NORTH CHICAGO, Ill. and ROCKVILLE, Md., Jan. 13, 2025 /PRNewswire/ — AbbVie (NYSE: ABBV) and REGENXBIO Inc. (Nasdaq: RGNX) today announced updates to the ABBV-RGX-314 clinical program.

ABBV-RGX-314 in Wet Age-Related Macular Degeneration (wet AMD), Subretinal Delivery
Data from the ATMOSPHERE^® and ASCENT^™ pivotal trials evaluating the safety and efficacy of the subretinal delivery of ABBV-RGX-314 in patients with wet AMD are expected in 2026.

ABBV-RGX-314 in Diabetic Retinopathy (DR), Suprachoroidal Delivery
AbbVie and REGENXBIO will plan a Phase 3 clinical program. The clinical program will utilize the in-office SCS Microinjector^® to deliver gene therapy to the suprachoroidal space of the eye.

January 13, 2025 – By Ruxandra Draghia-Akli, MD, PhD, Executive Vice President, Head of R&D and Elaine O’Hara, Executive Vice President, Chief Strategy Officer

As we enter the new year, Novavax is embarking on an ambitious new corporate growth strategy to maximize the impact of our cutting-edge technology. We are focused on forging strategic partnerships for both our early- and late-stage research and development (R&D) assets and our Matrix-M™ adjuvant with the goal of driving vaccine innovation that protects the health of people.

Our Innovative Technology Platform

Novavax’s technology platform combined with our deep vaccine expertise is the fuel for future innovation and partnerships. The unique platform features two key elements:

• Recombinant protein-based nanoparticle: This technology enhances immune recognition by presenting multiple copies of viral antigens on the surface of each nanoparticle. Antigens displayed in this manner tend to lead to greater stimulation of the immune system, resulting in a more efficacious vaccine.^1-3
• Matrix-M™ adjuvant: Our proprietary adjuvant works together with the nanoparticle to induce potent, durable and broad immune responses, with the potential to be antigen-sparing.^4-7 Matrix-M increases both antibody and cell-mediated immune responses to the vaccine, and has demonstrated a favorable tolerability and safety profile in clinical trials across a variety of different antigens.⁷ Matrix-M is used in our authorized COVID-19 vaccine and the R21/Matrix-M malaria vaccine.

Like his fellow Type 1 diabetics, Alec Smith took insulin every day to regulate his blood sugar. Costs to treat his condition topped $1,000 per month, most of that going to insulin, and Alec made the difficult decision to ration his insulin to save money after aging off his mother’s health insurance plan.

Rationing insulin is a delicate process for diabetics. The body’s insulin needs can fluctuate significantly due to changes in diet, exercise, stress, poor sleep, or other medications, and diabetics must constantly monitor their glucose levels even when taking insulin as directed. When a person’s blood sugar gets too high, the body goes into diabetic ketoacidosis, which releases dangerous amounts of acid into the bloodstream and, if left untreated, can result in death — as it unfortunately did for Alec Smith in 2017. His mother, Nicole Smith-Holt, told CBS News, “I think if the price of insulin in 2017 had been $35, Alec would still be alive today.”

ROCKVILLE, Md., Jan. 7, 2025 /PRNewswire/ — Essex Management, an Emmes Group company and a leader in biomedical informatics and health information technology, is pleased to announce the appointment of David Loose as Chief Executive Officer (CEO), effective immediately. David succeeds Kevin Hurley, who has served as CEO since February 2019 and will transition to the role of Executive Advisor.

David Loose joined Essex Management as a partner in February 2009 and has played a pivotal role in the company’s growth. Starting as Vice President for Business Operations and Development, he later served as Chief Business Officer, overseeing critical operations, driving client-focused innovation, and delivering strategic initiatives such as NCI’s Clinical Trials Reporting Program (CTRP). His leadership and dedication to Essex’s mission have been instrumental in building its reputation as a trusted partner in the biomedical and health technology sectors.

“David’s leadership and dedication to Essex’s mission make him the ideal choice to guide the company forward,” said Sastry Chilukuri, CEO of Emmes Group. “His focus on innovation and client success will ensure Essex continues to deliver transformative solutions in biomedical informatics and health IT.”

