News Archive

In a new video feature, BioHealth Innovation’s Entrepreneur-in-Residence (EIR) Kwame Ulmer offers a candid and experienced take on the evolving FDA landscape and its impact on medical device innovation.

As Managing Partner at MedTech Impact Partners, Kwame brings more than two decades of regulatory expertise to the table. His experience includes twelve years in leadership roles at the FDA, culminating as Deputy Director and Branch Chief, where he personally evaluated over 1,000 medical technologies. Today, he advises startups on regulatory strategy, supports complex submissions including de novo, PMA, and 510(k), and helps medtech founders navigate an increasingly uncertain regulatory environment.

UVA Health has received two anonymous $25 million estate gifts to support the University of Virginia’s Paul and Diane Manning Institute of Biotechnology. The $50 million of additional support for the institute enabled UVA Health to top its $1 billion fundraising goal in UVA’s Honor the Future campaign, which concludes this month. 

“I’m deeply grateful for the generosity and vision of these donors, whose contributions will help us to realize the full potential of the Manning Institute, and for everyone who has helped UVA Health reach this milestone,” said UVA President Jim Ryan. “These extraordinary gifts will support the Manning Institute’s research and aid in developing new treatments for hard-to-treat or incurable diseases, which will change lives across the Commonwealth and beyond.”

ROCKVILLE, Md. & EDMONTON, Alberta–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced positive results from a Phase 1 single-ascending-dose (SAD) study of aritinercept (AUR200), its dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL). The study investigated aritinercept doses of 5 mg, 25 mg, 75 mg, 150 mg, 225 mg and 300 mg and placebo, administered by subcutaneous injection, in 61 healthy subjects.

Applications are now open for the 9th Annual Crab Trap Competition, one of the signature events of BioHealth Capital Region Week 2025, taking place on Wednesday, September 24, during Day 2 of the BioHealth Capital Region Forum at US Pharmacopeia (USP) in Rockville, Maryland.

The Crab Trap showcases emerging startups developing high-impact innovations in therapeutics, diagnostics, medical devices, digital health, and other transformative areas of healthcare. Finalists will pitch live to a panel of expert judges in front of a high-profile audience of industry leaders, investors, and commercialization partners.

The winning company will receive a valuable package of services and recognition to help accelerate its growth.

Click here to apply to compete in the Crab Trap.

Deadline to apply: AUGUST 29, 2025

ROCKVILLE, Md., June 26, 2025 (GLOBE NEWSWIRE) — I-Mab (NASDAQ: IMAB) (the “Company”), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced publication of ESMO Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) abstract #388MO related to positive data from a Phase 1b study evaluating givastomig in combination with nivolumab and mFOLFOX6 chemotherapy for metastatic gastric cancers. An objective response rate (ORR) of 71% (12/17) was observed across all dose levels with an ORR of 83% (10/12) observed at dose levels selected for the ongoing dose expansion study (8 and 12 mg/kg). Responses were rapid and deepened over time, and were observed in tumors with low levels of PD-L1 expression and/or low levels of Claudin 18.2 (CLDN18.2) expression. There was a favorable safety profile, with low incidence of GI and liver toxicities. I-Mab intends to host a virtual investor event on Tuesday, July 8^th (register here) to recap the data being presented at ESMO GI.

GAITHERSBURG, Md., June 26, 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 positive topline results from the IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH).

GAITHERSBURG, Md., June 23, 2025 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced it has been awarded a $62.4 million contract modification from the Administration for Strategic Preparedness and Response (ASPR), a division of the United States Department of Health and Human Services (HHS) for BAT^® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)]. The modification has been made to the existing 10-year contract with ASPR (75A50119C00075) whereby Emergent will supply BAT^®, an antitoxin used in the treatment of symptomatic botulism following suspected or confirmed exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in both adults and pediatric patients.

The 2025 BIO International Convention brought together over 20,000 life sciences leaders from across the globe. BioHealth Innovation, Inc. (BHI), led by Founder, President, and CEO Rich Bendis, was proud to represent both the organization and the broader BioHealth Capital Region (BHCR) during this year’s gathering in Boston.

As one of the most wide-ranging events in the biotech industry, BIO 2025 served as a platform to showcase the BioHealth Capital Region’s unique strengths. The region, encompassing Maryland, Washington, D.C., and Virginia, presented a united front of innovation and economic vitality. Maryland and Virginia each hosted pavilions that attracted strong traffic and engagement, while the District’s leadership was prominently involved in cross-jurisdiction conversations.

“There was a great deal of interaction between the members of the BHCR during the Convention and it culminated with the First Annual BHCR Breakfast on Wednesday the 18th,” said Bendis. “Virginia also had their own breakfast on Tuesday the 17th and Maryland had a well-attended evening reception that same day. These events made it clear just how committed the region is to growing together.”

The BioHealth Capital Region BIO Breakfast, hosted at Maryland Tech Council Member, Vertex Pharmaceuticals. The breakfast brought together stakeholders from all three jurisdictions, reaffirming a shared commitment to growing the region’s life sciences economy. The breakfast was headlined by a panel discussion including Harry Coker, Jr, Secretary, Maryland Department of Commerce; Derek Ford, President & CEO, Washington DC Economic Partnership; Rachel Rath, Head of JLABs @ Washington D.C., and Joe Benevento, CEO, Virginia Innovation Partnership Corporation. BHI’s Rich Bendis served as the moderator for this panel.

As DNA research enters a critical stage in next-generation sequencing, better methods are needed to visualize and study molecules.

Evizia, a company founded and based on technology developed by Jason Reed, Ph.D., a physics professor in the Virginia Commonwealth University College of Humanities and Sciences, has landed a $2.2 million grant from the National Human Genome Research Institute at the National Institutes of Health.

The “Direct to Phase II” Small Business Innovation Research grant will help Evizia optimize the manufacturing of its advanced microscope system that can benefit researchers with its novel method to visualize and study DNA molecules. Reed says the platform increases the quality of next-generation DNA sequencing and will support the development of new diagnostics and therapeutics.