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.