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ReGelTec Announces First Patient Treated in U.S. IDE Clinical Trial for HYDRAFIL System to Treat Chronic Low Back Pain

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ReGelTec250BALTIMORE–(BUSINESS WIRE)–ReGelTec Inc., a company developing a percutaneous hydrogel implant for the treatment of chronic low back pain caused by degenerative disc disease, announced it has treated the first patient in its HYDRAFIL-D FDA investigational device exemption (IDE) clinical trial for its HYDRAFIL® System for disc augmentation. The patient was enrolled by Kas Amirdelfan, M.D., an interventional pain physician and founding member of Boomerang Healthcare, Inc. in Walnut Creek, Calif. The HYDRAFIL System is an outpatient procedure offering interventional pain physicians and patients a new treatment designed to reduce pain and improve daily function without the need for an invasive surgery.

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uBriGene Launches Clinical iPSC Banks to Accelerate Regenerative Medicine and Cell Therapy Development

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brigeoe250ROCKVILLE, MD / ACCESS Newswire / June 16, 2025 / uBriGene Biosciences, a leading cell and gene therapy CDMO, is proud to announce the launch of its fully characterized, ready-to-use induced pluripotent stem cell (iPSC) banks. Developed using uBriGene’s proprietary RNA-LNP reprogramming technology, these iPSC banks are now available to support research, translational development, and clinical applications worldwide.

uBriGene’s iPSC seed banks and master cell banks (MCBs) are generated in GMP-compliant cleanrooms using healthy donor fibroblasts sourced from the USA in full compliance with FDA regulations. Reprogrammed with a non-integrating mRNA-LNP kit, the iPSCs are free of genomic footprint and residual RNA.

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NextCure and Simcere Zaiming Partner to Develop New Targeted Cancer Therapy

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NextCureSimcereBELTSVILLE, Md. and SHANGHAI, June 16, 2025 (GLOBE NEWSWIRE) — NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, and Simcere Zaiming, an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced a strategic partnership to develop SIM0505, a novel antibody-drug conjugate (ADC) targeting CDH6 (cadherin-6 or K-cadherin) for the treatment of solid tumors. SIM0505 is currently in Phase 1 clinical testing in China; NextCure expects to begin clinical testing in the U.S. in the third quarter of 2025.

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TEDCO Invests in Astek Diagnostics

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TedcoAstekCOLUMBIA, Md., (June 17, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 dual investment in Astek Diagnostics, a biomedical company. This investment came from both the Pre-Seed Builder Fund, part of TEDCO’s Social Impact Funds, which supports Maryland’s underrepresented startup communities, and the Venture Funds, dedicated to funding and growing the next generation of early-stage businesses in the state.

Astek Diagnostics, based in Baltimore, Md., is a medical technology company working to transform infectious disease management through its Jiddu™ Platform—a diagnostic system that aims to deliver antibiotic susceptibility results in under one hour. Designed to support faster, more targeted treatment decisions, the platform addresses infections such as urinary tract infections (UTIs), sepsis and wound infections. Unlike traditional culture-based methods, which take 48 to 72 hours, Astek’s phenotypic approach aims to provide results at the point of care, hopefully reducing wait times without compromising precision.

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Registration Now Open for the 11th Annual BioHealth Capital Region Week

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bhcrWEEK250BioHealth Capital Region Week returns for its 11th year, and registration is now officially open. Scheduled for September 23–25, 2025, this annual gathering will once again take place at US Pharmacopeia (USP) in Rockville, Maryland, bringing together leaders from across the biohealth ecosystem for three days of innovation, connection, and forward-thinking dialogue.

This year’s theme—“Where Human and Artificial Intelligence Converge in the BioHealth Industry”—will guide Forum discussions as experts from across industry, government, and academia explore how AI is reshaping drug development, diagnostics, health data, and the future of care delivery.

Sponsorship opportunities are still available at multiple levels, including standard, lunch, networking reception, VIP dinner, and display table options. Sponsors receive prominent visibility throughout the event and exclusive access to the region’s top biohealth leaders.

