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659th Edition, June 3, 2025

By BHI Weekly News Archives

 

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June 3, 2025

Banking with Heart: Rick Wieczorek on Financial Solutions for the Biohealth Community on BioTalk
In this episode of BioTalk, we welcome Rick Wieczorek, President and CEO of the NIH Federal Credit Union (NIHFCU), to discuss how credit unions like NIHFCU are uniquely positioned to support the biohealth and healthcare communities. With over 40 years of industry experience, Rick shares his journey from teller to CEO and reflects on NIHFCU’s 85-year history, its mission-driven approach to service, and the importance of tailoring financial solutions to meet the needs of life science professionals. He also explains the benefits of membership, the value of the NIHFCU “At Work” program for employers, and how the credit union’s “Banking with Heart” philosophy is making a difference across the BioHealth Capital Region.

Listen now via your favorite podcasting platform:
Apple –  https://apple.co/4jrwyi8
Spotify – https://spoti.fi/4km1v8L
iHeart – https://ihr.fm/3T0HZlY
Amazon – https://amzn.to/3FIwdts
YouTube – https://bit.ly/3T22kYd
TuneIn – https://bit.ly/3T8MgUt

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June 10, 2025 Webinar: Turning Uncertainty to Opportunity: Mastering Government Funding in 2025

Navigating the Shifting Federal Funding Landscape

Strategies, Insights, and AI-Driven Approaches for Winning Non-Dilutive Capital

The federal funding landscape is undergoing a significant transformation. With a new administration in office, the dynamics of securing non-dilutive capital are shifting—requiring organizations to move strategically and with precision to stay ahead. In this high-impact 45-minute session, Grant Engine and BioHealth Innovation bring together their leadership to break down the latest changes, clarify what remains uncertain, and showcase what top-performing companies are doing right now to secure meaningful, large-scale funding.

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Cartesian Therapeutics Announces First Participant Enrolled in Phase 3 Trial of Descartes-08 for Myasthenia Gravis
FREDERICK, Md., May 30, 2025 (GLOBE NEWSWIRE) — Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“Cartesian” or the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced that the first participant has been enrolled in its Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (MG).

Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous engineered chimeric antigen receptor T-cell therapy (CAR-T) product candidate targeting B-cell maturation antigen (BCMA). Descartes-08 is designed to be administered without preconditioning chemotherapy in an outpatient setting and does not use integrating vectors.

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NIH OTT’s Tara Kirby Selected as IAM Market Maker
GERMANTOWN, 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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Introducing the HJF-MDC Venture Fund: Fostering Medical Innovations for Military and Civilian Applications
Bethesda, Maryland – The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) and MDC Studio, Inc (MDC) are proud to announce their groundbreaking collaboration through the HJF-MDC Venture Fund LLC.

This collaboration aims to revolutionize medical technology development and commercialization, benefiting military and civilian health care sectors.

The HJF-MDC Collaboration

This new initiative seeks to grow existing collaborations to accelerate the development and commercialization of dual-use medical technologies for military and civilian applications. As part of this initiative, MDC Studio has established a satellite office within HJF’s innovation facility in Bethesda, Maryland.

Introducing the HJF-MDC Venture Fund

HJF and MDC formed the HJF-MDC Venture Fund, as an independent entity that aims to invest in a diversified portfolio of early-stage companies commercializing military medical technologies with civilian applications. HJF is participating as a non-voting member of the Fund with a minority interest. The Fund’s focus areas include medical devices, wearables for health, and rehabilitation / assistive robotics. The Fund will be overseen by a Board of Managers, who will make investment decisions based on objective selection criteria, including alignment with military medical needs, benefits to civilian health, risks, and expected returns.

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Bizjournals: Virginia Tech seeks industry partners for Institute for Advanced Computing
By Nate Doughty – Staff Reporter, Washington Business Journal – Virginia Tech this week unveiled the Institute for Advanced Computing at its Potomac Yard campus to offer academic and research opportunities in AI and quantum computing — and it’s looking for more companies to work with.

At buildout, the institute will employ 50 full-time faculty members and occupy about a third of Virginia Tech’s Academic Building One, a $302 million, 300,000-square-foot facility in Alexandria that opened in January. That’s all somewhat subject to grant funding, enrollment and the total number of partnerships, according to Kirk Cameron, professor of computer science at Virginia Tech and interim director of the institute.

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Maryland Matters: Proposed Metro station development tied to growth of life sciences in Montgomery County
State 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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Danaher Announces Diagnostic Development and Commercialization Partnership to Scale Precision Medicine
WASHINGTON, May 29, 2025 /PRNewswire/ — Danaher Corporation (NYSE: DHR) (“Danaher”), a global science and technology innovator, announced today the launch of a partnership with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop and commercialize novel diagnostic tools and tests intended to help clinicians better determine which patients would most benefit from precision medicine treatments.

“Precision medicines are more targeted than standard therapies and thus require precision diagnostics to determine which patients are most likely to benefit,” said Julie Sawyer Montgomery, Danaher Executive Vice President. “We are excited to work with AstraZeneca on the goal of creating novel tests to increase access to precision medicines, helping ensure that no patients are left behind.”

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FDA Grants RMAT Designation to AbelZeta’s C-CAR168 for Refractory Lupus
ROCKVILLE, 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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Baltimore’s Rapafusyn Selected for Roche Accelerator to Tackle Challenging Drug Targets
Baltimore, 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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Virginia Business: GO Virginia grant boosts biotech in Roanoke, New River Valley
Ralph Berrier Jr. //June 1, 2025// – A $4.9 million grant from the commonwealth will allow leaders from the  and New River valleys to build upon efforts by  Carilion School of Medicine and the Fralin Biomedical Institute at VTC to turn the region into a hub for .

“As we build the biotech sector, this statewide grant will help us where we have gaps,” explains Erin Burcham, CEO of the Roanoke Blacksburg Innovation Alliance (RBIA), a regional  organization.

The money is a slice of a $14.3 million pie from state economic development initiative  to fund the multiregional Project VITAL (Virginia Innovations and Technology Advancements in Life Sciences), an endeavor to make Virginia a biotechnology leader.

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Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025
Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.

In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.

A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

Read More

Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 

658th Edition, May 28, 2025

By BHI Weekly News Archives

 

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May 28, 2025

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 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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USM Chancellor Jay Perman: The Reasons for Undergraduate Research
University 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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REGENXBIO Announces Strategic Royalty Monetization Agreement for Up to $250 Million

ROCKVILLE, Md., May 19, 2025 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced the closure of a non-dilutive, limited recourse royalty bond agreement of up to $250 million with Healthcare Royalty (HCRx). This agreement monetizes select anticipated royalties and milestones, and provides both immediate and expected future, non-dilutive capital.  REGENXBIO received $150 million at closing, extending the Company’s expected cash runway into early 2027.

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Senseonics Raises $77.8M Through Public Offering and Private Placement
GERMANTOWN, 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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CEL-SCI Announces Closing of Public Offering
VIENNA, 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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ReGelTec Receives CE Mark for HYDRAFIL® System to Treat Chronic Low Back Pain
CE 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.