*NOTE: Solution Summary due: February 14, 2025
 

The Big Question  

What if we could end the rare disease diagnostic odyssey?

The Problem  

Collectively, rare diseases are far from rare — more than 10,000 unique conditions affect over 350 million people worldwide, including one in ten Americans. The lengthy diagnostic “odyssey” endured by patients with a rare disease lasts six years on average but can extend for decades. Diagnostic delays stem from multiple factors, including overlapping symptoms, low disease incidence, and limited specialist expertise. It’s estimated that half of all individuals with a rare disease remain undiagnosed or misdiagnosed, leading to inappropriate care, irreversible disease progression, and rising medical costs.  

BHI is excited to highlight Rachel Rath’s recent LinkedIn Post, where she reflects on her first 90 days as Head of JLABS @ Washington, DC. Rachel, who recently joined the BHI Board of Directors, discusses the Mid-Atlantic’s strengths—including its talent pool, investor activity, and opportunities for deeper collaboration.

We look forward to continuing to work with Rachel and JLABS to drive growth and innovation in the BioHealth Capital Region.

90 Days In: Reflections on an Evolving Life Science Landscape in the Mid-Atlantic

December 30, 2024

The views and opinions expressed in this article are those of the author.

Time flies when you’re having fun! My first 90 days as Head of JLABS @ Washington, DC (JLABS DC) have been both energizing and eye-opening. While I’ve spent nearly 20 years in the DMV (DC-Maryland-Virginia), been part of Johnson & Johnson and the JLABS team for 5 years, and been based at JLABS DC since the site opened, it’s been fulfilling to move from a global role into a role that allows me to deep-dive into the local ecosystem that I call home. The DMV region and broader Mid-Atlantic region boast incredible strengths, but these first few months in the job have underscored the work that remains to unlock the region’s full potential. Here are three reflections as I recognize the strengths of this region and look at how JLABS DC can continue to help spur the region’s trajectory:

DEC 20, ANNAPOLIS, MD — Governor Wes Moore today signed an executive order to strengthen Maryland’s business climate and catalyze more economic growth in the state. The governor signed the order during a visit to the Frederick Hotel and Conference Center project site in Frederick—a public-private development project that is expected to generate $1.5 billion in new private sector spending over the next 25 years, more than 200 jobs, and more than $4 million in state and local tax revenue annually. 

ROCKVILLE, MD, Jan. 6, 2025 /PRNewswire/ — 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 highlighted its strategic outlook for 2025 and a re-prioritization of resources, with a focus on advancing its lead program, givastomig, a CLDN18.2 x 4-1BB bispecific antibody, targeting first-line metastatic gastric cancers, with further potential in other solid tumors.

Italy, December 23, 2024. PQE Group is proud to announce its most recently-received official recognitions: ISO/IEC 27001 and A Women’s Business Enterprise (WBE) Certifications, which provide additional reasons to recognize PQE Group’s extensive capabilities; the ISO/IEC 27001 provides clients assurance that their information management systems are risk-aware and that PQE Group’s solutions can proactively identify and address weaknesses; the WBE Certification ensures that PQE Group has met the stringent eligibility criteria to be classified as a women-owned enterprise.

WASHINGTON, Dec. 11, 2024 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (60 Degrees Pharmaceuticals or the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today it has entered into a clinical trial agreement with Brigham and Women’s Hospital (BWH) in Boston to conduct a double-blind, placebo-controlled study evaluating the safety and efficacy of tafenoquine in combination with standard of care treatment for hospitalized babesiosis patients.

GAITHERSBURG, Md., Dec. 13, 2024 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced progress in Q4 2024 advancing its corporate growth strategy through its partnership with Sanofi. The Company has achieved a milestone associated with its Phase 2/3 clinical trial for its COVID-19 vaccine in children, triggering the first $50 million milestone payment from Sanofi.

The National Cancer Institute (NCI) Technology Transfer Center is hosting a webinar on an exciting new technology that could revolutionize MRI metabolic imaging. Scheduled for Wednesday, December 18, 2024, at 11:00 AM ET, this free webinar will introduce a novel Signal Amplification By Reversible Exchange (SABRE) catalyst technology, co-developed by the National Heart, Lung, and Blood Institute (NHLBI) and NCI. This innovation promises to enhance MRI imaging capabilities, enabling groundbreaking advancements in the detection and monitoring of cancer, cardiovascular disease, stroke, and traumatic brain injury. 

