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BHI Weekly News Archives

657th Edition, May 20, 2025

By BHI Weekly News Archives

 

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May 20, 2025

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

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 News 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.

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.

 

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656th Edition, May 13, 2025

By BHI Weekly News 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 News Archives

 

Trouble Viewing This Email: Click Here

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.

 

655th Edition, May 6, 2025

By BHI Weekly News Archives
 

Beyond the Device: Neopenda’s Human-Centered Approach to Health Tech

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

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

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

Read More

 
Successful 2nd Annual “Stem Cell and Regenerative Medicine Tech Showcase” Held on April 29, 2025

Innovators in Regenerative Medicine Gathered to Drive Healing and Hope

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

Read More

 

Emergent BioSolutions Announces Agreement to Supply the Ontario Ministry of Health with NARCAN®

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

Read More

 
RoosterBio Announces Collaboration with Thermo Fisher Scientific to Advance Cell and Exosome Therapy Manufacturing

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

Read More

 

VerImmune Awarded ~$470K CDMRP Grant to Drive Innovation in ViP-Based Therapeutics for Advanced Melanoma

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

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

Read More

 

UMSOM: New Innovation Alliance Aims to Drive New Med Tech Ventures In Region

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

Read More

 
PQE Group US Earns Great Place to Work Certification™

Over $1 million awarded to 7 university projects 

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

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

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

Read More

 

BioHealth at a Crossroads: Alex Philippidis on Policy Shifts, Investment Trends, and What’s Ahead on BioTalk

In this timely episode of BioTalk, returning guest Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News, joins host Rich Bendis to explore how sweeping changes in U.S. regulatory policy, workforce dynamics, and economic pressures are affecting the biotech industry in real time.

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

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

Read More

 

Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025

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

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

A Call for Sponsors

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

Read More

 

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

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 
 

 

655th Edition, May 6, 2025

By BHI Weekly News Archives

 

Trouble Viewing This Email: Click Here

May 6, 2025

 

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

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

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

Read More

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

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

Read More

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

Read More

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

Read More

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

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

Read More

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

Read More

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

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

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

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

Read More

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

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

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

Read More

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

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

A Call for Sponsors

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

Read More

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

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 

654th Edition, April 29, 2025

By BHI Weekly News Archives

BioHealth at a Crossroads: Alex Philippidis on Policy Shifts, Investment Trends, and What’s Ahead on BioTalk

In this timely episode of BioTalk, returning guest Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News, joins host Rich Bendis to explore how sweeping changes in U.S. regulatory policy, workforce dynamics, and economic pressures are affecting the biotech industry in real time.

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

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

Read More

 
Phlow Corp. Expands Analytical Capabilities and Embraces Artificial Intelligence-Driven System, Ushering in a New Era of Modern Medicine Manufacturing in America

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

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

Read More

 
Lending a Helping Hand: the National Institutes of Health Federal Credit Union

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

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

Read More

 

Sonavex Receives FDA 510(k) Clearance for EchoMap™ Device

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

Read More

 

Welldoc Certified as a Great Place to Work® for Fourth Consecutive Year

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

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

Read More

 
Carr Tech Corp Celebrates FDA 510(k) Class II Approval of FROG All-in-One Filter Needle

This transformative device advances safety and efficiency in drug preparation, underscoring the startup’s journey from solo founder to FDA-cleared innovator.

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

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

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

Read More

 

Precision for Medicine and PathAI Announce Strategic Collaboration to Advance AI-Powered Clinical Trial Services and Biospecimen Products

Collaboration will deliver innovative AI-powered pathology tools and quality control enhancements to accelerate clinical trials and biomarker discovery

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

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

Read More

 
TEDCO’s Maryland Innovation Initiative Announces FY2025 Technology Assessment Awards

Over $1 million awarded to 7 university projects 

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

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

Read More

 
Digitalis Commons – Notes on Catalyzing Health & Changes in the Scientific Stack

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

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

Read More

 

Compremium AG Appoints Dr. Kolaleh Eskandanian to Lead New Division of Pediatrics and Special Populations

Swiss MedTech leader taps renowned pediatric innovation expert to serve as Chief Strategy and Innovation Officer and Head of Pediatrics

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

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

Read More

 
BizJournals: Phlow touts expansion, investment in Richmond and Petersburg

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

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

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

Read More

 
 

Clasp Therapeutics Begins First Human Trial of New Immune Therapy Designed to Precisely Attack Cancer Cells

Clasp Therapeutics Doses First Patient in Phase 1 Clinical Trial With a First-in-Class T-Cell Engager Designed to Target Cancer Cells With Absolute Specificity

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

Read More

 
Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025

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

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

A Call for Sponsors

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

Read More

 

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

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 
 

 

654th Edition, April 29, 2025

By BHI Weekly News Archives

 

Trouble Viewing This Email: Click Here

April 29, 2025

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

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

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

Read More

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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.

 

653th Edition, April 22, 2025

By BHI Weekly News Archives

 

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April 22, 2025

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

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

Read More

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

Read More

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

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

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

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

Read More

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

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

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.

 

653rd Edition, April 22, 2025

By BHI Weekly News Archives

NIH Federal Credit Union Expands Support for Members Impacted by Federal RIF, Reinforcing Its “Banking With Heart” Mission”

Since 1940, the NIH Health Federal Credit Union (NIHFCU) has been providing affordable loans and banking solutions to the local biomedical and healthcare communities, including NIH’s civilian workforce and contractors and a lengthy list of other industry employers and organizations in the DMV.

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

Read More

 
2025 Maryland Stem Cell & Regenerative Medicine Tech Showcase Set for April 29

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

Read More

 

Nikon CeLL Innovation Enters into a Strategic License Agreement with RoosterBio

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

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

Read More

 

GeneDx to Acquire Fabric Genomics, Enabling Decentralized, AI-Powered Testing at Global Scale

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

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

Read More

 

USP – Over half of the active pharmaceutical ingredients (API) for prescription medicines in the U.S. come from India and the European Union

This blog is part of a series on the geographic concentration of pharmaceutical manufacturing. This blog focuses on the manufacturing of active pharmaceutical ingredients (API). For a discussion on finished dose manufacturing, see here .

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

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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