Read More

Webinar: Turning Uncertainty to Opportunity: Mastering Government Funding in 2025

Navigating the Shifting Federal Funding Landscape

Strategies, Insights, and AI-Driven Approaches for Winning Non-Dilutive Capital

The federal funding landscape is undergoing a significant transformation. With a new administration in office, the dynamics of securing non-dilutive capital are shifting—requiring organizations to move strategically and with precision to stay ahead. In this high-impact 45-minute session, Grant Engine and BioHealth Innovation bring together their leadership to break down the latest changes, clarify what remains uncertain, and showcase what top-performing companies are doing right now to secure meaningful, large-scale funding.

Read More

Altimmune Announces Initiation of RECLAIM Phase 2 Trial Evaluating the Efficacy and Safety of Pemvidutide in Alcohol Use Disorder (AUD)
GAITHERSBURG, Md., May 19, 2025 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that it has enrolled the first subject in the RECLAIM Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol Use Disorder (AUD). Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), obesity, AUD and alcohol liver disease (ALD). IMPACT, a Phase 2b trial of pemvidutide in MASH, is expected to read out topline data in the second quarter of 2025, and a Phase 2 trial of pemvidutide in ALD is expected to initiate enrollment in the third quarter of 2025.

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GeneDx Publishes Pioneering Vision for Applying AI to Genomics to Improve and Expedite Diagnosis of Genetic Disease at Scale
GAITHERSBURG, 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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Quoin Pharmaceuticals Announces FDA Clearance to Initiate Second Pivotal Whole Body QRX003 Netherton Syndrome Clinical Study
ASHBURN, 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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Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025
Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

Read More

Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 

657th Edition, May 20, 2025

By BHI Weekly News Archives

 

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May 20, 2025

Maryland Stem Cell Research Fund Awards Over $18 Million to Drive Breakthroughs in Regenerative Medicine
Awardees receive funding to accelerate research and development of stem cell therapiesCOLUMBIA, Md., (May 13, 2025) — The Maryland Stem Cell Research Commission (“Commission”) announced awarding over $18 million in grants aimed at accelerating cutting-edge stem cell and regenerative medicine research across Maryland.This funding supports 52 investigators from top Maryland based research institutions and companies working on almost 50 different medical conditions and diseases including sickle cell anemia, diabetes, cancers and chronic pain to diseases directed to heart, bone, blood, digestive and neurological conditions. This year’s grant recipients feature innovative companies such as Seraxis Inc., Britecyte Inc., SereNeuro Therapeutics Inc. and Diagnostic Biochips, Inc. They are joined by academic researchers from Johns Hopkins University, University of Maryland, Baltimore, University of Maryland, College Park, University of Maryland, Baltimore County and the Uniformed Services University of Health Sciences/Henry Jackson Foundation. The University of Maryland, Eastern Shore is newly represented among this year’s funded institutions, strengthening statewide support for regenerative medicine research.

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Remedy Plan Therapeutics Raises $18 Million Financing to Accelerate Advancement of Lead Asset RPT1G into Phase 1/2 Trials
GAITHERSBURG, Md., May 13, 2025 (GLOBE NEWSWIRE) — Remedy Plan Therapeutics (Remedy Plan), a privately-held, clinical-stage pharmaceutical company developing novel, hyperbolic NAMPT inhibitors, today announced the company has raised over $18 million in an oversubscribed insider financing round. The round includes participation from Schooner Capital and Alexandria Venture Investments. This brings the company’s total funding to date to $55 million.The financing will accelerate the advancement of the company’s first-in-class NAMPT inhibitor, RPT1G, into a Phase 1/2 clinical study in patients with AML or high-risk MDS. This builds on the momentum of an ongoing first-in-human study in healthy adults (NCT06667765), which will conclude later this month. The investment will also support the continued development of Remedy Plan’s pipeline of NAMPT inhibitors with applications across solid tumors, autoimmune diseases, and obesity.

Read More

Altimmune Secures Up to $100 Million in Credit Facility from Hercules Capital

GAITHERSBURG, Md., May 13, 2025 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that it has entered into an agreement with Hercules Capital, Inc. (NYSE: HTGC), a leader in debt financing for life science companies, for up to $100 million in a credit facility, with a $15 million tranche funded at closing. Additional tranches will become available upon achievement of certain clinical and financial milestones aligned with the Company’s pemvidutide development plans and financing needs.

Read More

FDA Accepts REGENXBIO’s Application for Priority Review of Gene Therapy for Hunter Syndrome (MPS II)
ROCKVILLE, Md., May 13, 2025 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) seeking accelerated approval for clemidsogene lanparvovec (RGX-121) for the treatment of Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome.The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of November 9, 2025.

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VPM: Mark Esser wants to make Charlottesville the Silicon Valley of biotech
By Phil Liles: The University of Virginia has named Mark Esser as the first chief scientific officer of the upcoming Paul and Diane Manning Institute of Biotechnology.Esser will work with scientists to accelerate the development of new medicines and treatments for illnesses like cancer and Alzheimer’s.Morning Edition Host Phil Liles spoke with Esser about his desire to turn a corner on incurable diseases, which he noted, requires significant federal funding. That funding is now uncertain as President Donald Trump halts $1.8 billion dollars in grants from the National Institutes of Health.

Read More

Senseonics Announces Commencement of $50 Million Public Offering of Common Stock and Concurrent Private Placement
GERMANTOWN, Md., May 15, 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 that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock. In connection with the proposed offering, Senseonics also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the total number of shares of common stock offered in the public offering. All of the shares of common stock to be sold in the proposed offering will be offered by Senseonics.

Read More

Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025
Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

Read More

Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 

BioHealth Innovation Weekly for May 20, 2025

By Uncategorized

 

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May 20, 2025

Maryland Stem Cell Research Fund Awards Over $18 Million to Drive Breakthroughs in Regenerative Medicine
Awardees receive funding to accelerate research and development of stem cell therapies

COLUMBIA, Md., (May 13, 2025) — The Maryland Stem Cell Research Commission (“Commission”) announced awarding over $18 million in grants aimed at accelerating cutting-edge stem cell and regenerative medicine research across Maryland.

This funding supports 52 investigators from top Maryland based research institutions and companies working on almost 50 different medical conditions and diseases including sickle cell anemia, diabetes, cancers and chronic pain to diseases directed to heart, bone, blood, digestive and neurological conditions. This year’s grant recipients feature innovative companies such as Seraxis Inc., Britecyte Inc., SereNeuro Therapeutics Inc. and Diagnostic Biochips, Inc. They are joined by academic researchers from Johns Hopkins University, University of Maryland, Baltimore, University of Maryland, College Park, University of Maryland, Baltimore County and the Uniformed Services University of Health Sciences/Henry Jackson Foundation. The University of Maryland, Eastern Shore is newly represented among this year’s funded institutions, strengthening statewide support for regenerative medicine research.

Read More

Remedy Plan Therapeutics Raises $18 Million Financing to Accelerate Advancement of Lead Asset RPT1G into Phase 1/2 Trials
GAITHERSBURG, Md., May 13, 2025 (GLOBE NEWSWIRE) — Remedy Plan Therapeutics (Remedy Plan), a privately-held, clinical-stage pharmaceutical company developing novel, hyperbolic NAMPT inhibitors, today announced the company has raised over $18 million in an oversubscribed insider financing round. The round includes participation from Schooner Capital and Alexandria Venture Investments. This brings the company’s total funding to date to $55 million.

