March 20, 2023

This week’s newsletter included:

Acadia Pharmaceuticals Announces U.S. FDA Approval of Daybue™ (trofinetide) for the Treatment of Rett Syndrome in Adult and Pediatric Patients Two Years of Age and Older
Utah Company, KUDA Therapeutics, Awarded $2 Million Grant for Cancer Research
BD Receives FDA 510(k) Clearance for First-of-Its-Kind High-Throughput Diagnostic Test for Infectious Vaginitis
Women Tech Council Recognizes Four BioUtah Members
100 Companies Championing Women Nomination Application

Featured New Member

Established by Dr. David Bearss and Dr. E. Lynne Kelley, Xenthera is a private oncology focused clinical stage biopharma company founded in 2022. Xenthera has focused on the discovery and novel development of therapeutics for solid tumor oncology targets to improve the lives of patients fighting cancer. Their first drug is proceeding with Phase 1 clinical trials after receiving Approval to Proceed from FDA in August 2022. They have many other assets under evaluation.

BioUtah News

Acadia Pharmaceuticals Announces U.S. FDA Approval of DAYBUE™ (trofinetide) for the Treatment of Rett Syndrome in Adult and Pediatric Patients Two Years of Age and Older

BioUtah elite member, Acadia Pharmaceuticals has received FDA approval for DAYBUE™ (trofinetide), for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. DAYBUE is the first and only drug approved for the treatment of Rett syndrome.

"Today marks an important milestone for the Rett community and Acadia. As the first FDA-approved drug for the treatment of Rett syndrome, DAYBUE now offers the potential to make meaningful differences in the lives of patients and their families who have lacked options to treat the diverse and debilitating array of symptoms caused by Rett syndrome,” said Steve Davis, Acadia’s chief executive officer.

Utah Company, Kuda Therapeutics, Awarded $2 Million Grant for Cancer Research

Utah company Kuda Therapeutics has received a Phase II grant from the National Cancer Institute for $2.05 million to continue research on novel therapies targeting kidney cancer through the competitive Small Business Innovation Research (SBIR) program.

The clear cell subtype of kidney cancer, the most common and aggressive form of this disease, is among the most drug resistant of solid tumors and is uniquely dependent upon the hypoxia-inducible factors (HIF) for its continued growth and progression.

"KD061 is a novel first-in-class molecule that inhibits HIF-1/2α and triggers cell death via ferroptosis, thus exploiting two specific vulnerabilities of kidney cancer,” said Dr. Mei Yee KohKoh, Kudo co-founder and CEO.

BD Receives FDA 510(k) Clearance for First-of-Its-Kind High-Throughput Diagnostic Test for Infectious Vaginitis

BD has received 510(k) clearance from the FDA for the BD Vaginal Panel on the BD COR™ System, a comprehensive diagnostic test that directly detects the three most common infectious causes of vaginitis, using BD's high-throughput molecular diagnostic platform for large laboratories.

"Most women have a vaginal infection during their lifetime and millions of them receive inadequate treatment," said Nikos Pavlidis, vice president of Diagnostics for BD... The BD Vaginal Panel can help end the cycle of repeat visits, misdiagnosis and ineffective treatment for the millions of women suffering from vaginitis.”

Women tech council recognizes four bioutah members

Four BioUtah members were recognized on Women Tech Council's 2023 Shatter List, including:

Intermountain Health
Myriad
Recursion
Zion's Bank

The Shatter List showcases technology companies building inclusive cultures with meaningful measures that help women break and surpass the glass ceiling in technology.

"Women drive success and innovation at all levels," said Myriad in a statement. "Achieving gender equity begins with prioritizing our teammates' success, regardless of gender."

100 Companies Championing Women Nomination Application

As part of the new Inspire In Utah initiative, 100 Companies Championing Women focuses on recognizing and highlighting the stories of 100 Utah companies that offer family-friendly policies and practices, as well as women-specific initiatives known to impact the recruiting, hiring, retaining, and advancing of women employees, managers, and leaders.

All Utah companies are invited to provide their information to be nominated for inclusion in the initiative.

