By Alex Philippidis - February 26, 2025 - The FDA has granted Priority Review to Precigen’s Biologics License Application (BLA) for its lead candidate PRGN-2012, the company said—a step forward for a gene therapy that, if approved, would be the first treatment indicated for adults with the rare disease of recurrent respiratory papillomatosis (RRP).

The FDA also set an August 27 target date for deciding on Precigen’s BLA under the Prescription Drug User Fee Act (PDUFA). PRGN-2012—which Precigen has begun to call by its generic name of zopapogene imadenovec—is a gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11.

Protenus, a leading healthcare compliance analytics platform that serves over 200 healthcare organizations, was acquired in January 2025 by Bluesight, a prominent provider of inventory management, procurement, and compliance solutions for health systems and hospital pharmacies. This acquisition marks a significant milestone in Protenus’ journey, which began nearly 12 years ago at Johns Hopkins University.

The story of Protenus began with the initiation of DreamIt Health Baltimore (BHI was also a DreamIt Partner), a former accelerator the university helped sponsor, which was organized by its parent company, DreamIt Ventures. The program received about 100 applications, and 10 teams were selected for the first cohort. Among them were medical students Nick Culbertson and Robert Lord. Initially, they set out to innovate in the digital health space without a specific product in mind however, their journey changed after they connected with Peter Greene, the Chief Medical Information Officer of Johns Hopkins Medicine.

BALTIMORE--(BUSINESS WIRE)--TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, today announced the initiation of a fully funded Phase 2b clinical trial evaluating oral TNF-alpha (TNF-α) inhibitor drug candidate isomyosamine as a treatment for chronic inflammation associated with muscle loss (frailty or sarcopenia) in patients who have undergone hip or femur fracture repair surgery.

COLUMBIA, Md., (February 25, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Venture Funds investment in Pathotrak. TEDCO’s evergreen Venture Funds are dedicated to funding and growing the next generation of early-stage technology and life sciences businesses in Maryland. Through this fund, companies are offered an experienced team that is focused on supporting the entrepreneurial journey.

“Ensuring food safety is a growing challenge, and current testing methods are often slow and costly for producers,” said Javier Atencia, CEO of Pathotrak. “With TEDCO’s continued support, we are advancing our technology in an effort to shorten the time required for pathogen detection, empowering manufacturers with what we hope are faster, more reliable solutions.”

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.

On April 1, 2025, Georgetown University’s Office of Technology Commercialization, in partnership with the Georgetown Entrepreneurship Initiative, will host the first-ever Georgetown Research and Innovation Showcase. This half-day event will bring together researchers, entrepreneurs, investors, and industry leaders to highlight groundbreaking discoveries and explore commercialization opportunities.

Attendees can expect engaging research presentations, an industry panel discussion, and a fast-paced Venture Fair, where selected faculty, student, and alumni-led startups will pitch their disruptive technologies to an audience of venture capitalists, angel investors, and corporate innovation teams.

The event will culminate in a networking reception, offering a unique opportunity for collaboration and funding discussions between the Georgetown community and key industry players. Whether you’re an innovator, investor, or looking to connect with cutting-edge ventures, this is an event you won’t want to miss.

📅 Date: April 1, 2025
🕜 Time: 1:30 PM – 6:30 PM ET
📍 Location: Georgetown University

Don’t miss your chance to be part of this exciting showcase of innovation and entrepreneurship!

https://otc.georgetown.edu/newsevents/research-and-innovation-showcase-2025/

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.

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.

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.

The Deloitte AI Institute has launched a new video series, You, Me, and Three: GenAI Questions, featuring industry leaders discussing the rapid transformation of federal health through generative AI and automation. BHI Board of Directors Member Juergen Klenk, Principal at Deloitte Consulting LLP, joined Beena Ammanath in this series to explore how organizations can cut through the AI hype and establish trust around AI. Watch the full series to gain insights from cross-industry experts on the future of AI in healthcare.

https://youtu.be/dNFsBSjBCFc

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.

The sixth cohort will undergo the first iteration of the program’s new structure

COLUMBIA, Md., (February 13, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced the sixth SBIR/STTR Proposal Lab cohort that will consist of 28 companies. Through this program, companies will learn about foundational skills in business planning, commercialization and proposal writing.

“TEDCO is committed to uplifting Maryland’s entire ecosystem; one way we do that is by providing opportunities to engage with experts and receive comprehensive training materials,” TEDCO CEO Troy LeMaile-Stovall explained. “The success of this program has prompted its growth into two parts – one focusing on foundational skills and the second focusing on opportunities to enhance quality and submission readiness of the proposals.”

TG Therapeutics to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to support the development and commercialization of azer-cel, its allogeneic CD19 CAR T cell therapy program, for the treatment of autoimmune diseases

ROCKVILLE, Md., Feb. 12, 2025 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics, today announced they are entering into a strategic platform license (SPL) with TG Therapeutics, a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases.

Under the terms of the agreement, TG Therapeutics obtains non-exclusive research, clinical and commercial rights to use MaxCyte’s Flow Electroporation^® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive annual licensing fees and program-related revenue.