The financing will accelerate the advancement of the company’s first-in-class NAMPT inhibitor, RPT1G, into a Phase 1/2 clinical study in patients with AML or high-risk MDS. This builds on the momentum of an ongoing first-in-human study in healthy adults (NCT06667765), which will conclude later this month. The investment will also support the continued development of Remedy Plan’s pipeline of NAMPT inhibitors with applications across solid tumors, autoimmune diseases, and obesity.

Read More

Altimmune Secures Up to $100 Million in Credit Facility from Hercules Capital

GAITHERSBURG, Md., May 13, 2025 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that it has entered into an agreement with Hercules Capital, Inc. (NYSE: HTGC), a leader in debt financing for life science companies, for up to $100 million in a credit facility, with a $15 million tranche funded at closing. Additional tranches will become available upon achievement of certain clinical and financial milestones aligned with the Company’s pemvidutide development plans and financing needs.

Read More

FDA Accepts REGENXBIO’s Application for Priority Review of Gene Therapy for Hunter Syndrome (MPS II)
ROCKVILLE, Md., May 13, 2025 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) seeking accelerated approval for clemidsogene lanparvovec (RGX-121) for the treatment of Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome.

The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of November 9, 2025.

Read More

 

VPM: Mark Esser wants to make Charlottesville the Silicon Valley of biotech
By Phil Liles: The University of Virginia has named Mark Esser as the first chief scientific officer of the upcoming Paul and Diane Manning Institute of Biotechnology.

Esser will work with scientists to accelerate the development of new medicines and treatments for illnesses like cancer and Alzheimer’s.

Morning Edition Host Phil Liles spoke with Esser about his desire to turn a corner on incurable diseases, which he noted, requires significant federal funding. That funding is now uncertain as President Donald Trump halts $1.8 billion dollars in grants from the National Institutes of Health.

Read More

Senseonics Announces Commencement of $50 Million Public Offering of Common Stock and Concurrent Private Placement
GERMANTOWN, Md., May 15, 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 that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock. In connection with the proposed offering, Senseonics also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the total number of shares of common stock offered in the public offering. All of the shares of common stock to be sold in the proposed offering will be offered by Senseonics.

Read More

Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025
Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.

In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.

A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

Read More

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656th Edition, May 12, 2025

By BHI Weekly News Archives

 

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May 12, 2025

From Classroom to Clinic: Neopenda’s Global Health Journey with CEO Sona Shah on BioTalk
In this episode of BioTalk, host Rich Bendis welcomes Sona Shah, CEO and Co-Founder of Neopenda, for an inspiring conversation on innovation, impact, and scaling medical technology in underserved markets. Sona shares how a formative experience teaching in rural Kenya ignited her passion for global health, leading to the creation of neoGuard, a wearable vital signs monitor tailored for low-resource settings. This episode builds on a recent article featured on the BHI News page, offering a deeper look into Neopenda’s journey, innovations, and impact in global health.

They discuss the engineering challenges of building clinical-grade hardware for hospitals with limited infrastructure, the company’s growth from Maryland’s Relevant Health accelerator, and the deployment of over 350 devices across East and West Africa. Sona also talks about Neopenda’s next wave of products, lessons in balancing cost and quality, and the importance of community, resilience, and mission-driven entrepreneurship.

Listen now on your favorite podcast platforms:
Apple – https://apple.co/4k9XSmp
Spotify – https://spoti.fi/3F4U1rk
iHeart – https://ihr.fm/3Z90W9G
YouTube Podcasts – https://bit.ly/3Zcfoxy
Amazon Podcasts – https://amzn.to/454f2ge
TuneIn – https://bit.ly/3Fe2YhU

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WBJ: AstraZeneca unveils $300M Rockville investment, a boost for MoCo amid federal cuts
By Sara Gilgore – Staff Reporter, Washington Business Journal – 

AstraZeneca PLC (NYSE: AZN) has opened a new Rockville manufacturing hub, a whopping $300 million investment for the British pharmaceutical giant — and a big win for Montgomery County in a tough moment for the sector locally.

The company, which held a ribbon-cutting event Monday, intends to use its 85,000-square-foot Rockville Manufacturing Center at 9950 Medical Center Drive to initially make T-cell therapies for clinical trials in cancer. It had unveiled its plans for the project last February and is now getting ready to move people in.

“Rockville represents the future of manufacturing,” an AstraZeneca spokesperson told me over email, noting the space was built out using 3D-modeling, virtual reality and artificial intelligence, which helped speed up operational and construction timelines.

Read More

 

The NCI Technology Transfer Center NIH Technology Opportunity Webinar: Radiolabeled Sugars for Imaging of Fungal Infections

The NCI Technology Transfer Center has an upcoming NIH Technology Opportunity Webinar
May 28, 2025 | 11:00 AM ET
Radiolabeled Sugars for Imaging of Fungal Infections
Hosted by Joseph Conrad | Featuring Dr. Dima A. Hammoud

Join this free webinar to learn about a novel PET radiotracer, [18F]-fluorocellobiose ([18F]-FCB), developed by NIH researchers. Unlike standard FDG, this agent targets fungal-specific metabolism, enabling early, non-invasive detection and real-time monitoring.

This technology addresses a critical need in diagnosing fungal infections in immunocompromised patients.

https://bit.ly/3Srhfe9

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GeneDx Announces Completion of Fabric Genomics Acquisition
GAITHERSBURG, Md. & OAKLAND, Calif.–(BUSINESS WIRE)–GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced the successful completion of its acquisition of Fabric Genomics, a pioneer in AI-powered genomic interpretation. Together, GeneDx and Fabric Genomics are ushering in the next era of genomic medicine, enabling decentralized testing powered by centralized intelligence to set the standard of care across the globe.

“Healthcare is at an inflection point where genomic insights must be integrated into standard care to improve outcomes and reduce costs,” said Katherine Stueland, President and CEO of GeneDx. “With Fabric Genomics now part of GeneDx, we’re uniquely positioned to deliver earlier and more accurate diagnoses worldwide, from NICUs and pioneering newborn screening programs to health systems across the globe.”

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Theriva Biologics Announces Pricing of $7.5 Million Public Offering
ROCKVILLE, Md., May 07, 2025 (GLOBE NEWSWIRE) — Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the pricing of its “reasonable best efforts” public offering for the purchase and sale of up to 6,818,180 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 6,818,180 shares of common stock at a combined offering price of $1.10 per share and accompanying warrant (the “Offering”). The Company expects to receive aggregate gross proceeds of approximately $7.5 million, before deducting placement agent fees and other offering expenses, and assuming no exercise of the warrants. The warrants will have an exercise price of $1.10 per share, will be exercisable immediately and will expire five years from the issuance date.

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Galimedix Completes First Phase 1 Dosing of Oral Alzheimer’s Drug GAL-101
KENSINGTON, Md. and MUNICH and MARTINSRIED, Germany, May 06, 2025 (GLOBE NEWSWIRE) — Galimedix Therapeutics, Inc. (“Galimedix”), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious brain and eye diseases, today announced the completion of the single ascending dose (SAD) part of the Phase 1 study with orally administered GAL-101, a small molecule specifically designed to target misfolded amyloid beta (Aβ) monomers.

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TEDCO’s Tammi Thomas Elected President of the Maryland Economic Development Association
COLUMBIA, Md., (May 7, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced the appointment of its chief development and marketing officer, Tammi Thomas, as the elected president of the Maryland Economic Development Association’s (MEDA) Board of Directors. She began her two-year term on April 28, 2025, during the MEDA Annual Conference.

