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660th Edition, June 10, 2025

By BHI Weekly Newsletter Archives
 

Decoding Federal Dollars: Grant Engine CEO Sam Tetlow on the Evolving Biohealth Funding Map on BioTalk

In this episode of BioTalk, Sam Tetlow, Founder and CEO of Grant Engine, joins the conversation to share insights on how early-stage biotech and life science companies can navigate today’s complex federal funding environment. With a career spanning entrepreneurship, investment, and grant strategy, Sam breaks down what’s changed under the current administration, how companies should position themselves for success, and the durable tactics that still matter in securing SBIRs, ARPA-H contracts, and other non-dilutive awards. He also discusses the evolving priorities at HHS, the role of program officers, and how Grant Engine is adapting to help clients align with shifting agency goals. This episode builds on the upcoming June 10th, 2025 webinar co-hosted by Sam and BioHealth Innovation’s Rich Bendis, “Turning Uncertainty to Opportunity: Mastering Government Funding in 2025.” Learn more and register at: https://info.grantengine.com/turning-uncertainty-into-opportunity-mastering-government-funding-in-2025

Listen via your favorite podcast platform:
Apple – https://apple.co/4jEWGWO
Spotify – https://spoti.fi/3HIa5Qx
iHeart – https://ihr.fm/4dWwB4y
Amazon – https://amzn.to/4jELdqn
YouTube – https://bit.ly/3HHIwqA
TuneIn –  https://bit.ly/2M60Wmx

 

Read More

 
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.

Read More

 

USP announces new Advanced Technologies Laboratory in Maryland to accelerate and scale pharmaceutical manufacturing innovations

Lab will help enable broader adoption of advanced manufacturing technologies and state-of-the-art quality solutions 

Rockville, MD – June 4, 2025 – The U.S. Pharmacopeia (USP) announced today the opening of its Advanced Technologies Laboratory in Rockville, Maryland. USP will use this lab, and related solutions and expertise, to develop, pilot, and scale innovations that foster more efficient and expanded production of quality medicines for stronger and more secure supply chains. 

The lab expands USP capabilities to help manufacturers overcome barriers in the adoption of advanced manufacturing technologies by developing new approaches and processes for flow chemistry and additive manufacturing coupled with advanced analytical techniques such as process analytical technologies (PAT) that can enable real-time quality monitoring. The lab will also support development of alternative and novel synthetic routes to produce active pharmaceutical ingredients (APIs) and key starting materials. Taken together, these capabilities are essential in efforts to create stronger supply chains through strategic onshoring, distributed manufacturing, and personalized medicine. 

Read More

 
Previous BHCR Crab Trap Winner Luminoah Selected for Prestigious MedTech Innovator 2025 Accelerator Cohort

Charlottesville, VA – June 5, 2025 – Luminoah, a medical device company transforming chronic disease care through personalized enteral nutrition delivery, announced today that it has been selected to join the MedTech Innovator 2025 Accelerator Cohort. Luminoah is one of only 65 companies—representing the top 4% of nearly 1,500 global applicants—chosen for this year’s program.

MedTech Innovator (MTI) is the world’s largest accelerator for medical technology startups. The highly competitive four-month program provides participants with world-class mentorship, strategic guidance, and access to a robust network of investors, providers, payers, manufacturers, and industry experts.

“We are honored to join this year’s MedTech Innovator cohort,” said Neal Piper, Founder and CEO of Luminoah. “This opportunity gives us a powerful platform to validate our technology, accelerate key partnerships, and expand the reach of our mission to set a new standard in enteral nutrition.”

Read More

 

GlycoMimetics Stockholders Approve Proposed Merger with Crescent Biopharma and All Related Proposals

ROCKVILLE, Md.–(BUSINESS WIRE)–GlycoMimetics, Inc. (Nasdaq: GLYC) (“GlycoMimetics”) today announced that its stockholders have approved the proposed merger (the “Merger”) with Crescent Biopharma, Inc. (“Crescent”), along with all proposals related to the Merger. The proposals were voted upon at GlycoMimetics’ special meeting in lieu of the annual meeting of stockholders held on June 5, 2025 (the “Special Meeting”), including a reverse stock split of GlycoMimetics’ common stock to be effected at the discretion of the board of directors of GlycoMimetics (the “Board”) within the parameters approved by GlycoMimetics’ stockholders.

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Maryland Stem Cell Research Fund Announces Call for Applications for the July 2025 Cycle

COLUMBIA, Md., June 4, 2025 /PRNewswire/ — The Maryland Stem Cell Research Commission (“Commission“) is pleased to announce the release of Requests for Applications (RFAs) for the July 2025 funding cycle. The deadline for application submissions is July 9, 2025.

The upcoming cycle supports a broad spectrum of grant programs, including early-stage basic research, translational efforts, clinical trials and manufacturing support. Maryland-based academic institutions, nonprofits and companies are encouraged to apply. Additionally, companies/non-profit entities outside Maryland are eligible to apply, provided the funded research occurs within the state. Supplemental funding is available for research projects involving collaboration between public and private sectors, accelerating the development of therapies for unmet medical needs.

