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Childrens

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

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ChildrensWASHINGTON, 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. 

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PDA

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

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PDADive 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.
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GeorgiammuneVerily

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

By News

GeorgiammuneVerilyGAITHERSBURG, Md. & SOUTH SAN FRANCISCO, Calif.–()–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.

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Altimmune 250

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

By News

Altimmune 250GAITHERSBURG, 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.”

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CMSMitre

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

By News

CMSMitreMCLEAN, 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.

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MontgomeryCollege250

Montgomery College Faculty Teams Win Three Grants from the National Science Foundation

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MontgomeryCollege250Projects 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.

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TEDCO250

TEDCO announces new appointments for Maryland Venture Fund Authority

By News

TEDCO250Maryland 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.

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GMU

Advancing infectious disease capabilities through biomedical research laboratory core support

By News

George Mason University’s Biomedical Laboratory (BRL) is one of 12 Regional Biocontainment Laboratories (RBLs) established through the National Institute of Allergy and Infectious Diseases. The BRL offers Biosafety Level 3 (BSL-3) facilities that conduct cutting edge pathogen research and serve as resources to rapidly address emerging infectious disease outbreaks. 

Funding will support a number of facility improvements including the implementation of a comprehensive BSL-3 facilities preventative maintenance and upgrade plan to ensure continuity of operations, compliance with federal regulations, and a safe and secure facility. Funding will also enhance safety and quality of BSL-3 laboratory practices and create two new research cores in high containment. 

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techhubs

Biden-Harris Administration Designates 31 Tech Hubs Across America Including Maryland & Virginia

By News

techhubsAs 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.

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TEDCOSISU

TEDCO Announces Investment into Sisu Global Health

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TEDCOSISUMaryland-based, woman-owned biotech company providing hospitals with an autotransfusion device to address the global blood shortage

COLUMBIA, Md. (October 23, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent Inclusion Fund investment of $100,000 into Sisu Global Health, a company that is providing hospitals with an autotransfusion device to replace or augment donor blood in emergency situations.

Sisu Global Health, based in Baltimore, Md., has created an autotransfusion device, Hemafuse; the device provides surgical patients access to fresh, whole blood by capturing it from internal bleeding and giving it back to them immediately in the same surgery. The patented Hemafuse System can operate anywhere there is a surgeon (regardless of infrastructure), making it well suited for military and emerging markets, with applications in the U.S., Sisu Global is bringing Hemafuse to the global market after clinical success in Ghana, Kenya, Tanzania and Ukraine.

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