Recap of Australia Clinical Trials Event

In conjunction with the Governor's Office of Economic Development and Southern Star Research, yesterday, BioUtah presented a seminar on "Conducting Early-phase Clinical Trials in Australia." The seminar was presented by Daniel Evans, business development director for Southern Star Research, located in Australia. Southern Star has several clients in Utah who are currently running clinical trials “down under." Over 25 people registered to hear the presentation, which explained how Australia has not only eliminated red tape but also provides significant financial incentives for companies to perform clinical trials in Australia. After meeting conditions set by the Australian government, companies can apply for a cash refund of up to 43.5% of the cost of their clinical trials. To learn more about this, we link below to the slide deck used in the seminar.

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Halia Therapeutics Completes Enrollment in Phase 2a Clinical Trial of HT-6184 for MDS

Halia Therapeutics has completed enrollment for its open-label Phase 2a clinical trial evaluating HT-6184 (Ofirnoflast) in patients with lower-risk Myelodysplastic Syndrome (MDS) who are refractory to, intolerant of, or ineligible for erythropoiesis-stimulating agents.

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Arcutis’ ZORYVE® (roflumilast) Topical Foam 0.3% Approved by FDA

BioUtah member, Arcutis Biotherapeutics, announced the U.S. FDA has approved the supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) topical foam 0.3% for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. ZORYVE foam is a once-daily, steroid-free topical and is now widely available as a treatment for plaque psoriasis. Congratulations to CEO Frank Watanabe and the Arcutis team!

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Renalytix Growing Collaboration with New York Kidney & Hypertension Medicine

Renalytix is collaborating with New York Kidney & Hypertension Medicine to expand access to kidneyintelX.dkd, the only FDA-approved and Medicare-reimbursed prognostic test to support early-stage risk assessment in patients with type 2 diabetes and chronic kidney disease stages 1-3b.

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CancerVax Launches New StartEngine Fundraising Campaign

CancerVax has launched a new funding campaign on StartEngine. For a limited time, Early Bird investors can receive up to 30% in bonuses when investing within the first two weeks of the campaign. Funds raised will help the company continue its mission to develop a revolutionary Universal Cancer Treatment Platform.

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CancerVax's New Chief Scientific Officer, Dr. George Katibah

CancerVax has announced that Dr. George Katibah will serve as the company’s chief scientific officer. Dr. Katibah is an expert in oncology, immunology, host-pathogen interactions, and personalized medicine.

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CancerVax Scientists Featured on Cytiva’s Discovery Matters Podcast Discussing Universal Cancer Vaccine Platform

CancerVax scientists, Dr. George Katibah and Dr. Adam Grant, were recently featured on Cytiva’s podcast series, Discovery Matters. The episode highlights CancerVax’s revolutionary approach to immunotherapy that can universally target and destroy cancer cells.

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Gardner Law Recaps Presentation: "Tapping into FDA: Regulatory Hot Topics"

At the Saison-al Session hosted by BioUtah member, Gardner Law, three of the firm’s regulatory experts—Nathan Downing, Rebecca Zadaka, and Brynn Stanley—delivered a high-impact, fast-paced update on what’s shifting at the FDA. Their 30-minute session covered key enforcement trends, food ingredient oversight, global inspections, advertising scrutiny, and deregulation efforts—providing practical insights for FDA-regulated companies navigating compliance challenges in an uncertain environment..

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Myriad Genetics Announces Early Access to the FirstGene Multiple Prenatal Screen

Myriad Genetics has launched early access to the FirstGene™ Multiple Prenatal Screen. The company will begin a large study that will simultaneously deliver reports to patients while generating clinical validity and clinical utility evidence.

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Don't Miss BioUtah's Exclusive Biosphere Magazine Promotional Opportunity

Production of the 2025 edition of BioUtah's exclusive Biosphere magazine is now underway. The current publication allows for up to 12 pages of acknowledgments (the term for advertising used by non-profit entities) available for this year's magazine. To claim one of these few coveted spots in this year's magazine, click the link below and get started today.

See the 2025 Prospectus »

University of Utah Founders Day Distinguished Alumni Awards

The University of Utah Office of Alumni Relations annually presents its Founders Day Distinguished Alumni Awards to alumni for their outstanding professional achievements, public service, and/or commitment to the U. Nominations are now being accepted. Click through for more information.

The award presentations will take place during the Founders Day celebration at the Cleone Peterson Eccles Alumni House in February 2026.

Submit a Nomination »

Utah Business: Nominations for Innovation Awards Open

The program recognizes the state’s vibrant community of innovators — from startups to established companies — and their breakthrough creations. The awards program aims to build the state’s economy by acknowledging and rewarding the creative minds fueling innovation within it.

Deadline for submissions is July 9.

Submit Nomination »

BioUtah welcomes AstraZeneca as the newest Bronze Elite Member of BioUtah. AstraZeneca is a well-known global, science-led, patient-focused pharmaceutical company emphasizing products for oncology, chronic disease, and rare disease (through subsidiary Alexion). Generating $54B in revenue and employing almost 95,000 people worldwide, AstraZeneca is known for drugs such as Crestor, Farxiga, Breztri, and Calquence. James Parker, director of Corporate and State Government Affairs, is a resident of Utah and an active participant in BioUtah events. BioUtah is proud to include AstraZeneca as a member.

