News

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.

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.

As part of the President’s Investing in America agenda, the U.S. Department of Commerce identified regional centers primed for technological innovation and job creation.

WASHINGTON, DC — The Biden-Harris administration, through the U.S. Department of Commerce’s Economic Development Administration (EDA), today announced the designation of 31 Tech Hubs in regions across the country. This is the first phase of the new Tech Hubs program, which is an economic development initiative designed to drive regional innovation and job creation by strengthening a region’s capacity to manufacture, commercialize, and deploy technology that will advance American competitiveness.  The program invests directly in burgeoning, high-potential U.S. regions and aims to transform them into globally competitive innovation centers.

FDA Clears Rise Therapeutics’ IND Application to Initiate a Phase 1 Clinical Study of Its Novel Oral Immunotherapy for the Treatment of Rheumatoid Arthritis

ROCKVILLE, Md., Oct. 19, 2023 /PRNewswire/ — Rise Therapeutics a biotechnology company engaged in developing novel oral immunotherapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application to proceed with a rheumatoid arthritis Phase 1 clinical trial for its program candidate, R-2487. This is Rise Therapeutics’ second clinical program developed using synthetic biology and its proprietary oral biologics delivery platform.

Immunomic Therapeutics Reports Positive Results from Its Phase 1 Clinical Trial of ITI-3000 in Patients Diagnosed with Merkel Cell Carcinoma

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc. (ITI), a privately-held clinical-stage biotechnology company pioneering the development of LAMP-mediated nucleic acid-based immunotherapy, today announced safety and tolerability results from its phase 1 clinical trial evaluating ITI-3000, a plasmid DNA (pDNA) vaccine, targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV). ITI-3000 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in November 2022.