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.

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.

As we celebrate Women in Science Day and Women’s History Month, we are proud to spotlight the women of Volition.  From driving groundbreaking innovation to shaping strategic direction, our team do a fantastic job and we’d like to kick off the month of celebrations by featuring our female Directors on our Board.

The women on our Board of Directors are at the forefront of advancing science, fostering inclusivity, and paving the way for the future of health and medicine.

Dr. Ethel Rubin, who joined our Board in September 2024, has dedicated over 20 years to the life sciences sector, driving innovation and commercialisation strategies. Her advice to young women entering science? “Let your intellectual curiosity guide you.” She encourages future scientists to be true to themselves in choosing their career paths—whether they’re solving real-world problems or diving deep into basic biology. Ethel also highlights the importance of perseverance:

By Brian Darmody: While the Maryland economy is facing budget uncertainties, the state can help surmount these challenges by growing private growth industries, converting research into jobs, connecting the region, and attracting federal funding from those few federal budgets (defense and economic competitiveness) that are likely to grow.

Here’s how:

Winning the technology race with China will be a bipartisan effort in Congress and with the White House and state of Maryland has a role to play. The Department of Defense (DOD) R&D budget is expected to grow, including its University Affiliated Research Centers (UARCs) that ensure essential engineering and technology capability are maintained.

New Study Highlights Importance of Measuring Well-Being in Mental Health Research

WASHINGTON (February 10, 2025) – A new study published in Nature Mental Health underscores the critical role of assessing well-being in clinical research and treatment. 

Led by Fallon Goodman of the George Washington University, the study highlights how well-being, beyond the absence of mental illness, is essential for long-term health outcomes, including resilience, recovery, and overall quality of life.

Despite its importance, well-being is often overlooked in mental health research. The study identifies challenges in measuring well-being, such as inconsistencies in assessment methods, and offers recommendations to improve research approaches. By incorporating well-being metrics into clinical trials and treatment evaluations, researchers and clinicians can gain a more comprehensive understanding of mental health and enhance patient outcomes.

What does it take to establish Maryland as a powerhouse for biotech commercialization? In this episode of BioTalk with Rich Bendis, Dr. Deborah Hemingway, Founder and Managing Partner of Ecphora Capital, shares her insights on the current investment landscape in the BioHealth Capital Region. She discusses the strategic advantages that make Maryland uniquely positioned for success, the critical gaps that must be addressed, and how state and local governments can provide essential support through tax credits, grants, and economic incentives.

Dr. Hemingway also highlights Ecphora Capital’s impact, having deployed $15 million in the last two years, and reveals the firm’s strategy for future investments, including SPVs and a dedicated fund. With deep experience in medtech commercialization, strategic partnerships, and early-stage investing, she offers valuable perspectives on where the industry is headed in 2025 and how companies can thrive in an evolving biotech ecosystem.

Listen via your favorite podcast platform:
Apple: https://apple.co/40QvxJg
Spotify: https://spoti.fi/3WWEvTZ
Amazon Music: https://amzn.to/3QbxZoH
YouTube Music: https://bit.ly/40T7xVF
TuneIn: https://bit.ly/42LITcb

Tune in for a compelling conversation on innovation, investment, and the future of biotech in the BioHealth Capital Region.

GERMANTOWN, Md., Feb. 06, 2025 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced it has filed for CE Mark registration for the Eversense^® 365 CGM system.

Eversense 365 is the world’s first and only one year CGM, which was approved by the United States (US) Food and Drug Administration in September of 2024 and launched across the country in October of the same year.

Newswise — Children’s National Hospital and Virginia Tech are expanding their research partnership, building on a successful collaboration established in 2019. This partnership will advance pediatric health through innovative discoveries and therapies with an initial focus on pediatric cancers, including brain tumors.

The partnership brings together Children’s National, ranked among the nation’s top pediatric hospitals by U.S. News & World Report, and Virginia Tech, a leading academic research institution. Together, they aim to deliver transformative advancements to enhance outcomes for children facing devastating diagnoses.

“Over the years, our partnership with Virginia Tech has demonstrated the power of combining top-tier research expertise with a shared commitment to improving pediatric health,” said Catherine Bollard, senior vice president and chief research officer and director of the Center for Cancer and Immunology Research. “This expansion underscores our belief that by working together, we can accelerate discoveries and develop life-changing therapies for children with cancer and other rare diseases.”

In an interview with ACT Associate Editor Don Tracy, Peter Ronco, CEO, Emmes, discusses the "Choosing the Right Allies: Ensuring Clinical Trial Success for Small Biopharma" session.
ACT: Today, you were a part of the Choosing the Right Allies: Ensuring Clinical Trial Success for Small Biopharma session. Can you provide a brief synopsis of what the session entailed?

Ronco: When we kicked off this morning, Andy Lee spoke in the main session about how he has leveraged Merck and their clinical trial development group to execute a portfolio of work. That model works well for Merck—they have the money and resources. However, many mid-sized and small biotechs don’t have that level of funding and can’t afford to hire thousands of CROs.