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The Good Medicine Podcast Features Denali's Dr. Ryan Watts

This week, Dr. David Bearss sits down with Dr. Ryan Watts, CEO of Denali Therapeutics, to unpack the cutting-edge science behind treating diseases like Alzheimer’s, Parkinson’s, and ALS.

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ODP Business Solutions (Office Depot) is a leading provider of business services and supplies, products, and technology solutions to small, medium, and enterprise businesses.

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Big PR Features at Member Pricing: Be Heard at BIO International (and Beyond!) with Content Carnivores

Content Carnivores, a cutting-edge marketing firm, has valuable resources to help you elevate your company's profile, whether you’re attending the upcoming BIO Conference or just looking to up your game. They specialize in big PR features, like targeted reporter outreach, and news portal syndication, at mom-and-pop pricing.

Hundreds of companies, universities, and BioUtah have used Content Carnivores to get their story out. View examples below.

BioUtah members receive exclusive, discounted pricing. For more information: Chelli@ContentCarnivores.com

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Examples:
BioUtah Press Release »
Pacylex Pharmaceuticals Press Release »
GeoVax Lab Press Release »

FDA Declines to Appeal Court Order that Stopped LDT Final Rule

The FDA will not appeal a recent U.S. District Court decision that set aside the agency’s final rule aimed at increasing its authority over lab-developed tests.

“This decision should finally conclude the FDA’s unwarranted and overreaching attempts to assert regulatory authority over LDTs,” AMP President Jane Gibson said in an emailed statement.

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FDA Launches Agency-Wide AI Tool to Optimize Performance for the American People

The FDA has officially launched Elsa, a generative AI tool designed to help employees, from scientific reviewers to investigators, work more efficiently. This innovative tool modernizes agency functions and leverages AI capabilities to better serve Americans.

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At FDA Cell and Gene Roundtable, Officials Look for Ways to Cut Red Tape

At a June 5 cell and gene therapy roundtable hosted by the FDA, HHS Secretary RFK, Jr., asked the assembled scientists and advocates to provide a list of regulations they’d like to see gone.

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CEO Forums: An FDA Listening Tour to Engage Pharma CEOs

The FDA is conducting a national listening tour to meet directly with pharmaceutical and biotech CEOs. Held in major innovation hubs across the country, the CEO Forums will be led by FDA Commissioner Marty Makary, MD, MPH, along with principal deputy commissioner Sara Brenner, MD, MPH, and director of the FDA’s Center for Biologics Evaluation and Research, Vinay Prasad, MD, MPH.

These forums, below, are part of a new initiative to get direct input from the drug industry and biotech on how the FDA can modernize its regulatory framework.

• Silver Spring, MD: June 5, 2025, 3:00-5:00 PM
• San Francisco, CA: June 12, 2025
• San Diego, CA: June 13, 2025
• Boston, MA: June 17, 2025
• New York, NY: July 30, 2025
• Atlanta, GA: TBD

*Upon registration, the FDA will provide additional details of specific locations and times to each accepted participant.

Register »

USTR Seeks Comments Regarding Foreign Nations Freeloading on American-Financed Innovation

In follow-up to President Trump's Executive Order on Most-Favored-Nation drug pricing, the Office of the U. S. Trade Representative invites public comments regarding any act, policy, or practice that may be unreasonable or discriminatory and that has the effect of forcing American patients to pay for a disproportionate amount of global pharmaceutical R&D.

Comments must be received by June 27, 2025.

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HHS, Labor, Treasury Departments Issue RFI, Updated Guidance on Healthcare Price Transparency

The departments jointly issued a Request for Information, seeking public input on how to improve prescription drug price transparency. The RFI seeks input regarding the prescription drug price disclosure requirements and more.

Comments must be received by July 2, 2025.

CMS Fact Sheet »

Updated Guidance »

BioUtah Legislative Policy Call

BioUtah held its monthly policy call on May 22 reviewing activity of the Utah state legislature as well as policy developments at the federal level. 

To view the agenda from the May 22 call, click here.

To sign up for future calls in 2025, click here.

Discuss Your SBIR/STTR Funding Needs with a Program Director

Are you seeking SBIR/STTR funding to help commercialize your cancer technology? Before you apply, we encourage you to schedule a one-on-one conversation with an NCI SBIR program director to:

• Get questions answered about SBIR/STTR funding and resources.
• Learn which opportunities can support your small business.
• Receive guidance on approaching the application process.

To get connected with a program director, email ncisbir@mail.nih.gov with an abstract, specific aims, or a quad chart describing your cancer technology.

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Non-dilutive Funding Monthly Grant Webinar

June 19, 2025
10:00 AM MT

G2G Consulting hosts a monthly webinar to review the latest federal non-dilutive funding opportunities for the life sciences industry. The webinar is free for BioUtah members.

Register »

Non-dilutive Funding Monthly Grant Report

The most recent GBG report has several non-dilutive government funding opportunities, notices of special interest, and other opportunities.

Access Report »

STEP Grants Available to Help Cover Costs of International Trade Shows and Trade Missions

Utah has received $500,000 to support export growth among small businesses as part of the SBA's State Trade Expansion Program (STEP). The grant aims to enhance global success for Utah companies and is administered by World Trade Center Utah in partnership with the Governor’s Office of Economic Opportunity.

Grants – World Trade Center Utah »