BioHealth Innovation Weekly for October 31, 2023

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October 31, 2023

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BioHealth Innovation Inc. (BHI) Announces the Addition of New Technical Writer and Program Manager, Jon Nelson

ROCKVILLE, MARYLAND, October 30, 2023 – BioHealth Innovation Inc. (BHI) proudly welcomes Jon Nelson to its innovative team. Jon joins BHI as a Technical Writer and Program Manager, bringing an impressive nine years of research experience within the biological sciences, further enhancing BHI’s commitment to advancing healthcare technologies.

Jon’s journey in biological sciences began with the pursuit of his master’s degree in biology at the University of North Carolina at Greensboro. During this time, he worked with bioinformatics to predict epigenetic drug efficacy and leverage cutting-edge technology for groundbreaking solutions.

“We are excited to have Jon Nelson join our team. His extensive research experience and innovative mindset align perfectly with BHI’s mission to drive innovation and transformative healthcare solutions,” said Monique Bennett, BHI Life Science Business Strategist.

BRAINBox Solutions Announces Initial Series B Investments to Support U.S. Regulatory Clearance, Initial Commercialization of BRAINBox TBI Concussion Diagnostic/Prognostic Test

RICHMOND, Va., Oct. 30, 2023 /PRNewswire/ -- BRAINBox Solutions today announced initial investments into the company's Series B financing to support U.S. regulatory clearance and initial commercialization of its BRAINBox TBI concussion diagnostic/prognostic test in adults and completion of a clinical study in pediatric patients. Genoa Ventures is leading the financing, which includes other current and new investors.

"We have made significant clinical and pre-commercial progress in developing the BRAINBox TBI test," said Donna Edmonds, BRAINBox Solutions' CEO. "We are working with selected platform partners as we determine the fastest path to market for use in both point-of-care and emergency department settings." She noted that in addition to the adult population, the company is developing BRAINBox TBI tests for pediatric patients, and, through a National Institutes of Health grant, for geriatric patients.

United Therapeutics to Acquire Miromatrix Medical

October 30, 2023 06:00 AM Eastern Daylight Time - SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. & EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR) and Miromatrix Medical Inc. (Nasdaq: MIRO) announced today a definitive agreement for United Therapeutics to acquire Miromatrix.

Miromatrix is a life sciences company focused on the development of bioengineered organs composed of human cells. United Therapeutics is a biotechnology company with six FDA-approved therapies to address rare, life-threatening conditions, and a pipeline that includes four ongoing registration-phase studies. The acquisition of Miromatrix will expand United Therapeutics’ existing complementary platform of organ manufacturing programs, which include ex-vivo lung perfusion, xenotransplantation, 3-D bioprinting, and regenerative medicine approaches with the objective of creating an unlimited supply of tolerable, transplantable organs.

FDA approves muscular dystrophy drug built on Children’s National research

WASHINGTON, D.C., Oct. 27, 2023 (GLOBE NEWSWIRE) -- Boys with Duchenne muscular dystrophy (DMD) have a clinically proven, new treatment option with the Food and Drug Administration’s approval Thursday of vamorolone, a steroidal-type, anti-inflammatory drug developed based on research performed at Children’s National Hospital.

Created by ReveraGen BioPharma Inc., vamorolone has a molecular structure similar to traditional corticosteroids, which are currently used to treat DMD. Yet its structure was found to be chemically different enough to reduce unwanted side effects, including brittle bones and reduced stature. Nearly two decades ago, ReveraGen leaders – President and CEO Eric Hoffman, Ph.D., and Vice President for Research Kanneboyina Nagaraju, D.V.M., Ph.D. – launched research efforts into the drug when they led the Center for Genetic Medicine Research at Children’s National. They worked with then-Chief Academic Officer Mark Batshaw, M.D., on the new clinical option.

Gaithersburg's Georgiamune and Verily Announce Strategic Partnership to Advance Novel Cancer Treatment

GAITHERSBURG, Md. & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Georgiamune, a privately held, clinical stage biotechnology company, and Verily, an Alphabet precision health technology company, today announced a strategic partnership to advance novel therapeutics for patients with cancer.

The partnership will focus on deploying Verily’s advanced molecular and real-world evidence solutions with the intention to support the development of Georgiamune’s therapeutic candidates through the discovery of predictive and outcome biomarkers. The two companies will also focus on driving more efficient clinical development by incorporating clinical trial data and longitudinal real-world data sources. The collaboration innovates how clinical trials are currently conducted by bringing together different data modalities to identify the patient populations most likely to benefit from Georgiamune’s novel therapy and by providing a more holistic analysis of how participants are responding to the therapy over time.

Altimmune Granted Fast Track Designation by FDA for Pemvidutide for the Treatment of Non-Alcoholic Steatohepatitis (NASH)

GAITHERSBURG, Md., Oct. 26, 2023 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical program investigating pemvidutide for the treatment of NASH.

NASH is a serious, potentially life-threatening condition that is a leading cause of liver failure and liver transplantation globally. NASH is a growing public health concern, and there are currently no approved treatments. The Fast Track designation is designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions and address unmet medical needs.

“The FDA’s decision was informed by the results of Altimmune’s studies including its Phase 1b randomized, placebo-controlled study of pemvidutide in subjects with non-alcoholic fatty liver disease (NAFLD), which showed class-leading relative reductions in liver fat and non-invasive markers of hepatic inflammation and a favorable safety and tolerability profile,” said Vipin K. Garg, Ph.D., President and CEO of Altimmune. “The Fast Track designation reflects Altimmune’s commitment to patients with NASH and efforts to find safe and effective treatments for this condition.”

Centers for Medicare & Medicaid Services Awards MITRE New Five-Year Contract to Continue Operating Health R&D Center

MCLEAN, Va. & BEDFORD, Mass.--(BUSINESS WIRE)--MITRE announced a new five-year contract with the Centers for Medicare & Medicaid Services (CMS) to operate the CMS Alliance to Modernize Healthcare, a federally funded research and development center, more commonly known as the Health FFRDC.

Established in 2012, the Health FFRDC serves the public interest by tackling complex, cross-cutting challenges affecting health and well-being. As the Health FFRDC operator, MITRE serves as an objective advisor to CMS, the Centers for Disease Control and Prevention, Food and Drug Administration, National Institutes of Health, Health Resources and Services Administration, Administration for Children and Families, and all the operating divisions across HHS, as well as other governmental organizations with health missions.

Unveiling the Future of Viral Safety: The 2024 PDA Virus Conference in Amsterdam

Dive into the world of viral safety with the upcoming 2024 PDA Virus Conference. Set against the picturesque backdrop of Amsterdam, this event promises to be a melting pot of knowledge, innovation, and networking.

📅 Dates to Remember:

Conference: Jun 26 - Jun 27, 2024
Abstract Submission Deadline: November 30, 2023

📍 Location: Amsterdam Marriott Hotel, Stadhouderskade 12, Amsterdam, The Netherlands. Nestled amidst iconic attractions, the hotel offers a blend of luxury and convenience.

🔍 Theme: "Viral Safety Reloaded - the Finalized ICH Q5A (R2)"

🌟 Highlights:

A unique opportunity to attend two conferences in a week, with the Advanced Therapy Medicinal Product Conference preceding this event.
Engage with a diverse Scientific Program Planning Committee, featuring stalwarts from ViruSure, Eli Lilly, Merck KGaA, U.S. FDA, and more.
Submit your abstracts! Remember, they should be non-commercial and focus on breakthroughs in Virus Safety.