Thomas’ leadership comes as the organization reaches a record high of 576 members, marking a new chapter for MEDA as it continues to promote inclusive economic growth throughout Maryland. In addition to record breaking membership numbers, the organization finished the conference by raising more than $12,000 during the annual silent auction for the Rhonda Ray Scholarship and the Lofton Scholarship Fund. These two unique scholarship opportunities offer support to individuals in economic development or public policy courses.

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Beyond the Device: Neopenda’s Human-Centered Approach to Health Tech
More than a decade ago, a young engineer named Sona Shah stepped into a classroom in rural Kenya—and the beginning of a life-changing journey. What she witnessed there didn’t just shape her understanding of global health disparities; it set her on a path to build solutions for those often left behind. Today, as CEO and Co-Founder of Neopenda, Shah is leading a growing team that’s redefining how clinical care is delivered in low-resource settings around the world. The company’s mission is simple but urgent: develop innovative, sustainable medical technologies that make high-quality care accessible to everyone.

Shah’s inspiration for Neopenda was born from lived experience. After earning her degree in chemical engineering, she spent time teaching in western Kenya, where preventable illness and lack of access to healthcare were daily realities. “That experience planted a seed,” she said. “I couldn’t stop thinking about the kids I had taught, and the families around them who deserved more.” Returning to the U.S., Shah pursued a master’s in biomedical engineering at Columbia University, where she met her co-founder, Teresa Cauvel. A needs-assessment trip to Uganda exposed the two to hospitals filled with critically ill newborns, overwhelmed nurses, and donated medical equipment that sat broken and unused. “It became crystal clear that the issue wasn’t just a lack of resources—it was a lack of thoughtful design,” she said.

This realization laid the foundation for neoGuard™, Neopenda’s flagship product: a wearable, clinical-grade vital signs monitor designed for low-resource environments. “We didn’t want to create just another device—we wanted to build something with and for the clinicians on the frontlines,” Shah explained. Designed to monitor heart rate, respiratory rate, oxygen saturation, and temperature, neoGuard is battery-powered, lightweight, and built to function in settings where reliable power and infrastructure are not guaranteed.

Read More

Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025
Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.

In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.

A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

Read More

Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 

655th Edition, May 6, 2025

By BHI Weekly News Archives

 

Trouble Viewing This Email: Click Here

May 6, 2025

 

Beyond the Device: Neopenda’s Human-Centered Approach to Health Tech
More than a decade ago, a young engineer named Sona Shah stepped into a classroom in rural Kenya—and the beginning of a life-changing journey. What she witnessed there didn’t just shape her understanding of global health disparities; it set her on a path to build solutions for those often left behind. Today, as CEO and Co-Founder of Neopenda, Shah is leading a growing team that’s redefining how clinical care is delivered in low-resource settings around the world. The company’s mission is simple but urgent: develop innovative, sustainable medical technologies that make high-quality care accessible to everyone.

Shah’s inspiration for Neopenda was born from lived experience. After earning her degree in chemical engineering, she spent time teaching in western Kenya, where preventable illness and lack of access to healthcare were daily realities. “That experience planted a seed,” she said. “I couldn’t stop thinking about the kids I had taught, and the families around them who deserved more.” Returning to the U.S., Shah pursued a master’s in biomedical engineering at Columbia University, where she met her co-founder, Teresa Cauvel. A needs-assessment trip to Uganda exposed the two to hospitals filled with critically ill newborns, overwhelmed nurses, and donated medical equipment that sat broken and unused. “It became crystal clear that the issue wasn’t just a lack of resources—it was a lack of thoughtful design,” she said.

This realization laid the foundation for neoGuard™, Neopenda’s flagship product: a wearable, clinical-grade vital signs monitor designed for low-resource environments. “We didn’t want to create just another device—we wanted to build something with and for the clinicians on the frontlines,” Shah explained. Designed to monitor heart rate, respiratory rate, oxygen saturation, and temperature, neoGuard is battery-powered, lightweight, and built to function in settings where reliable power and infrastructure are not guaranteed.

Read More

Successful 2nd Annual “Stem Cell and Regenerative Medicine Tech Showcase” Held on April 29, 2025
Innovators in Regenerative Medicine Gathered to Drive Healing and Hope

BALTIMORE, MD. | May 6, 2025 – The Maryland Stem Cell Research Fund (MSCRF) in collaboration with the Maryland Department of Commerce capped off a successful Tech Showcase featuring nearly 200 companies, entrepreneurs, scientists, investors, and other stakeholders from the regenerative medicine sector. All gathered to share breakthroughs and forge new collaborations within Maryland’s vibrant biotech ecosystem. The event spotlighted cutting-edge stem cell technologies poised to become the cures of tomorrow.

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Emergent BioSolutions Announces Agreement to Supply the Ontario Ministry of Health with NARCAN®
WINNIPEG, Manitoba, May 01, 2025 (GLOBE NEWSWIRE) — Today, Emergent BioSolutions Inc. (NYSE: EBS) announced a maximum three-year agreement with a value of approximately $65 million to supply the Ontario Ministry of Health with NARCAN® Nasal Spray for the Ontario Naloxone Program (ONP). Since 2018, Emergent has supported the Ontario Ministry of Health to provide access to NARCAN® Nasal Spray across the province. NARCAN® Nasal Spray is designed to reverse the effects of an opioid poisoning in minutes and is the only 4 mg, intranasal naloxone spray in Canada with a shelf life of four years (48 months).

Read More

RoosterBio Announces Collaboration with Thermo Fisher Scientific to Advance Cell and Exosome Therapy Manufacturing
FREDERICK, Md., April 30, 2025 /PRNewswire/ — RoosterBio, Inc., a leading supplier of adult human mesenchymal stem/stromal cells (hMSCs), highly engineered media, and bioprocess development services, today announced a new collaboration with Thermo Fisher Scientific, the world leader in serving science. This collaboration aims to accelerate the availability of new, potentially life-saving cell and exosome therapies that have the potential to revolutionize the treatment of degenerative disease.

Read More

VerImmune Awarded ~$470K CDMRP Grant to Drive Innovation in ViP-Based Therapeutics for Advanced Melanoma
Washington DC & Singapore – April 29th, 2025- VerImmune, Inc. (“VerImmune”), a biotechnology company developing innovative Virus-inspired Particle (ViP) modalities, announced today it has been awarded a ~$470,000 USD research grant (MRP Idea Award) from the U.S. Department of Defense (DoD) Melanoma Research Program (MRP), managed by the office of Congressionally Directed Medical Research Programs (CDMRP).

The award will support the development of novel candidates based on VerImmune’s ViP technology for the treatment of advanced or rare melanoma cancers.

Read More

UMSOM: New Innovation Alliance Aims to Drive New Med Tech Ventures In Region
April 28, 2025 | Jon Kelvey – A new collaboration bringing entrepreneurs and investors together with physician-scientists, surgeons, and medical technologists promises to launch the Baltimore region as a major national hub for new biomedical ventures and start-up companies. The initiative, called the “Innovation Alliance,” leverages the region’s national and international leadership in biomedical research and technology to attract venture capital, foster startups, drive economic growth, and ultimately bring to market new treatments, cures, and technologies that will directly improve lives.