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TEDCO Invests in Higher Medicine

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TedcoHigher250Maryland business researching treatment options for a debilitating illness

COLUMBIA, Md., (June 16, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $100,000 Pre-Seed Builder Fund investment in Higher Medicine. The Pre-Seed Builder Fund is housed under the Social Impact Funds, an umbrella of investment opportunities that seek to provide eligible entrepreneurs with access to support and capital.

“Kabuki syndrome is a rare genetic disorder in children that results in developmental delays, distinct facial features, and various medical complications throughout life,” said Leo Kim, Ph.D, founder and CEO of Higher Medicine. “We are looking to give hope to those impacted by developing a treatment that addresses the root causes, rather than symptomatic relief only. With TEDCO’s investment, we are excited to continue forward.”

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Supernus Pharmaceuticals to Acquire Sage Therapeutics, Strengthening its Neuropsychiatry Product Portfolio

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SupernusSage250ROCKVILLE, Md. and CAMBRIDGE, Mass., June 16, 2025 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) and Sage Therapeutics, Inc. (Nasdaq: SAGE), today announced a definitive agreement for Supernus to acquire Sage through a tender offer for $8.50 per share in cash (or an aggregate of approximately $561 million), payable at closing, plus one non-tradable contingent value right (CVR) collectively worth up to $3.50 per share in cash (or an aggregate of approximately $234 million), for total consideration of $12.00 per share in cash (or an aggregate of up to approximately $795 million). The CVR is payable upon achieving certain net sales and commercial milestones. The transaction is expected to close in the third quarter of 2025.

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Rich and Amy Hay Tall

Inside CTMC: Amy Hay on Reshaping Cell and Gene Therapy on BioTalk

By BioTalk with Rich Bendis Podcast, News

Rich and Amy Hay TallIn this episode of BioTalk, Amy C. Hay, Chief Business and Strategy Officer at the Cell Therapy Manufacturing Center (CTMC), joins the conversation to explore the evolving landscape of cell and gene therapy. Amy shares insights from her extensive career in oncology care and innovation, highlighting the role CTMC—a joint venture between National Resilience and MD Anderson Cancer Center—is playing in accelerating the transition from discovery to commercialization. She discusses the current state of the industry, what disruption really means in this context, and how new business models can drive stability and impact for early-stage biotech companies. Amy also offers her perspective on how manufacturing must evolve to meet clinical demand, and how CTMC is positioned to lead in this next era of therapeutic development.

Listen now via your favorite podcast platform:
Apple: https://apple.co/44dfCYa
Spotify: https://spoti.fi/45SJ3Qv
iHeart: https://ihr.fm/4k7Ck9b
YouTube: https://bit.ly/4jYZ23e
Amazon: https://amzn.to/4k7CoFX
TuneIn: https://bit.ly/3HyBF2X 

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AllSci Wins Grant to Expand AI Platform for Pharma and Biotech R&D: Accelerating Hypothesis-Driven Discovery

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allsci LogoNORTH BETHESDA, Md., June 11, 2025 /PRNewswire/ — AllSci, a pioneer in AI-driven tools for scientific research, has been awarded a grant from Montgomery County, Maryland’s Technology Innovation Fund – accelerating its mission of making science more accessible, connected, and collaborative. The grant supports AllSci’s continued development of its AI-powered research platform, empowering scientists at every level, from students to senior researchers, to formulate hypotheses, validate findings, and contribute to the scientific record, furthering its commitment to transforming the research process into one that is more open, intuitive, and inclusive.

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BrainScope Expands Board and Launches Advanced Deep Learning Platform to Enhance Brain Health Insights

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BrainScope Logo finalBETHESDA, Md.–(BUSINESS WIRE)–BrainScope®, a leader in AI-enabled EEG technology for brain health assessment, today announced the launch of its next-generation deep learning platform. BrainScope developed and has commercialized the first FDA-cleared AI/machine learning medical device in the field of neurology. Building on that foundation in machine learning, BrainScope’s new capabilities enhance its ability to deliver fast, objective, and clinically actionable insights across brain health conditions including concussion, stroke, and early Alzheimer’s detection.

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