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whiteflint

Maryland Matters: Proposed Metro station development tied to growth of life sciences in Montgomery County

By News, News Archive

whiteflintState and local leaders touted the promise of a proposed mixed-use development to be built over an existing North Bethesda Metro station as a way to grow Montgomery County’s burgeoning life sciences and tech industries.

The facility is still years away from breaking ground. But Montgomery County Executive Marc Elrich said the effort could transform the area into something similar to Kendall Square in Cambridge, Massachusetts, where technology firms are located close to MIT.

“I had been fascinated by the people I had been talking to about life sciences, and talking to me about Kendall Square in Boston, and talking about the urban campus, and talking about the value of collision spaces … rather than everything being done in office parks, where you never talk to the scientists in the next building,” Elrich said.

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AbelZeta logo with TM Logo

FDA Grants RMAT Designation to AbelZeta’s C-CAR168 for Refractory Lupus

By News, News Archive

AbelZeta logo with TM LogoROCKVILLE, Md.May 27, 2025 /PRNewswire/ — AbelZeta Pharma, Inc. (“AbelZeta” or the “Company”), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational therapy, C-CAR168, for the treatment of refractory Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN).

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Rapa

Baltimore’s Rapafusyn Selected for Roche Accelerator to Tackle Challenging Drug Targets

By News, News Archive

RapaBaltimore, MD, May 27, 2025 —Rapafusyn Pharmaceuticals Inc., a leader in non-degrading molecular glues, announced today the joining of the Roche Accelerator, Roche’s innovation hub, which connects pioneering biotechs with Roche’s expertise.  Rapafusyn was selected to join the Roche Accelerator, based on Rapafusyn’s innovative RapaGlue™ platform and promising pipeline of potential first-in-class and best-in-class therapeutics.

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Cel Sci

CEL-SCI Announces Closing of Public Offering

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Cel SciVIENNA, Va.–(BUSINESS WIRE)–CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a clinical stage cancer immunotherapy company, today announced the closing of its underwritten public offering of 2,000,000 shares of its common stock at a public offering price of $2.50 per share. Total gross proceeds from the offering, before deducting the underwriting discount and other offering expenses, were $5,000,000. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 190,000 shares to cover over-allotments at the public offering price, less the underwriting discount.

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USMPerman

USM Chancellor Jay Perman: The Reasons for Undergraduate Research

By News, News Archive

USMPermanUniversity research has grabbed plenty of headlines over the past few months. Not for the breakthroughs that propel so much of American innovation. Not for the work that advances our health and well-being, that protects our safety, our security, our sustainability. Even so, the discoveries keep coming.

No, the new headlines about academic research deal in the grave threats it now faces: massive cuts in the way university R&D is funded, the revocation of grants that don’t align with federal priorities, the slow-walking of new grant approvals.

Defending science and scientific inquiry is vital right now, for all the reasons you might imagine—and for one you might not. When academic research is an integrated, meaningful part of the undergraduate experience, it develops students into more critical and creative thinkers, better communicators, collaborators, and problem solvers. Undergraduate research builds learners’ confidence and focuses their career plans. It predicts better grades and graduation rates, and reduces equity gaps, particularly in STEM. Students consistently say that research is among the most valuable components of their college career.

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Senseonics

Senseonics Raises $77.8M Through Public Offering and Private Placement

By News, News Archive

SenseonicsGERMANTOWN, Md., May 21, 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 the closing of its previously announced underwritten public offering of a total of 115,000,000 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase up to an additional 15,000,000 shares of common stock, at a public offering price of $0.50 per share.

The aggregate gross proceeds from the public offering, before deducting underwriting discounts and commissions and offering expenses were $57.5 million. All of the shares in the offering were sold by Senseonics.

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ReGelTec

ReGelTec Receives CE Mark for HYDRAFIL® System to Treat Chronic Low Back Pain

By News, News Archive

ReGelTecCE Mark approval for the HYDRAFIL System was granted based on a clinical study of 75 patients that showed that those treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability. Results demonstrated a more than 80% improvement in Oswestry Disability Index (ODI) scores and greater than 70% reduction in Numeric Pain Rating Scale scores after HYDRAFIL treatment, with reductions sustained for two years in the 63 patients that have completed their two-year follow-up visit.

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quoin

Quoin Pharmaceuticals Announces FDA Clearance to Initiate Second Pivotal Whole Body QRX003 Netherton Syndrome Clinical Study

By News, News Archive

quoinASHBURN, Va., May 22, 2025 (GLOBE NEWSWIRE) — Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces FDA clearance to initiate a second Netherton Syndrome (NS) pivotal clinical study CL-QRX003-002 for QRX003. Quoin’s lead product, QRX003, is a topical lotion formulated with a broad-spectrum serine protease inhibitor that has been shown to significantly downregulate the hyperactivity of the kallikreins in the skin responsible for the excessive skin shedding associated with this disease. Clinical data from Quoin’s ongoing studies has demonstrated clear evidence of rapid, prolonged and almost complete skin healing following twice-daily application of QRX003 to the treatment areas along with the almost complete elimination of key symptoms such as chronic, debilitating pruritus and has facilitated zero nightly sleep disturbances.

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GeneDX2

GeneDx Publishes Pioneering Vision for Applying AI to Genomics to Improve and Expedite Diagnosis of Genetic Disease at Scale

By News, News Archive

GeneDX2GAITHERSBURG, Md.–(BUSINESS WIRE)–GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced the publication of a new article in the American Journal of Medical Genetics, demonstrating GeneDx’s leadership in applying artificial intelligence (AI) to accelerate and enhance genetic diagnostics. The article was published as part of an essay collection written by global experts addressing how AI is shaping, and will continue to shape, the future of medical genetics.

The GeneDx-authored article, “AI in the Clinical Genomics Laboratory,” underscores the promise of harnessing AI to increase diagnostic yield, reduce manual workflows, and scale precision medicine for all patients with suspected genetic conditions.

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stacked

HHS layoffs create ‘clear opportunity’ for local health, life sciences companies to add talent — BHI CEO Rich Bendis shares insights with the Washington Business Journal

By News, News Archive

stackedBy Sara Gilgore – Staff Reporter, Washington Business Journal – May 21, 2025 – Once the Department of Health and Human Services unveiled a plan to cut 10,000 positions, United Therapeutics Corp. didn’t waste time.

The publicly traded Silver Spring drugmaker saw an opportunity to scoop up some of that talent, hiring a handful of former HHS employees, including from the Food and Drug Administration, and entering into consulting agreements with others, according to Dewey Steadman, UT’s head of investor relations. The 1,305-person company, which counts about 250 D.C.-area employees, has even created a role for one professional with “specific skills that are critical to us,” he said.

United Therapeutics (NASDAQ: UTHR) isn’t alone. AstraZeneca, Lonza Group, Kite Pharmaceuticals and Thermo Fisher Scientific are among the local life sciences firms actively hiring, and while no one is cheering the loss of so many public-sector jobs, “there’s a clear opportunity to connect federal talent with private-sector innovation,” said Richard Bendis, president and CEO of Rockville’s BioHealth Innovation Inc.

“These are folks with deep regulatory, scientific, and policy expertise who know how to navigate complex systems and bring big ideas to life,” Bendis said. “And in a region like ours, that’s a serious asset.”

 

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