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PQE Group US Earns Great Place to Work Certification™
Over $1 million awarded to 7 university projects 

For its fourth consecutive year, the company is recognized with this certification

Rockville, MD, May 5, 2025. PQE Group is proud to announce that, for the fourth consecutive year, its US subsidiary has been Certified™ by Great Place To Work®. This prestigious award is based entirely on what current employees say about their experience working at PQE Group US. This year, 92% of survey respondents in the US said it’s a great place to work. To obtain this recognition, PQE Group’s US employees completed a voluntary survey, responding to numerous questions regarding their satisfaction in a wide array of areas surrounding PQE Group’s company culture, including leadership behaviors and support, collaboration, inclusion, integrity, communication, and more.

Great Place to Work® is the global authority on workplace culture, employee experience, and the leadership behaviors proven to deliver market-leading revenue, employee retention and increased innovation.

Read More

BioHealth at a Crossroads: Alex Philippidis on Policy Shifts, Investment Trends, and What’s Ahead on BioTalk
In this timely episode of BioTalk, returning guest Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News, joins host Rich Bendis to explore how sweeping changes in U.S. regulatory policy, workforce dynamics, and economic pressures are affecting the biotech industry in real time.

Listen now via your favorite podcasting platforms:
Apple: https://apple.co/3EHj6IE
Spotify: https://spoti.fi/3EIid2q
iHeart: https://ihr.fm/3Ykuq46
Amazon: https://amzn.to/4jR5byw
YouTubePodcasts: https://bit.ly/4lQrHcD
TuneIn: https://bit.ly/2M60Wmx

Alex breaks down the potential consequences of FDA workforce cuts, particularly for small and mid-sized biotechs that depend on regulatory guidance, and offers perspective on how HHS and NIH budget proposals could reshape the national innovation infrastructure. The conversation covers everything from the impact of tariffs on manufacturing and supply chains to the slowing pace of M&A activity and venture capital investment trends. Alex also shares his insights on IPO strategy shifts, and whether the current biotech environment is poised for a rebound—or a broader realignment with global competitors. This is a must-listen episode for anyone navigating the uncertain waters of biotech in 2025.

Read More

Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025
Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.

In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.

A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

Read More

Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 

654th Edition, April 29, 2025

By BHI Weekly News Archives

 

Trouble Viewing This Email: Click Here

April 29, 2025

BioHealth at a Crossroads: Alex Philippidis on Policy Shifts, Investment Trends, and What’s Ahead on BioTalk
In this timely episode of BioTalk, returning guest Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News, joins host Rich Bendis to explore how sweeping changes in U.S. regulatory policy, workforce dynamics, and economic pressures are affecting the biotech industry in real time.

Listen now via your favorite podcasting platforms:
Apple: https://apple.co/3EHj6IE
Spotify: https://spoti.fi/3EIid2q
iHeart: https://ihr.fm/3Ykuq46
Amazon: https://amzn.to/4jR5byw
YouTubePodcasts: https://bit.ly/4lQrHcD
TuneIn: https://bit.ly/2M60Wmx

Alex breaks down the potential consequences of FDA workforce cuts, particularly for small and mid-sized biotechs that depend on regulatory guidance, and offers perspective on how HHS and NIH budget proposals could reshape the national innovation infrastructure. The conversation covers everything from the impact of tariffs on manufacturing and supply chains to the slowing pace of M&A activity and venture capital investment trends. Alex also shares his insights on IPO strategy shifts, and whether the current biotech environment is poised for a rebound—or a broader realignment with global competitors. This is a must-listen episode for anyone navigating the uncertain waters of biotech in 2025.

Read More

Phlow Corp. Expands Analytical Capabilities and Embraces Artificial Intelligence-Driven System, Ushering in a New Era of Modern Medicine Manufacturing in America
Richmond, Virginia, April 22, 2025 (GLOBE NEWSWIRE) — Phlow Corp., a leading pharmaceutical contract development and manufacturing organization (CDMO) in America, announced today a significant expansion in its analytical capabilities, use of artificial intelligence (AI), workforce, and domestic infrastructure. Marking a period of exceptional growth and momentum, Phlow has more than doubled in size and now employs over 90+ highly skilled scientists and professionals dedicated to building a resilient, high-quality pharmaceutical supply chain on U.S. Soil.

Driven by its strategic purpose to create the future of how medicines are made by helping brilliant minds bring medicines to life through advanced development and manufacturing in America, Phlow has expanded its state-of-the-art laboratories in the Virginia Biotechnology Research Park in Richmond, Virginia. The expansion includes acquiring additional analytical capabilities, including advanced spectroscopy tools and high-resolution, high-mass accuracy mass spectrometry, adjacent to its existing process research and development lab, enabling Phlow’s talented team of scientists to develop and validate analytical methods. This enhancement allows Phlow to streamline processes and foster greater collaboration, ultimately reinforcing our commitment to delivering innovative solutions and high-quality products. Phlow’s expanded laboratory space now offers comprehensive analytical services, including industry-leading analytical solutions for drug assays, impurity characterization and control, purity analysis, and process optimization for cutting-edge technologies such as continuous flow chemistry.

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Lending a Helping Hand: the National Institutes of Health Federal Credit Union
From low-rate loan options to a tech-advanced platform, the National Institutes of Health Federal Credit Union offers compassionate, personalized banking services that save time and money for its members, who predominantly reside in the Washington, D.C., metro area.

Since 1940, the National Institutes of Health Federal Credit Union (NIHFCU) has primarily served the employees and contractors of the National Institutes of Health (NIH) and others simi- larly employed in the biomedical and health care industries. Its extensive experience in these communities positions the credit union to best serve the unique needs of this popula- tion, with branches both in surrounding areas and on NIH campuses. The credit union offers tailored loan programs such as special medical school lines of credit for soon-to-be medical practitioners, student loan refinancing options for current medical practitioners, and unique borrowing options for NIH international fel- lows. Today, NIHFCU makes membership available to virtually anyone, whether they work in or outside of the health care or bio-medical fields.

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Sonavex Receives FDA 510(k) Clearance for EchoMap™ Device
Baltimore, MD (April 28th, 2025) – Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s EchoMap™ device. Sonavex’s EchoMap leverages 3D ultrasound and AI algorithms to empower dialysis technicians without prior ultrasound experience to visualize the target fistula or graft before cannulation.

Read More

Welldoc Certified as a Great Place to Work® for Fourth Consecutive Year
COLUMBIA, Md., April 23, 2025 — Welldoc®, a digital health leader revolutionizing cardiometabolic care, announced today that it was Certified™ by Great Place to Work® for the fourth year in a row. This prestigious award recognizes companies with exceptional workplace cultures based solely on employee feedback. An impressive 94 percent of employees said Welldoc is a great place to work, exceeding the U.S. average by 37 points.

Great Place to Work is the global authority on workplace culture, employee experience and leadership behaviors proven to deliver market-leading revenue, employee retention and increased innovation. The Great Place to Work Certification is based on results of the Trust Index™ survey administered by the Great Place to Work Institute, which assesses employee satisfaction in key areas, including credibility, respect, fairness and camaraderie.

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Carr Tech Corp Celebrates FDA 510(k) Class II Approval of FROG All-in-One Filter Needle
This transformative device advances safety and efficiency in drug preparation, underscoring the startup’s journey from solo founder to FDA-cleared innovator.