Featured Deals

Member Deal: PSC BIOTECH

PSC Biotech® consultants act as a seamless extension of your company to assist you in producing the highest quality products. Specializing in quality and validation, PSC Biotech® offers services in Commissioning, Qualification and Validation (CQV) Planning, Document Generation and Execution Support, Computer System Validation and Assurance, and IT Infrastructure support, Regulatory Affairs, Quality Assurance, Audits and Gap Analysis, Calibration, Engineering, and Project Management. Contact PSC Biotech® now for assistance.

View Offers to BioUtah Members »

Policy Updates

Prime movers lab suggests five policy breakthroughs needed to unleash the us innovation economy

In a recent article published in Medium, Gavin Mathis of Prime Moves Lab, and former advisor to BioUtah, suggests five policy breakthroughs that Congress could pass to accelerate America’s breakthrough science startup ecosystem. Those breakthroughs include:

National Environmental Policy Act Permitting Reform
Increase Federal R&D to 1960s Levels
Fund CHIPS and Science Act at Authorized Levels
High-Skill Immigration Reform
FDA Needs to Treat Aging as a Disease

Ranking Member Cassidy, Chair Sanders, Romney, Casey Seek Information from Stakeholders on PAHPA Reauthorization

U.S. Senators Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, Bernie Sanders (I-VT), chair of the HELP Committee, Mitt Romney (R-UT), and Bob Casey (D-PA) requested input from public health officials, health care providers, and other stakeholders on policies the Committee should consider during the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA). The senators hope to use the input during the reauthorization process to enhance PAHPA and improve the nation’s preparedness for future health crises.

PAHPA expires on September 30, which is the end of fiscal year 2023.

Read the full request here or below.

All submissions to this RFI should be sent to PAHPA2023Comments@help.senate.gov by COB on March 29.

CMS Requests Input on Small Biotech Exception to Drug pricing Negotiations

CMS has posted an Information Collection Request (ICR) on the Small Biotech Exception to the Medicare drug pricing negotiation program established under the “Inflation Reduction Act.” Comments must be received by March 27.

The legislation exempts “small biotech drugs” from negotiation until 2028, defined as those which account for 1% or less of Part D or Part B spending and account for 80% or more of spending under each part on that manufacturer’s drugs, as well as drugs with Medicare spending of less than $200 million in 2021 (increased by the CPI-U for subsequent years) and drugs with an orphan designation as their only FDA-approved indication.

BioUtah Events

MDMA 2023 Annual Meeting

April 26-28, 2023

Intercontinental - The Wharf
801 Wharf St SW
Washington, D.C. 20024

Members $895
Non Member $1,195

MDMA’s 2023 Annual Meeting will cover key issues impacting the United States’ leadership position in medical technology innovation, and how we can all help shape the regulatory and legislative agendas. Members of Congress, policy makers and industry leaders will share what they are working on for 2023 and beyond.

Use the promo code "STATE" to receive the BioUtah member discount of $100 off the non-member rate.

Fireside Chat Webinar: A Potential Cure for Degenerative Disc Disease

March 21, 10:00 AM MT

Join this Force for Knowledge Fireside Chat to learn about DiscGenics’ potential breakthrough in the treatment of degenerative disc disease. Clinical trials have shown that their treatment not only reduced back pain and improved quality of life, but also resulted in an increase in disc volume.

The expert panel includes Utah’s own Flagg Flanagan, CEO and chairman of DiscGenics. Flagg is an entrepreneur, executive and advisor with more than 30 years of experience in the surgical device and biopharmaceutical fields. The panel also features distinguished surgeons and patient advocates.

Zion's Bank: Going Foreign and Funding your International Opportunities

April 12, 10:00 AM - 12:00 PM MT

Zions Bank Technology Center
8170 South Bingham Junction
Midvale, UT 84047
Light Breakfast

Zion's Bank, International Banking, is holding several in-person summits this year focusing on internationalizing and funding your business.

Mayo Clinic Symposium on Regenerative Medicine & Surgery 2023

April 2- 5, 7:15 AM - 8:00 PM MT

Registration fee: $650

This course offers Live (in-person) and Livestream (virtual) attendance options. Poster abstract applications are being accepted.