ROCKVILLE, Md., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that the U.S. Food and Drug Administration (FDA) approved ONAPGO (apomorphine hydrochloride) injection, formerly known as SPN-830, as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). Supernus will make ONAPGO available in the second quarter of 2025 with a support team of experts, including a robust nurse education program, and access support at launch.

Over 100,000 patients in the United States have IPF, with only two approved therapies available that only slow the course of disease progression

Top line data expected in the first half of 2026

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced full enrollment of the TETON 1 study evaluating the use of Tyvaso® (treprostinil) inhalation solution (nebulized Tyvaso) for the treatment of idiopathic pulmonary fibrosis (IPF).

WASHINGTON and SAN DIEGO, Feb. 3, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) and AnaptysBio, Inc. (Anaptys) (Nasdaq: ANAB) today announced an exclusive, global license agreement for the development and commercialization of imsidolimab (IL-36R antagonist mAb), which has successfully completed two registration-enabling global Phase 3 trials, GEMINI-1 and GEMINI-2, evaluating the safety and efficacy of imsidolimab in patients with Generalized Pustular Psoriasis (GPP).

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) to initiate a clinical study of the company’s investigational UKidney™ derived from a 10 gene-edited source pig. The study will enroll an initial cohort of six end-stage renal disease (ESRD) patients, expanding to up to 50 participants, and is intended to support a Biologics License Application (BLA) with the FDA.

MONTGOMERY COUNTY, Md. — Businesses in Maryland’s Montgomery County experienced a surge in investment funding in 2024. Mergers and acquisitions, venture capital and private funding deals totaled $2.9 billion, a 36% increase over 2023’s total of $2.2b. Spanning 106 deals across 96 companies, this surge in mergers and acquisitions, venture capital, and private investment reflects Montgomery County’s continued prominence as a regional economic leader. 

Diverse Industries Driving Growth 

Read more ...

ROCKVILLE, Md., Jan. 30, 2025 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing solutions to advance the discovery, development and commercialization of next-generation cell therapeutics announced today the acquisition of SeQure Dx, a market leader of on-target and off-target editing assessment services for cell and gene therapies.

This strategic acquisition strengthens MaxCyte’s ability to serve ex vivo and in vivo cell and gene therapy (CGT) developers with an innovative suite of tools and services spanning early R&D through clinical development and commercialization. By integrating SeQure Dx into MaxCyte, Maxcyte will expand its service offerings and leverage its commercial and field application scientist teams to work with developers earlier in their research processes. SeQure Dx is revenue generating and expected to be accretive to MaxCyte’s revenue growth.

For the second year in a row, the BioHealth Capital Region (BHCR) has been ranked as a Top 3 BioCluster Hub by Genetic Engineering and Biotechnology News (GEN). Montgomery County, Maryland, located in the heart of the BHCR, offers unparalleled assets, including proximity to the FDA and NIH, making it a premier destination for biohealth innovation. Adding to its already successful programs, Montgomery County is launching new initiatives to further support biotech success in 2025 and beyond.

Existing programs continue to provide strong support for growing companies. The Executive-in-Residence Program connects entrepreneurs in the County with experienced mentors who guide commercialization strategies and accelerate growth. The SBIR Matching Program helps companies amplify their non-dilutive funding by providing additional resources to build on their Small Business Innovation Research (SBIR) awards. Additionally, the Investor Tax Credit incentivizes private investment in Maryland’s innovative companies, making it more attractive for investors to support local startups.

Building on these efforts, Montgomery County is introducing the Technology Innovation Fund and the Founders Fund, which will provide grants of up to $200,000 and $100,000, respectively. These programs are designed to support commercialization milestones for companies in sectors such as healthtech, life sciences, artificial intelligence, and quantum technologies. Additional incentives like the expanded MOVE program and JOBS grants will make it even easier for companies to establish and grow their presence in the county. Partnerships with the Henry Jackson Foundation and BioHub will further enhance the local ecosystem by creating new opportunities and resources for the biotech sector. Applications for the Technology Innovation and Founders Funds are due by January 31, 2025.

ETC Baltimore, dedicated to elevating Baltimore as a national leader in tech startups, announces the opening of its inaugural ETC Venture Hub at Connect Labs Baltimore in the newly constructed 4MLK Building in the University of Maryland BioPark. This milestone marks a significant step in Baltimore’s efforts to strengthen its ecosystem for life science startups and attract high-potential companies to the city.

The ETC Venture Hub at Connect Labs Baltimore is a dedicated space designed to provide early-stage life science companies with the technology, capital, talent and resources needed to successfully grow and scale. Offering desk space, expert support, and a collaborative community, the hub serves as a launchpad for startups. This is part of ETC’s broader strategy to establish multiple footprints throughout the city. By expanding its reach, ETC aims to create a more inclusive and robust entrepreneurial ecosystem, ensuring innovators in all areas of Baltimore have access to the tools and support they need to thrive.