FREDERICK, Md., April 25, 2025 /PRNewswire/ — Carr Tech Corp, a Maryland-based medical device startup founded by pharmacist-turned-entrepreneur Sue Carr, proudly announces that the company has received FDA 510(k) Class II clearance for its flagship product, FROG (Filter Removal of Glass), an all-in-one filter needle designed to enhance safety and efficiency in medication preparation and administration.

“I am humbly grateful and happy to announce that we officially received FDA 510(k) Class II approval of FROG,” said Carr. “This milestone is not just a win for Carr Tech—it’s a win for every healthcare worker who’s ever struggled with cumbersome drug prep protocols and every patient who deserves safer medication handling.”

FROG is the first and only all-in-one filter needle that eliminates multiple steps from the current multi-component method of drawing medication from glass ampoules. Traditional procedures often involve using separate filter and non-filter needles to prevent the risk of glass particle contamination—a process that is time-consuming, costly, and prone to error. FROG’s innovative design consolidates these steps, reducing procedural risk, streamlining workflow, and enhancing patient safety.

Read More

Precision for Medicine and PathAI Announce Strategic Collaboration to Advance AI-Powered Clinical Trial Services and Biospecimen Products
Collaboration will deliver innovative AI-powered pathology tools and quality control enhancements to accelerate clinical trials and biomarker discovery

BOSTON and FREDERICK, Md., April 25, 2025 /PRNewswire/ –Precision for Medicine, a leading provider of next generation drug development research and services, and PathAI, a global leader in digital pathology, today announced a strategic collaboration to partner on developing novel AI-based technologies and to integrate PathAI’s advanced digital pathology and analysis capabilities across Precision for Medicine’s clinical trial and biospecimen operations.

This collaboration includes use of several PathAI technologies and establishes an agreement to offer novel tools and analytical services that address emerging needs in biomarker discovery, spatial biology, and tissue-based clinical research. Through this collaboration PathAI’s tools and services will help augment Precision for Medicine’s proprietary pipeline providing biopharma clients with access to imaging workflows offered through Precision for Medicine’s integrated laboratory and clinical trial services.

Read More

TEDCO’s Maryland Innovation Initiative Announces FY2025 Technology Assessment Awards
Over $1 million awarded to 7 university projects 

COLUMBIA, Md., (April 24, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced the next round of Maryland Innovation Initiative (MII)’s Technology Assessment awards, marking a significant milestone in promoting the commercialization of groundbreaking research from Maryland’s prestigious academic research institutions. The Technology Assessment award is a nine-month project that builds on strong preliminary data that demonstrates the technology’s utility for specific commercial applications beyond basic research.

“The Technology Assessment phase of our program provides non-dilutive funding to advance technologies with commercial potential,” said Abi Kulshreshtha, MII’s executive director. “In this award cycle, the Maryland Innovation Initiative staff and technical reviewers selected seven projects from a competitive pool of applicants, which altogether received grants totaling more than $1 million to advance innovations ranging from new cancer therapeutics to inclusive AI-driven education technology solutions.”

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Digitalis Commons – Notes on Catalyzing Health & Changes in the Scientific Stack
The U.S. biomedical innovation system is world-leading, built by a century of federal investment that peaked last year at $50 billion. That foundation has been thrown into uncertainty by shifts in policy under the second Trump Administration aimed to reduce spend, shift research priorities, and divest from universities. While these changes have appeared to many to come on suddenly, they reflect long-growing concerns with the U.S. scientific system—initiated by issues with trust and reproducibility, barriers to accessing knowledge, and structural limitations on creative risk-taking.

The scientific community is actively seeking additional funders to step in and fill the anticipated funding gap, which may be as big as $20B annually. New pledges are starting to be made. At the state level, California is advancing a bill to fund general scientific research and Texas is advancing a bill to fund Alzheimer’s research. Both of these states have a history of scientific funding, including through the California Institute for Regenerative Medicine and the Texas Cancer Prevention and Research Institute of Texas (CPRIT). Corporate pledges are also happening—Recursion Pharmaceuticals has funded a pre-seed accelerator designed to close gaps in SBIR funding—and groups outside of the US are launching opportunities for funding or training that are aimed at US-based scientists. Other potential sources of funding include philanthropies, family offices, regional governments, private investors, disease foundations, and crowd-funding. If contributions from these groups rise to meet the anticipated $20B funding gap, the system will shift fundamentally—from one organized around a central funder to one sustained by a kaleidoscope of funders. This transition will open-up new and interesting opportunities.

Read More

Compremium AG Appoints Dr. Kolaleh Eskandanian to Lead New Division of Pediatrics and Special Populations
Swiss MedTech leader taps renowned pediatric innovation expert to serve as Chief Strategy and Innovation Officer and Head of Pediatrics

BERN, SWITZERLAND / ACCESS Newswire / April 23, 2025 / Compremium AG, a pioneering Swiss medical technology company, announced today the appointment of Kolaleh Eskandanian, PhD, MBA, as Chief Strategy and Innovation Officer and Head of its newly formed Division of Pediatrics and Special Populations.

Dr. Eskandanian, a global leader in pediatric innovation, joins Compremium from Children’s National Hospital in Washington, D.C., where she most recently served as Vice President and Chief Innovation Officer, Executive Director of the Sheikh Zayed Institute for Pediatric Surgical Innovation, and founding executive of Innovation Ventures. Her appointment marks a strategic milestone in Compremium’s expansion into pediatric and special populations, reinforcing its commitment to developing precision diagnostics and next-generation health technologies for patients worldwide.

Read More

BizJournals: Phlow touts expansion, investment in Richmond and Petersburg
By Drew Hansen – Assistant Managing Editor – April 23, 2025 – Richmond pharmaceutical ingredient company Phlow Corp. said Tuesday it has expanded its laboratories at the Virginia Biotechnology Research Park and doubled in size to more than 90 scientists and skilled professionals.

The public benefit corporation said it has expanded its labs by acquiring additional analytical capabilities, including advanced spectroscopy tools to analyze chemical composition and develop and validate analytical methods from its scientists.

Phlow said the new capabilities allow it to streamline its processes and will open it up for more collaboration.

Read More

 

Clasp Therapeutics Begins First Human Trial of New Immune Therapy Designed to Precisely Attack Cancer Cells
Clasp Therapeutics Doses First Patient in Phase 1 Clinical Trial With a First-in-Class T-Cell Engager Designed to Target Cancer Cells With Absolute Specificity

CAMBRIDGE, Mass. & ROCKVILLE, Md.–(BUSINESS WIRE)–Clasp Therapeutics, a biotechnology company bringing unparalleled precision to immuno-oncology using next-generation T-cell engagers (TCEs), today announced dosing of the initial patient in the GUARDIAN-101 phase 1 trial of CLSP-1025, the first tumor-specific TCE to enter clinical development. CLSP-1025 exclusively targets cancer cells expressing the p53R175H mutation, a mutation associated with a wide range of solid tumors, including colorectal, pancreatic, lung, gastric, esophageal, gynecological, and prostate cancers.

Read More

Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025
Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.

In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.

A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

Read More

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Copyright  BioHealth Innovation 2025
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653th Edition, April 22, 2025

By BHI Weekly News Archives

 

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April 22, 2025

NIH Federal Credit Union Expands Support for Members Impacted by Federal RIF, Reinforcing Its “Banking With Heart” Mission”
Since 1940, the NIH Health Federal Credit Union (NIHFCU) has been providing affordable loans and banking solutions to the local biomedical and healthcare communities, including NIH’s civilian workforce and contractors and a lengthy list of other industry employers and organizations in the DMV.

