News Archive

BALTIMORE, Feb. 20, 2025 (GLOBE NEWSWIRE) — Elixirgen Therapeutics, Inc., a clinical-stage biotechnology company focused on treating rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to EXG-34217, a gene therapy for treatment of Telomere Biology Disorders (TBDs). EXG-34217 is currently being studied in an ongoing Phase 1/2 trial (NCT04211714) for the treatment of patients with TBDs with bone marrow failure. Enrollment is currently open for participants aged 12 and older, regardless of gender or ethnicity.

The FDA recently granted EXG-34217 Rare Pediatric Disease Designation (RPDD) and Regenerative Medicine Advanced Therapy (RMAT) Designation.

BALTIMORE, MD (January 24, 2025) – Governor Wes Moore today announced the appointment of Harry Coker, Jr. as secretary of the Maryland Department of Commerce. Coker will assume the post as acting secretary on Feb. 5 and his appointment is pending confirmation by the Maryland State Senate during the 2025 Legislative Session. Coker will succeed Secretary Kevin Anderson, who will transition to a new role as senior advisor to the governor for economic development.

“At the heart of our economic growth agenda is a commitment to investing in industries of the future—from cyber to quantum. Harry Coker understands that mission and brings a wealth of experience working on the leading edge of the very sectors Maryland stands to win,” said Gov. Moore. “Our entire administration is grateful for Kevin Anderson’s distinguished service and we look forward to this new chapter at the Maryland Department of Commerce under Harry Coker’s leadership.”

Maryland-founded healthcare company continues to lead in medical diagnostic innovation

COLUMBIA, Md., (February 18, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 dual investment in Novel Microdevices, a company aiming to provide quality point-of-care diagnostics. This investment included $250,000 from the Venture Funds and $250,000 from the Inclusion Fund, a fund under the Social Impact Funds umbrella.

“Our company has made incredible progress during the past year since TEDCO chose to invest in our vision,” said Andrea Pais, CEO of Novel Microdevices “This investment will play an important role in ensuring our product, NovelDx, makes an impact in the healthcare industry.”

Novel Microdevices, located in Baltimore, Md., is a medical device company developing a solution for clinical diagnostics. Through research and development efforts, the company founded the NovelDx device – a solution that seeks to challenge the point-of-care antigen and molecular testing market by providing lab-level PCR tests in under 15 minutes.

Collaboration Aims to Develop First Intranasal Therapy for Mild Traumatic Brain Injury Aka Concussion, Establishing a Comprehensive Test-to-Treat Platform

SARASOTA, Fla. and RICHMOND, Va., Feb. 11, 2025 (GLOBE NEWSWIRE) — Oragenics, Inc. (NYSE American: OGEN), a biotechnology company advancing innovative treatments for concussion and brain-related health conditions, today announced a strategic partnership with BRAINBox Solutions, a leader in multi-modality diagnostics for traumatic brain injury (TBI). This collaboration seeks to develop the first intranasal therapy for mild traumatic brain injury (mTBI) aka concussion, creating a comprehensive trigger-to-treat platform by combining BRAINBox’s advanced multimarker/ multimodality diagnostic capabilities with Oragenics’ novel therapeutic development.

WASHINGTON, DC / BERN, SWITZERLAND – Children’s National Hospital and Compremium AG entered into a strategic partnership to develop and commercialize cutting-edge medical technologies for the pediatric population. This partnership will bring Compremium’s non-invasive and AI-enhanced technology to the forefront of pediatric healthcare.
Diagnosing pressure-related conditions without complicated, invasive procedures has long been a challenge in the medical community. Compremium’s technology aims to transform the diagnosis of pressure physiologies, including venous pressure, intracranial pressure, and tissue pressure conditions with their non-invasive, point of care solution. Through this strategic collaboration, Children’s National will serve as the Pediatric Innovation Hub for Compremium, leading clinical studies, research projects, and commercialization efforts focused on non-invasive pressure monitoring and other breakthrough technologies.

GAITHERSBURG, Md.–(BUSINESS WIRE)–GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced ultraRapid Whole Genome Sequencing, offering accelerated and comprehensive genomic insights for neonatal and pediatric patients in the NICU and PICU in as soon as 2 days.

BALTIMORE, Feb. 13, 2025 (GLOBE NEWSWIRE) — Elixirgen Therapeutics, Inc., a clinical-stage biotechnology company focused on treating rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to EXG-34217, a gene therapy for treatment of Telomere Biology Disorders (TBDs). EXG-34217 is currently being studied in an ongoing Phase 1/2 trial (NCT04211714) for the treatment of patients with TBDs with bone marrow failure. Enrollment is currently open for participants aged 12 and older, regardless of gender or ethnicity.

By Conor Gowder & Mark Skinner

The Feb. 7, 2025, memo from the NIH Office of the Director (NOT-OD-25-068), now on hold because of two federal judge actions, announced the implementation of a flat 15% Facilities and Administrative fee (F&A) “across all NIH grants.” While the historic average F&A, or indirect cost rate, paid for by NIH is between 27 and 28%, the memo stated, the agency has previously allowed private small businesses without a negotiated F&A rate to charge up to 40% on their SBIR/STTR awards without further justification, drastically lowering their administrative burdens. Thus, a flat 15% fee on F&A if ever implemented would likely lead to some hardship for the small businesses.