ANNAPOLIS, Md., Dec. 10, 2024 /PRNewswire/ —  Alphyn, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^®, announced today that the U.S. Patent and Trademark Office (USPTO) has granted the company a patent covering compositions and methods of use for the drug formulation of Zabalafin Hydrogel (AB-101a) for atopic dermatitis (AD). The patent covers Zabalafin Hydrogel through 2042 and is eligible for listing in the U.S. Food and Drug Administration’s (FDA) Orange Book, which provides additional protective benefits once Zabalafin Hydrogel receives FDA approval.

Multiplexed, extraction-free, full-length library preparation technology facilitates large-scale RNA sequencing, combining ever more content with high throughput

FREDERICK, Md., Dec. 9, 2024 /PRNewswire-PRWeb/ — Alithea Genomics, a leader in the field of large-scale RNA sequencing and transcriptomics, announced today the launch of MERCURIUS™ Full-Length DRUG-seq library preparation technology, which combines, for the first time, massive sample multiplexing, an extraction-free workflow and full transcript coverage in a unique RNA-seq workflow. The technology is compatible with both 96- and 384-well plate formats and up-to 384 full-length RNA-seq library preps can be performed in a single tube without RNA isolation.

MSCRF invites applications across seven key grant programs to propel innovation in regenerative medicine

COLUMBIA, Md. (November 14, 2024) – The Maryland Stem Cell Research Commission (MSCRC) announces the release of a Request for Applications (RFA) for the Maryland Stem Cell Research Fund’s (MSCRF) second funding cycle of Fiscal Year 2025 (FY25). This funding opportunity spans seven diverse grant programs: Manufacturing Assistance, Clinical, Validation, Commercialization, Discovery, Fellowship and Launch. The application deadline is January 13, 2025.

MSCRF grants support both young and established scientists, companies and research organizations to accelerate and advance the commercialization of innovative stem cell technologies for positive impact on human lives. 

FREDERICK, Md., Dec. 03, 2024 (GLOBE NEWSWIRE) — Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced updated efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with generalized myasthenia gravis (MG) and provided details on the design of its planned Phase 3 AURORA trial. The updated data will be presented today at the 2^nd Annual Cell Therapy for Autoimmune Disease Summit being held in Philadelphia.

There are several keys to successful entrepreneurship—a great idea that solves a unique problem, the willingness to take risks, leadership skills, networking, and, of course, capital. The last element listed can be especially challenging for those without significant savings, investment from wealthy family members, or generational wealth, says Graham Dodge, vice president, Venture Development at TEDCO, (Maryland Technology Development Corporation), an independent instrumentality of the State of Maryland to facilitate the creation of businesses and support their growth in all regions of the State.

Firm Remains Focused on Partnering with Healthcare Business Owners on Control Growth Transactions

WASHINGTON, Nov. 20, 2024 /PRNewswire-PRWeb/ — NaviMed Capital, a Washington, DC-based private equity firm focused exclusively on the healthcare industry, today announced the closing of its third fund, NaviMed Partners III (“Fund III”). The substantially oversubscribed new fund closed at its hard cap of $450 million of commitments. With the new fund, NaviMed now manages more than $850 million of capital commitments.

NaviMed will continue to focus on control investments in fast growing lower middle-market healthcare companies. The firm specializes in acquiring businesses that provide business process outsourcing services to hospitals and other healthcare providers, health insurers, and the pharmaceutical and medical device industries. NaviMed seeks to invest in profitable private companies with up to $10 million of EBITDA and double-digit annual revenue growth.

The Biomedical Advanced Research and Development Authority (BARDA) has announced the launch of the SPARK Hub Prize Challenge, offering up to $50,000 in funding to innovators working on medical countermeasures (MCMs) designed specifically for children. The challenge supports technologies and products that enhance health security for pediatric populations and is open for submissions until December 16, 2024. https://www.mcm4kids.org/funding/

About BARDA and the Challenge
BARDA plays a pivotal role in safeguarding public health by advancing the development of MCMs for various health security threats, including chemical, biological, radiological, and nuclear (CBRN) hazards, pandemic influenza, and emerging infectious diseases. The SPARK Hub Prize Challenge is an extension of this mission, focusing on solutions tailored to pediatric needs. BARDA’s aim is to ensure that medical countermeasures are accessible to all segments of the population, including children, who have unique requirements during public health emergencies.