Mayo Clinic leaders strongly believe that regenerative science, medicine and surgery are vital pillars of tomorrow’s healthcare. By harnessing the potential of regenerative medicine, Mayo Clinic will create new models of healthcare and transform the practice of medicine and surgery. The unique character of Mayo Clinic’s Center for Regenerative Medicine is the expansive nature of its priorities with focus areas including advanced biomanufacturing, practice advancement in a multitude of specialties (i.e., orthopedics, oncology, cardiovascular medicine, neurosciences, and transplant) and workforce development.

BIO International Convention

June 5-8, 2023

Boston Convention & Exhibition Center
Boston, MA

Stand Up for Science at BIO 2023. It’s time to inspire, honor, and recognize the true value of the breakthrough work biotech performs for society. Today. And every day. Well into the future.

Funding Opportunities

FDA Announces Funding Opportunity to Support Pediatric Medical Device Development

The FDA has announced a funding opportunity through the Pediatric Device Consortia (PDC) grants program open through Wednesday, March 29, 2023, 11:59 PM ET. The agency funds this program to advance the development of medical devices for children. These nonprofit consortia provide experienced regulatory, business planning and device development services, such as intellectual property advising, prototyping, engineering, laboratory and animal testing, and grant writing. In addition to key advising services, the consortia also provide critical funding to innovators for pediatric medical device development work across the total product life cycle.

Information about the Pediatric Device Consortia grants program can be found on the FDA’s website.

More »

NON-DILUTIVE FUNDING: MONTHLY G2G REPORTING SERVICE WEBINARS

next webinar: april 21, 8:00 am mt

BioUtah has partnered with G2G Consulting, a Washington DC-based firm, to track the announcement of government grants available for life sciences companies. G2G recently released their March report with 144 new non-dilutive funding opportunities. Please click here to review that report.

Every third Friday of the month, G2G hosts this online event to give life sciences companies the chance to learn about non-dilutive funding opportunities, such as grants and BAAs that could accelerate company growth.

Here are some highlights from the March report:

March 28-29 – Operational Medicine Symposium in San Antonio – there’s still time to register for this military medical conference to network, engage and get your innovative medical solutions noticed by military leaders, senior medical officials, program managers, clinicians, and government leaders. G2G is attending and would love to connect if you are going too.
Joint Warfighter Medical Research Program (GBG p.13, line47) – for companies with existing R&D initiatives supported by DoD that are close to achieving objectives but need additional funds to get projects over the finish line. Funds cannot be used for new projects or basic research.
Women’s Health (GBG p. 15, line 60) – NIH will be accepting proposals on chronic conditions that disproportionately affect populations of women who are understudied, underrepresented, and underreported in biomedical research.

International Trade

Emerging SE Asia

March 22, 8:30 AM MT

World Trade Center Utah
60 E South Temple, Ste 300
Salt Lake City, UT

Dress Code: Business casual

Southeast Asia offers Utah tech companies a unique opportunity to grow their brands internationally. Utah companies are invited to the World Trade Center office to learn how they can test Southeast Asia for expansion without large-scale investment. Hear from on-the-ground experts and local tech leaders about building sales channels, finding the right partners, navigating regulations, and overcoming common barriers.

Please RSVP by Monday, March 20. Contact Rayanne Riepl with questions.

Pharma Partnering Summit 2023

May 4 - 5, 2023
San Diego, CA

The Pharma Partnering US Summit 2023 is one of the most prestigious physical events of 2023 on the US West Coast for life sciences professionals.

This platform brings together senior executives from different parts of the world, focused on Licensing, R&D Collaborations, Commercialisation & Distribution deals, Fundraising, Investing, Digital Health Alliances, M&A, Going Public as well as partnering opportunities in the broader aspects.

The agenda is structured for the needs of Pharma & Biotech Senior Executives.

International Trade Administration Resource: Market Intelligence Links by Country/Industry

International market research is key to successful export planning. The International Trade Administration's trade professionals in more than 70 international offices help keep you informed about opportunities in key markets through their Market Intelligence program. Market intelligence is listed by country or by industry. Click below for more information about individual countries.

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March 20, 2023

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