The credit union industry has flourished for well over a century (1909 to be exact) with its “people helping people” philosophy to financial services. Today, while the NIHFCU has expanded its member eligibility requirements beyond the NIH and its affiliates, the recent Reduction in Force (RIF) activities of the federal government will have consequences for many of its members and their families. As NIHFCU has done many times throughout its history (the most recent being the COVID-19 pandemic), it has risen to the occasion to provide for its members who are experiencing direct financial hardship due to the RIF and to live up to the credit union industry’s “people helping people” values.

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2025 Maryland Stem Cell & Regenerative Medicine Tech Showcase Set for April 29
The event, presented by the Maryland Stem Cell Research Fund (MSCRF) and the Maryland Department of Commerce’s Office of Life Science, will spotlight the latest advancements in stem cell research and regenerative medicine technology. Attendees will have the opportunity to listen to elevator pitches from MSCRF’s portfolio companies, each showcasing their unique value proposition to a panel of investors. Additionally, the Showcase will include poster presentations highlighting promising technologies, fostering engagement and dialogue.

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Nikon CeLL Innovation Enters into a Strategic License Agreement with RoosterBio
FREDERICK, Md., April 15, 2025 /PRNewswire/ — Nikon CeLL innovation Co., Ltd. (NCLi), a subsidiary of Nikon Corporation has entered into a strategic licensing agreement with RoosterBio, Inc. (RoosterBio), a leading stem cell technology company in the US.

This agreement provides the Japanese biopharma industry with an end-to-end solution for development and manufacturing of human mesenchymal stem cells (MSC) and extracellular vesicle (EV) therapeutics. Drug developers can leverage RoosterBio’s technology platform to accelerate the development of their advanced therapies with NCLi, and then seamlessly transition to clinical manufacturing within NCLi’s GCTP*1/GMP*2 facility designed specifically for cell therapies.

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GeneDx to Acquire Fabric Genomics, Enabling Decentralized, AI-Powered Testing at Global Scale
GAITHERSBURG, Md. & OAKLAND, Calif.–(BUSINESS WIRE)–GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced its plans to acquire Fabric Genomics, a pioneer in AI-powered genomic interpretation. The transaction enables GeneDx’s leadership in the next phase of genomic medicine: decentralized testing with centralized intelligence.

“Healthcare is at an inflection point where integrating genomic insights into standard care is becoming essential – both for better clinical outcomes and for saving the healthcare system valuable dollars. To achieve this, we must evolve and provide adaptable solutions so this information can be used more proactively and without geographic constraints. Adding Fabric Genomics and their talented team moves us closer to that future, enabling our partners to deliver groundbreaking genomic insights to patients across the globe,” said Katherine Stueland, President and CEO of GeneDx.

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USP – Over half of the active pharmaceutical ingredients (API) for prescription medicines in the U.S. come from India and the European Union
This blog is part of a series on the geographic concentration of pharmaceutical manufacturing. This blog focuses on the manufacturing of active pharmaceutical ingredients (API). For a discussion on finished dose manufacturing, see here .

Historically, U.S. pharmaceutical tariffs have been based on the country where the pharmaceutical API was made.1 Using USP’s Medicine Supply Map, we analyzed the geographic concentration of U.S. prescription API manufacturing, by volume.

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Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025
Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.

In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.

A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

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652nd Edition, April 15, 2025

By BHI Weekly News Archives

 

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April 15, 2025

BHI EIRs Engage at the 2025 Maryland MedTech Summit: A Full-Day Showcase of Innovation and Opportunity
On April 8, 2025, the Maryland MedTech Summit convened nearly 370 leaders from across the medical technology ecosystem at the University of Maryland, College Park, spotlighting the depth and diversity of the region’s growing MedTech community. Held at the Stamp Student Union as the flagship event of the inaugural Maryland MedTech Week, the summit offered a full day of programming, networking, and insights into the future of device innovation. This was the 2nd Annual Maryland MedTech Summit, and the Inaugural Maryland MedTech Week, which also featured investor-focused events hosted by Ecphora Capital, The LaunchPort, and the two-day MedTech Innovator East Coast Road Tour.

BioHealth Innovation, Inc. (BHI) was proud to serve as a sponsor of this year’s summit and sent a strong delegation of Entrepreneurs-in-Residence (EIRs), including Luis Gutiérrez, Albine Martin, Jon Kay, Ray Blanchard, and John Sullivan, all of whom provide strategic commercialization support to MedTech startups and early-stage companies across the BioHealth Capital Region and beyond.

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BHI Joins Regional Leaders at the Inaugural BioConnect Event in North Bethesda
BioHealth Innovation, Inc. (BHI) was proud to join innovators, resource partners, and public officials at the first-ever BioConnect event—a new platform designed to foster collaboration across Montgomery County’s life sciences community. Held at the University of Maryland Institute for Health Computing (UM-IHC) in North Bethesda, the event was co-hosted by Montgomery CountyMCEDC, and UM-IHC, and marks the start of a recurring series aimed at deepening connections between startups, investors, and regional stakeholders.

BHI’s Executives-in-Residence Luis Gutiérrez, and Jennifer Butler attended the event alongside Montgomery County Councilmembers Andrew Friedson and Natali Fani-Gonzalez, offering an opportunity to express appreciation for the County’s continued support of the BHI EIR program and broader innovation infrastructure.

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Now Pre-Leasing: HJF Innovation Labs Set to Launch Fall 2025 in Montgomery County

A new hub for biotech and medical device startups is on the horizon. The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is preparing to open the doors to HJF Innovation Labs in North Bethesda, Maryland, with occupancy beginning Fall 2025.

This first-of-its-kind incubator is tailored to support the development of dual-use medical technologies—those that serve both military and civilian needs. From navigating the complexities of military medical product development to accessing HJF’s expansive research infrastructure and stakeholder network, startups will gain the tools they need to scale innovation and bring critical solutions to market.

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U.Va. hires AstraZeneca exec to lead Manning biotech institute
by Kate Andrews – Mark T. Esser, vice president for vaccines and immune therapies at pharmaceutical giant AstraZeneca, will be the inaugural chief scientific officer and leader of the Paul and Diane  at the , U.Va. announced Thursday.

Esser, who will join U.Va. May 1, earned a Ph.D. in microbiology in 1998 from U.Va.’s medical school, and has worked in translational medicine at AstraZeneca, MedImmune (which was acquired by AstraZeneca) and Merck. He was involved with development of Evusheld, a medicine that helped prevent and treat COVID-19; infection and cancer vaccine programs; human papillomavirus vaccines; and a monoclonal antibody that helps prevent RSV in infants.

The $350 million Manning Institute, launched in 2023 with a $100 million donation from Albemarle County investors Paul and Diane Manning, is a hub for biotech research, development and manufacturing at U.Va., which is building a 350,000-square-foot structure in Fontaine Research Park in  that’s expected to open by late 2026 or early 2027, according to Paul Manning. A member of the university’s board of visitors, Manning founded PBM Products, an infant formula and baby food business, which he sold to Perrigo for an estimated $808 million in 2010. He then started PBM Capital, a private equity firm that invests in pharmaceutical and life sciences startups.