MSCRF invites applications across seven key grant programs to propel innovation in regenerative medicine

COLUMBIA, Md. (November 14, 2024) – The Maryland Stem Cell Research Commission (MSCRC) announces the release of a Request for Applications (RFA) for the Maryland Stem Cell Research Fund’s (MSCRF) second funding cycle of Fiscal Year 2025 (FY25). This funding opportunity spans seven diverse grant programs: Manufacturing Assistance, Clinical, Validation, Commercialization, Discovery, Fellowship and Launch. The application deadline is January 13, 2025.

MSCRF grants support both young and established scientists, companies and research organizations to accelerate and advance the commercialization of innovative stem cell technologies for positive impact on human lives. 

COLUMBIA, Md., (November 12, 2024) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 Seed Funds investment in NextStep Robotics. TEDCO’s Seed Funds aim to reach prospective businesses showing potential of being venture fundable or other forms of corporate venture, such as follow-on funding.

“Foot drop is a disability that results from underlying neurological or muscular injuries and affects millions of Americans each year,” said Bradley Hennessie, CEO of NextStep Robotics. “With traditional treatments, patients were left with uncomfortable orthotics or assistive devices. However, with this latest investment from TEDCO, we are excited to continue moving forward to provide more appealing solutions and support patients and physical therapists alike.”

WASHINGTON, D.C., (November 14, 2024) – Johnson & Johnson (NYSE: JNJ) today announced results from additional analyses of the Phase 2 DAHLIAS study highlighting improvement in key measures of disease activity and significant IgG reduction by over 77% following treatment with investigational nipocalimab in adult patients with moderate-to-severe Sjögren’s disease (SjD). These data were included in a plenary session presentation (Abstract #2527) and two posters (Abstracts #1427 and #2294) and are among the Company’s 43 oral and poster presentations at the American College of Rheumatology (ACR) Convergence 2024.

LONDON, Nov. 12, 2024 /PRNewswire/ — Ascend Advanced Therapies (Ascend), a gene-to-GMP development partner, has partnered with EW Healthcare Partners to expand the footprint and capabilities of the company in the US and to continue investing further in infrastructure. Advanced BioScience Laboratories (ABL), a biotherapy, oncolytic and viral vector contract development, and manufacturing organization (CDMO) located in Rockville, MD, a portfolio company of EW Healthcare Partners, will become part of Ascend. EW will also make a significant capital investment in Ascend to support continued growth of the company.

The NIH Office of Technology Transfer is recruiting for a Deputy Director (GS-15 level) to lead its License Compliance and Administration Unit. This critical role involves managing NIH’s large and diverse invention license portfolio.

Position Details:
Title: Supervisory Technology Transfer Specialist (GS 601-15)
Location: Montgomery County, MD
Open Date: Monday, November 18, 2024
Close Date: Friday, November 22, 2024

This is an All-Sources announcement with two application pathways:
? Current or former USG employees: https://lnkd.in/eYJuHMpV
? U.S. citizens: https://lnkd.in/etYHqykM

Don’t miss this chance to join a dynamic team and make an impact on technology transfer at NIH!

GAITHERSBURG, Md., Nov. 07, 2024 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) and agreement on the design of a Phase 3 registrational program for its product candidate, pemvidutide, in the treatment of obesity.

GAITHERSBURG, Md., Nov. 11, 2024 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Novavax’s Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates. The FDA has cleared the Company to begin enrolling the planned Phase 3 trial following the determination that Novavax satisfactorily addressed all clinical hold issues. Novavax will be working with the clinical trial investigators and other partners to resume trial activities as quickly as possible.

The Accelerate Investor Conference spurs the region’s innovation and startup ecosystem engagement to a new level and showcases the Virginia, Maryland, and metropolitan Washington, D.C., region as a destination for business development, venture investment, and job creation.

Each year the event grows in size and stature. This year Mason Enterprise, which plans the event, reports there were 480 registered attendees, 19 speakers, 48 company pitches, 72 investors judged and participated, and 14 student teams that pitched. 