Read More

 

IonQ Speeds Quantum-Accelerated Drug Development Application With AstraZeneca, AWS, and NVIDIA

COLLEGE PARK, Md.–(BUSINESS WIRE)–IonQ (NYSE: IONQ), a leading commercial quantum computing and networking company, announced results of a collaborative research program between IonQ, AstraZeneca, Amazon Web Services (AWS), and NVIDIA to develop and demonstrate a quantum-accelerated computational chemistry workflow which has the potential to power world-changing innovation in healthcare, life sciences, chemistry, and more.

Read More

 
NIH OTT’s Tara Kirby Selected as IAM Market Maker

The NIH Office of Technology Transfer Director, Dr. Tara Kirby, has been recognized by Intellectual Asset Management (IAM) as a Market Maker of the year. IAM’s Market Makers recognizes the top 40 key deal makers and decision takers in the world, as selected by the IAM editorial team. They consider who has driven major asset transactions, who has worked tirelessly to innovate in the dealmaking space and have engineered value from intellectual property.

Dr. Kirby was selected as #7 out of the list of 40 Market Makers. Included below is an excerpt from IAM’s article:

Read More

 

REGENXBIO Shares Promising Early Results from Gene Therapy Trial for Duchenne Muscular Dystrophy

ROCKVILLE, Md., June 5, 2025 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced new positive interim data from the Phase I/II AFFINITY DUCHENNE trial. Updates include positive functional, safety and biomarker data for RGX-202, REGENXBIO’s potential best-in-class, investigational gene therapy for Duchenne muscular dystrophy. The functional data demonstrate consistent benefit among dose level 2 participants at 9 and 12 months following treatment with RGX-202.

Read More

 
IonQ Completes Acquisition of Lightsynq, Accelerating Quantum Computing and Networking Roadmap

COLLEGE PARK, MD – June 3, 2025 – IonQ (NYSE: IONQ), a leading commercial quantum computing and networking company, today announced the successful completion of its acquisition of Lightsynq Technologies, Inc., a Boston-based startup specializing in photonic interconnects and quantum memory. This strategic acquisition accelerates IonQ’s fault-tolerant quantum computing roadmap and advances progress toward the development of the quantum internet.

Lightsynq’s photonic interconnect platform supports high-fidelity, multi-nodal qubit operations and modularity, which are essential for scaling quantum computers. The company’s innovations in quantum memory and repeater technology complement IonQ’s trapped-ion quantum computing approach and will advance IonQ’s quantum networking systems.

Read More

 

MacroGenics and Sagard Healthcare Partners Enter into ZYNYZ® Royalty Purchase Agreement

ROCKVILLE, MD, June 10, 2025 (GLOBE NEWSWIRE) — MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced that it has entered into a royalty purchase agreement with Sagard in exchange for a capped royalty interest on future global net sales of ZYNYZ (retifanlimab-dlwr). ZYNYZ is a PD-1 inhibitor originally developed by MacroGenics and licensed to Incyte pursuant to an exclusive global collaboration and license agreement in October 2017. MacroGenics retains its other economic interests related to ZYNYZ, including future potential development, regulatory and commercial milestones. MacroGenics will also continue to support a portion of global commercial manufacturing needs for ZYNYZ.

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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.

 
 

 

659th Edition, June 3, 2025

By BHI Weekly Newsletter Archives

 

Trouble Viewing This Email: Click Here

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

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.”

Read More

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).

Read More

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.

Read More

 

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.

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.

 

659th Edition, June 3, 2025

By BHI Weekly Newsletter Archives

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

Read More

 
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.

Read More

 

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.

Read More

 
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.

Read More

 

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.

Read More

 
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.

Read More

 

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.

Read More

 
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.”

Read More

 

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).

Read More

 
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.

Read More

 
 

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.

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.

 
 

 

658th Edition, May 28, 2025

By BHI Weekly Newsletter Archives

 

Trouble Viewing This Email: Click Here

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.”

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

 

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.

Read More

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.

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.

 

658th Edition, May 28, 2025

By BHI Weekly Newsletter Archives

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.”

Read More

 
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.

Read More

 

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.

Read More

 
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.

Read More

 

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.

Read More

 
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.

Read More

 
 

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.

Read More

 
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.

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.

 
 

 

657th Edition, May 20, 2025

By BHI Weekly Newsletter Archives

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

 

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

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 
 

 

657th Edition, May 20, 2025

By BHI Weekly Newsletter Archives

 

Trouble Viewing This Email: Click Here

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.

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

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

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 

BioHealth Innovation Weekly for May 20, 2025

By BHI Weekly Newsletter Archives

 

 

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.

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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.

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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.

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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.

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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

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656th Edition, May 13, 2025

By BHI Weekly Newsletter Archives

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

Read More

 
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

Read More

 
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.”

Read More

 

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.

Read More

 

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.

Read More

 
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.

Read More

 

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.

 
 

 

656th Edition, May 12, 2025

By BHI Weekly Newsletter 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

Read More

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

Read More

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.”

Read More

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.

Read More

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.

Read More

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.

Read More

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.

 

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