Category Archives: Policy News
President Trump Signs Executive Order on Healthcare, Pre-existing Conditions
During a campaign event yesterday in Charlotte, North Carolina, President Trump signed an executive order on a range of health issues, including protecting people with pre-existing medical conditions, lowering prescription drug costs, increasing consumer choice, and providing greater transparency. The order also directs HHS Secretary Alex Azar to work with Congress to pass legislation to […]
Utah COVID-19 Grant Programs Update
BioUtah is pleased to provide the life sciences community with a current summary of state COVID-19 initiatives and grant programs managed by the Governor’s Office of Economic Development. Visit business.utah.gov/coronavirus to learn more. Coronavirus Prevention Messaging Grants Grants of up to $50,000, $75,000 or $250,000 for social media, targeted audience and mass media campaigns, respectively, […]
Trump Administration Releases COVID-19 Vaccine Distribution Strategy
The Administration on Wednesday released a detailed plan for the distribution of free COVID-19 vaccines beginning next year. The plan would prioritze vaccines for healthcare workers, essential employees, and high-risk indiividuals. From there, distribution would be expanded to the broader population. The plan includes two documents: documents: A strategic distribution overview along with an interim […]
President Signs New Executive Order on Drug Pricing
President Trump issued a new “Most-Favored-Nations” (MFN) executive order on September 13 that links U.S.-paid Medicare drug prices to those paid by other foreign countries. BIO President and CEO, Dr. Michelle McMurry-Heath, called the President’s action a “reckless scheme” that would hurt vulnerable seniors. The new order includes both Medicare Part B and Part D […]
Recursion Partners with Bayer to Accelerate Drug Discovery, Secures Series D Funding
In a double header of good news, Salt Lake City -based Recursion announced on Wednesday that the company has entered into a strategic collaboration agreement with Bayer to discover and develop new treatments for fibrotic diseases of the lung, kidney, heart and more. The agreement leverages Recursion’s AI drug discovery platform and Bayer’s small molecule […]
Clene Nanomedicine Raises Series D Financing of $42.5 Million
SALT LAKE CITY, August 26, 2020 – Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced that it has secured $42.5 million in a Series D financing. The round was led by SymBiosis II, LLC, a biotech-focused investment vehicle. Participants in the round included existing investors, as well as new institutional investors from South Korea […]
HHS Determines FDA Can’t Regulate Lab-Developed Tests Without Formal Rulemaking
HHS said yesterday that it has determined that the FDA will not require premarket review of laboratory-developed tests (LDTs) without notice-and-comment rulemaking. This means that the FDA cannot expand its authority over LDTs through guidance and other informal issuances. As reported by Genome Web, it also means that laboratories will be able to “offer LDTs […]
BioUtah and Utah Biotech/Biopharma Companies Raise Concerns About Impact of Trump’s “Most-Favored-Nation” Drug Pricing Order on Innovation
BioUtah, along with 10 Utah biotech and biopharma companies, have sent letters to Utah’s U.S. Senators and Representatives urging opposition to the President’s directive to impose “most-favored nation” pricing on Medicare Part B drugs. The letter notes that if the executive order moves forward, investment dollars for Utah’s smaller drug discovery companies could dry up […]
Recursion and University of Utah Launch Altitude Lab, Largest Life Sciences Incubator in Utah
On August 11, Altitude Lab, founded by BioUtah member Recursion and the University of Utah’s Center for Technology & Venture Commercialization (TVC), announced its first resident companies and opened applications for its unique collaborative facility and program. The incubator, a state-of-the-art 14,500 square foot lab facility, will offer resident companies workshops, mentoring, and non-dilutive funding […]
House Bill Introduced to Provide COVID-19 Economic Relief to Startups
Bipartisan legislation to help entrepreneurs and startups navigate the economic perils of COVID-19, has been introduced in the U.S. House of Representatives. The bill, the IGNITE American Innovation Act (H.R. 7917), introduced by Reps. Dean Phillips (D-MN) and Jackie Walorski (R-IN), will allow many small companies that have not benefited from CARES Act relief to […]
RAPS Convergence 2020 — live online!
Convergence is the largest annual gathering of regulatory professionals, regulators, scientists, and innovators from around the world and the only US event that is exclusively dedicated to the regulatory profession. And this year, the community will converge online with two virtual registration options that will allow attendees to experience Convergence live online from the safety […]
Senate Republicans Release HEALS Act – COVID-19 Stimulus Package
Earlier this week, Senate Majority Leader Mitch McConnell released the Republican version of a fourth COVID-19 package (or as some say, a second round of a CARES Act stimulus bill). The bill, titled the Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act is actually a collection of bills. Highlights include another round of $1200 […]