The competition targeted entrepreneurs with early to mid-seed stage, high-growth businesses with the potential to have an immediate and positive impact on our local economy, as well as student concepts with longer-term business viability. After days of networking, engagement, and education, the winners were selected.

The Indo US Bridging RARE Summit 2024 is set to be an unmissable event for those dedicated to advancing rare disease research and fostering global collaborations. Taking place from November 16-18, 2024, this second annual summit is hosted by the Indo US Organization for Rare Diseases (IndoUSrare) in partnership with AIIMS (All India Institute of Medical Sciences, New Delhi) and other key partners. The main venue is the Indian National Science Academy (INSA) Campus, New Delhi, with an opening gala at the outdoor AIIMS Swimming Pool Venue on the evening of November 16th. Virtual participation will be available, offering opportunities for online networking, exhibits, and posters.

GAITHERSBURG, Md., Oct. 29, 2024 (GLOBE NEWSWIRE) — Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today that the first three patients in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma have been successfully dosed.

Ropidoxuridine (IPdR) is Shuttle Pharma’s lead candidate radiation sensitizer for use in combination with RT to treat brain tumors (glioblastoma), a deadly malignancy of the brain with no known cure. Shuttle has received Orphan Drug Designation from the FDA, providing potential marketing exclusivity upon first FDA approval for the disease.

Germantown, Maryland, and Venlo, the Netherlands, Nov. 04, 2024 (GLOBE NEWSWIRE) — QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx Meningitis/Encephalitis Panel for clinical use.

This marks the fourth QIAstat-Dx syndromic test to receive U.S. regulatory clearance in 2024.

Meningitis (inflammation of the membrane surrounding the brain and spinal cord) and encephalitis (inflammation within the brain) are medical emergencies that require immediate treatment. One in five cases of bacterial meningitis results in permanent complications, such as hearing loss, brain damage and seizures and without prompt treatment, about half of patients will die.

Baltimore, MD (October 24th, 2024) – 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 the closing of its $15 million Series A-2 financing. The round attracted several new institutional investors, strong participation from existing shareholders, and industry veterans in vascular and dialysis. New investors include Unorthodox Ventures, GenHenn Capital, JSTAR Capital, Oakwood Circle Ventures, Riptide Ventures and Partners Investment.

ROCKVILLE, Md., Oct. 23, 2024 /PRNewswire/ — Rise Therapeutics announced today that it has received funding from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institute of Health (NIH) to enable infrastructure improvement that will scale GMP production and accelerate quality assurance (QA) and quality control (QC), significantly enhancing its biologics drug manufacturing capabilities. This Commercial Readiness Pilot (CRP) Program SBIR award will also support Phase 2 clinical GMP manufacturing to advance Rise Therapeutics’ R-3750 program currently completing a Phase 1 proof-of-concept clinical trial in patients suffering from ulcerative colitis.

FREDERICK, Md., Oct. 23, 2024 /PRNewswire/ — Theradaptive, a privately held, clinical stage biologics company developing protein therapeutics for spine, orthopedics, soft tissue repair and targeted immuno-oncology, announced today that OsteoAdapt™ SP  has received the Gold Level Award for Best Technology in Spine 2024 by Orthopedics This Week.

COLUMBIA, Md., (October 24, 2024) –– TEDCO, Maryland’s economic engine for technology companies, announces the “Breaking Barriers and Building Futures: The Evolution of Women Entrepreneurs in Maryland” session at the 10^th Entrepreneur Expo, taking place on December 4, 2024, at the Renaissance Baltimore Harborplace Hotel.

The dynamic growth of women-led entrepreneurship in Maryland will take center stage in this insightful panel discussion featuring Jasmine Clemons, director of the Maryland Board of Public Works, Danette Nguyen, managing director of the Maryland Women’s Business Center and Samantha Scott, PhD, CEO and founder of JuneBrain. The conversation will explore the unique challenges women face in today’s business landscape, with a particular focus on access to capital, scaling strategies and the support systems necessary for sustained success.

The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced the teams selected by its Sprint for Women’s Health to receive awards. The agency committed over $110 million to fund solutions for health conditions that uniquely or disproportionately affect women. This effort will advance the White House Initiative on Women’s Health Research and help spur the type of innovation and private sector engagement long needed to improve women’s health.