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 […]
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 […]
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 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, 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 […]
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 […]
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 […]
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 […]
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 […]
Last Friday, President Trump signed four executive orders aimed at lowering drug prices, including an order that would set up a “most favored nation” (MFN) pricing model for Medicare Part B drugs, effectively imposing foreign price controls on critical medicines for seniors. The goal, Trump said, is to “end global freeloading on the backs of […]
As reported by The Hill, “White House and Senate Republicans on Thursday reached a “fundamental agreement” on a coronavirus package…” Among other items, the agreement includes: Another round of $1200 in direct payments to individuals making up to $75,000 Replacing the current $600 in federal unemployment benefits with a 70% match of a worker’s wages […]
While the drug pricing issue has been sidelined amid the COVID-19 pandemic, President Trump is now returning to the issue with several executive orders that he is expected to sign today. According to a report by The Hill, Republican lawmakers have been invited to a presidential event on drug pricing today at 3 p.m. at […]