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.

"The BRAINBox TBI test is the first to integrate physiologic and functional testing, an approach that is designed to maximize sensitivity and specificity, and provide objective criteria for the diagnosis and prognosis of acute traumatic encephalopathy, commonly known as concussion," said W. Frank Peacock, MD FACEP, FACC, FESC, the study's Principal Investigator and Professor, Vice Chair for Research, Henry JN Taub Department of Emergency Medicine, Baylor College of Medicine.

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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. 

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.

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.”

October 25th, 2023 – Johnson & Johnson Innovation, in collaboration with Carilion Clinic Innovation, Verge Alliance (with support from City of Roanoke), and Virginia Tech Corporate Research Center (VTCRC), announced today at the Harnessing the Potential of Antibody Drug Conjugates (ADC) in Oncology event at JLABS @ Washington D.C. that Bacchus Therapeutics, Luminary Therapeutics, and QurCan Therapeutics Inc., have been selected as the awardees in the Advancing Oncology InnoVAtion QuickFire Challenge.

The challenge invited innovators from across the globe with an active interest in the Virginia innovation ecosystem to submit potential solutions aiming to transform patient outcomes in oncology in adult populations with potential applications in pediatric oncology. The awardees hope to nurture Virginia’s outstanding innovation ecosystem and spearhead innovative solutions to enhance the quality of life for cancer patients across the globe.

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.

Maryland Venture Fund Authority advises and consults with TEDCO regarding the administration of the InvestMaryland program

COLUMBIA, Md. (October 24, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced the FY24 Maryland Venture Fund Authority (“Authority”) members, including new appointees Vishal Amin, Ricardo Alvarado and Bei Ma.

“TEDCO is excited to welcome these new members to the Maryland Venture Fund Authority,” said Jack Miner, TEDCO’s chief investment officer. “Through their efforts, we know FY24 will be productive, allowing for the continued growth, development and diversification of Maryland’s economic development.”

Authority officers include:

• Grace Garry, Chair
• Renée Winsky, Vice Chair
• Mike Thielke, Secretary

The Authority consists of nine members, seven appointed by Governor Wes Moore with the advice and consent of the Senate, one member appointed by the president of the Senate and one member appointed by the speaker of the House.

The FDA’s Commissioner, Dr. Robert M. Califf, recently visited India and shared his opinion on India’s Unique Opportunity and Important Responsibility as the Pharmacy to the World. The Inaugural 2-day Indo US Bridging RARE Summit was held on Oct 29 and 30, 2023 at George Mason University in Arlington, VA. The organizing committee led by Dr. Harsha Karur Rajasimha at the Indo US Organization for Rare Diseases (IndoUSrare), a US-based nonprofit committed to combating rare diseases, are aiming to catalyze this potential cooperation and harmonization between the FDA and Indian regulators to create a pathway for biopharmaceutical sponsors to start commercially launching orphan therapies in India. The effect can be far reaching, saving or impacting millions of lives. Dr. Peter Marks, Director of Center for Biologics Evaluation Research (CBER), FDA, keynote speaker at the Summit, announced the Creation of Operation Warp Speed for Rare Diseases, a pilot program called Support for Clinical Trials Advancing Rare Disease Therapeutics (START).

(HERNDON, Va.) October 24, 2023: The launch of Operation Warp Speed in 2020 to develop COVID-19 vaccines was a resounding success, developing and making available the vaccines to the general public in record time and saving an estimated 3.2 million lives and $1.15 trillion in the U.S. alone.1 As a result of that achievement, the U.S. Food and Drug Administration (FDA) is launching a pilot program — Support for Clinical Trials Advancing Rare disease Therapeutics (START) — this year to accelerate the pace of development of therapeutics for very small populations with very high medical need. 1 Globally, rare diseases are defined by The World Health Organization (WHO) as a disorder which affects less than 6.5 to 10 people out of 10,000.2 According to a report by RARE-X, there are over 10,897 known rare diseases affecting over 400 million people worldwide. Since the Orphan Drug Act of 1983, the FDA has approved about 1100 orphan drugs to treat about 5-7% of rare diseases. Hence, a majority of rare diseases remain without treatment options. At the recently concluded Indo US Bridging RARE Summit 2023, Dr. Peter Marks, director at the FDA’s Center for Biologics Evaluation and Research (CBER), spoke about the START program, the India opportunity, and stated, “We have fifteen FDA approved gene therapies till date. We are very committed to working with the rare disease communities for gene therapies and with our colleagues globally. India is an incredible opportunity in terms of capacity and capability. By leveraging them and working together, we can achieve some wonderful things for people with rare diseases.”