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Six new products that can be used to detect residual host cell genomic DNA (gDNA)

MANASSAS, Va. and ROCKVILLE, Md., Oct. 30, 2023 /PRNewswire/ — Today, ATCC and U.S. Pharmacopeia (USP), two premier materials management and standards organizations, announced the launch of their first set of joint products to advance the quality control and reduce the risk in the manufacturing of biological therapies and vaccines. This initial set of six products consists of highly characterized and pure genomic DNA (gDNA) from cell lines used in bioproduction that can be used to measure residual host cell DNA in various biotherapeutic products, as required by regulatory authorities. The presence of gDNA is a predominant concern in the development of biological therapies as it can pose a safety risk if it is not removed from the product.

“Developing cutting-edge medicines in the biologics space requires trusted reference materials and standards to ensure quality, consistency and safety,” said Amanda Cowley, General Counsel and SVP Legal, Strategy and People of USP. “With increased demands around the globe for new biological medicines on accelerated timelines, it’s essential that there are products and solutions that can be used to address and advance quality assessment and bring confidence to the development process. By focusing on the detection of gDNA, this first set of ATCC and USP products is significant for the future of biological development as it addresses a common concern when it comes to quality and mitigating risk.”

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.

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.

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.”

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.

Projects will broaden opportunities for traditionally underrepresented students in STEM

In a historic first for Montgomery College (MC), three different teams of faculty and administrators have won grant awards from the National Science Foundation (NSF) totaling over $3.24 million. The grants include EmpowerED: Building the Future Workforce Together, part of the new Enabling Partnerships of Increase Innovation Capacity (EPIIC) program; Beginnings: Democratizing Research and Experiential Education for Microelectronics (DREEM), part of the new Experiential Learning for Emerging and Novel Technologies (ExLENT) program; and AUSEM: Achieving Upward Socio-Economic Mobility, part of the competitive Scholarships in Science, Technology, Engineering and Mathematics program. Each project begins this month, and will expand opportunities for students who have been traditionally underrepresented in STEM fields.