News

By Benjamin Mueller -The Trump administration stormed into office, loudly firing workers and closing diversity programs. But behind the scenes, it has also brought biomedical research to the brink of crisis by holding up much of the $47 billion the United States spends on the field every year.

The world’s leading medical labs can be found in the United States, and they rely on grants from the National Institutes of Health. The agency has stopped vetting future studies on cancer, Alzheimer’s, heart disease and other ailments. Trump aides have said they just need time to review spending their predecessors had promised, but it’s unclear what they’re looking for at the N.I.H. or when scholars can expect to start receiving money again.

In today’s newsletter, I’ll walk you through what happened — and why it matters.

ANNAPOLIS, Md., Feb. 19, 2025 /PRNewswire/ — Alphyn, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^®, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis. Zabalafin Hydrogel is unique in its ability to directly treat all the problems of AD, specifically directly treating the bacterial cause of AD, directly treating AD’s pruritus (itch), and directly treating the immuno-inflammatory cause of the disease.

VIENNA, Va.–(BUSINESS WIRE)–CEL-SCI Corporation (NYSE American: CVM) today announced it is in the final stages for the launch of its 212-patient Confirmatory Registration Study for Multikine* (Leukocyte Interleukin, Injection) in newly diagnosed locally advanced head and neck cancer patients. This final Registration Study is specifically designed to confirm the statistically significant efficacy and safety results from CEL-SCI’s previously completed randomized controlled Phase 3 trial.

GERMANTOWN, Md.–(BUSINESS WIRE)–Amarex today announced its work on behalf of Britecyte has resulted in a “safe to proceed” status by the United States Food and Drug Administration (FDA) for its Adipose Tissue Allograft (BRC-OA).

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.