elute has received an Investigational Device Exemption (IDE) authorization from the FDA to use its EP Granules with TobramycinTM in a pivotal clinical trial. This IDE investigates the use of a resorbable bone void filler that delivers a broad-spectrum antibiotic in the surgical treatment of bone infections following hip or knee replacements. This is the […]

On Tuesday, the U.S. Senate passed the Endless Frontier Act to boost U.S. innovation and out-compete China. The bill passed the Senate by a vote of 68-32. The bill would provide $120 billion to the NSF, DOE and NASA to support research and develoopment in key technology areas critical to our national security, including biotechnology […]

Last August.under the Trump Administration, HHS announced that FDA would not have premarket review authority and oversight over laboratory developed tests (LDTs), including for COVID-19 tests and EUAs. Recently, House Energy and Commerce Committee Democrats sent a letter to HHS Secretary Becearra uring that he reverse the decision of the previous administration and reinstate FDA […]