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Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025
Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.

In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.

A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

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TEDCO Invests in Neuros Biotechnology
COLUMBIA, Md., (April 14, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $25,000 Pre-Seed Rural Business Innovation Initiative (RBII) investment in Neuros Biotechnology, Inc. TEDCO’s RBII was designed to enhance technology commercialization and provide technical and business assistance to small and early-stage companies based in rural Maryland.

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AI for Smart Manufacturing: University of Maryland to Host High-Impact Forum on Industrial Productivity

The Maryland Department of Commerce, in collaboration with the University of Maryland, College Park, is hosting the AI for Smart Manufacturing Productivity Forum on Tuesday, May 13, from 1:00 PM to 6:00 PM at A. James Clark Hall.

This half-day event brings together experts, industry leaders, and policymakers to explore how artificial intelligence can transform manufacturing productivity, especially for small and medium-sized enterprises. Highlights include a keynote from Dr. Jay Lee, Director of the Industrial AI Center, and panel discussions featuring leaders from IBMHardwireFraunhofer USA, and more.

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Sixty Degrees Pharma Licenses Yale Patents to Develop Tafenoquine for Babesiosis

WASHINGTON, D.C., April 08, 2025 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees” or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, today announced the signing of a Patent License Agreement with Yale School of Medicine and Yale School of Public Health to jointly advance the development and commercialization of tafenoquine for the treatment and prevention of babesiosis.

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I95 Business: Tammi Thomas: A Driving Force for Growth in Maryland
By Alex Keown – Tammi Thomas is a proponent of agape love, a selfless form of unconditional love that puts the needs of others first. Agape love is not static; it requires demonstrative action, something that drives Thomas in both her personal and professional lives.

“This is the kind of love where you see humanity before you see their differences,” she says.

This mindset is critically important for Thomas, who serves as Chief Development and Marketing Officer at TEDCO (Maryland Technology Development Corporation) headquartered in Columbia. TEDCO supports early-stage technology and life sciences companies in Maryland through resources, connections, and funding opportunities that allow businesses to grow.

In her role, Thomas leads the overall strategic direction, execution, and management of the organization’s marketing and fundraising strategies. Through careful crafting and shaping of TEDCO’s strong brand identity, Thomas says entrepreneurs across the state have learned that the organization is a reliable source for venture capital investments – within the top 20 investors in the Mid-Atlantic region, according to Pitchbook. The constant stitching and storytelling Thomas directs continues to promote scaling and stickiness that brings diverse stakeholders together in a collaborative way.

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651nd Edition, April 8, 2025

By BHI Weekly News Archives

 

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April 08, 2025

Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025
Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.

In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.

A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

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Georgetown Showcases Innovation and Impact at First-Ever Research & Innovation Showcase
On April 1st, Georgetown University celebrated a landmark moment in its growing innovation ecosystem with a full-day dedicated to advancing research, entrepreneurship, and industry collaboration. Hosted by Georgetown’s Office of Technology Commercialization (OTC) in partnership with Georgetown Entrepreneurship, the day’s programming highlighted the university’s commitment to translating bold ideas into real-world solutions.

The day began with the Innovation Awards Luncheon, where outstanding inventors were recognized for their contributions to scientific advancement and commercialization. The Crystal Awards, in particular, honored researchers who are successfully bridging the gap between discovery and application, turning transformative research into real-world impact.

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United Therapeutics Named to ‘100 Best Companies to Work For’ in 2025 by Fortune Media and Great Place to Work
SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that Great Place to Work® and Fortune magazine recognized the company as one of the Fortune 100 Best Companies to Work For® in 2025. United Therapeutics ranked number 73 out of the 100 companies across the nation included in the list.

“We are honored to be recognized by Fortune as one of the 100 Best Companies to Work For,” said Michael Benkowitz, President & Chief Operating Officer of United Therapeutics. “This reflects a key management objective that United Therapeutics be a destination employer, where Unitherians can have their best career while fulfilling our mission to help very sick patients through the development of novel therapeutics and progress toward an unlimited supply of transplantable organs.”

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Vanda Submits New Drug Application to FDA for Bysanti™ to Treat Bipolar I Disorder and Schizophrenia
WASHINGTON, March 31, 2025 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Bysanti™ (milsaperidone) for the treatments of acute bipolar I disorder and schizophrenia. The NDA is supported by several clinical studies assessing the efficacy and safety of Bysanti™.

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IGC Pharma Announces CALMA Phase 2 Trial Expansion with the Addition of MIND Institute
POTOMAC, MD / ACCESS Newswire / April 1, 2025 / IGC Pharma, Inc. (NYSE American:IGC) today announced the expansion of its Phase 2 clinical trial, CALMA, evaluating IGC-AD1 for the treatment of agitation in Alzheimer’s dementia, to MIND Institute at Miami Jewish Health in Miami, Florida. This addition further advances the company’s efforts to accelerate the trial’s completion and builds on promising interim data suggesting the potential of IGC-AD1 to improve patient outcomes.

Miami Jewish Health specializes in healthcare and living options for seniors, providing services for more than 85 years and hosting cutting-edge Alzheimer’s disease clinical trials. The organization is dedicated to advancing research and innovative treatments for neurocognitive disorders, improving care for individuals living with Alzheimer’s and related conditions.

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Quoin Pharmaceuticals Announces Additional Positive ‘Whole Body’ Clinical Data from Ongoing Pediatric Netherton Syndrome Study and Approval to Initiate Testing of a Second Pediatric Patient
ASHBURN, Va., April 02, 2025 (GLOBE NEWSWIRE) — Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late clinical stage, specialty pharmaceutical company focused on the development and commercialization of therapeutic products that treat rare and orphan diseases, today announces additional highly positive clinical data from its ongoing Investigator Pediatric Netherton Syndrome (NS) study. After 6 weeks of continued whole body application of QRX003, the subject’s skin remains almost completely healed demonstrating the durability of ongoing daily treatment with the product. In addition, the patient has continued to have no requirement for previously necessary medications such as antibiotics, antivirals, antihistamines and glucocorticoids. Importantly, with the patient’s pruritus or itch almost completely eliminated, she continues to experience zero nightly sleep disturbances without the need for any sedating medication, marking the first continuous period of uninterrupted sleep in the patient’s life. No adverse events have been reported to date after 6 weeks of whole body treatment with QRX003.

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Boost Your Summer Team with Top Talent: UMD Smith School’s Graduate Internship Program Offers $1,500 Reimbursement Per Intern
This summer, your business can tap into Maryland’s top graduate business talent and get rewarded for it. The Maximizing Maryland Graduate Internship Program, run by the Center for Global Business (CGB) at the Robert H. Smith School of Business, offers companies a $1,500 reimbursement per intern hired—while connecting you with highly skilled students trained in global marketing, supply chain, finance, and business strategy.

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GeneDx Expands Commercial Footprint for Exome and Genome Testing with Inborn Errors of Immunity as a New Indication
GAITHERSBURG, Md.–(BUSINESS WIRE)–GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced the commercial expansion into Inborn Errors of Immunity (IEI), a group of nearly 500 genetic disorders that impair immune function2, increasing susceptibility to infections, autoimmunity, and inflammatory conditions. The strategic expansion reinforces GeneDx’s mission to improve patient outcomes by providing exome and genome testing solutions for an ever-growing number of patients, now including those with inherited immunological conditions.

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