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AbbvieRegen

AbbVie and REGENXBIO Announce Updates on the ABBV-RGX-314 Clinical Program

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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 AbbvieRegenprogram.

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.

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Novavax Logo

Novavax is Powering the Future of Vaccines Through R&D and Value-creating Business Strategy

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Novavax LogoJanuary 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

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VEDP2

VEDP: Booming Virginia clusters provide a supply chain blueprint for increasing drug accessibility, affordability

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VEDP2Like 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.”

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Emergent

Emergent BioSolutions Receives Contract Option Valued at Approximately $16.7 Million to Continue Development Collaboration with BARDA on Ebanga™ (ansuvimab-zykl) Treatment for Ebola

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EmergentGAITHERSBURG, Md., Jan. 13, 2025 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, executed a contract modification for the second option period, valued at approximately $16.7 million, for drug product process and analytical testing validation and long-term stability for Ebanga™ (ansuvimab-zykl). Ebanga™ is indicated for the treatment of infection caused by Zaire Ebola virus.

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Baltimorebiopark

The Baltimore Banner: University of Maryland merges engineering and medicine to turn ideas into companies

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BaltimorebioparkIt’s Baltimore’s latest move toward becoming a tech hub

Meredith Cohn – It looks like a rolling suitcase, a mask and some tubes, but for some people who can’t breathe properly, the device will mean freedom.

Those with damaged lungs who are waiting for a transplant, too sick for surgery or just temporarily injured normally have to stay hooked up to bulky machinery in a hospital to stay alive. But a new invention, developed by engineers and doctors from the University of Maryland, means they could soon return home and go about more of their lives.

“Grandpa can come [along] now,” said Dr. Bartley P. Griffith, a professor of transplant surgery in the university’s School of Medicine, about the artificial lung support device he helped create and commercialize before it was bought by Johnson & Johnson.

 

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ARPA H RAPID

ARPA-H RAPID Program: Rare Disease AI/ML for Precision Integrated Diagnostics

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ARPA H RAPID*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.  

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Veralox

Veralox Therapeutics Expands Its Pipeline with the Exclusive Option to Acquire Nudge Therapeutics

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VeraloxFREDERICK, Md.Jan. 9, 2025 /PRNewswire/ — Veralox Therapeutics, a clinical-stage biotechnology company developing a new class of therapies targeting the 12-lipoxygenase (12-LOX) pathway, announced today that it has entered into an exclusive agreement with Nudge Therapeutics to acquire the company and their preclinical cyclic AMP-GMP (cGAS) inhibitor compounds.  The agreement allows Veralox to continue development of Nudge’s compounds and trigger acquisition of the company upon achievement of downstream milestones. Financial terms were not disclosed.

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Qiagen

QIAGEN secures U.S. clearance for first QIAstat-Dx mini gastrointestinal panel to support year-round outpatient care

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QiagenGERMANTOWN, Md., & VENLO, The Netherlands–()–QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. regulatory clearance of the first in a series of QIAstat-Dx Gastrointestinal Panel tests for clinical use.

This clearance by the U.S. Food and Drug Administration (FDA) marks the second mini syndromic panel in the U.S. and made available for use with QIAstat-Dx systems, supporting QIAGEN’s strategy to improve patient treatment options in this important market.

The 2025 clearance involves the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (bacterial and viral) covering five causes of gastrointestinal illness that are recommended by the Infectious Diseases Society of America (IDSA): the bacteria CampylobacterSalmonella, Shiga-like toxin E.Coli (STEC) and Shigella, along with Norovirus, one of the most common causes of gastrointestinal infection and an important target during the winter season.

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Nextcure logo

NextCure Announces First Patient Dosed in the Phase 1 Study of LNCB74 (B7-H4 ADC) as Therapeutic for Treating Multiple Cancers

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Nextcure logoBELTSVILLE, Md., Jan. 10, 2025 (GLOBE NEWSWIRE) — NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today announced the first patient has been dosed in its Phase 1 study of LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers.

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Tompkins

Montgomery County Economic Development Corporation President and CEO Bill Tompkins Plans to Step Down at the End of His Current Term

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TompkinsMontgomery County, MD — The Montgomery County Economic Development Corporation (MCEDC) announced that Bill Tompkins will step down as President & CEO when his term ends in August 2025. Tompkins has served in this role since August 15, 2022.

“This marks a significant moment for MCEDC,” stated Elana Fine, Chair of the Board of Directors. “We extend our gratitude to Bill for his outstanding leadership over the past six years, as both the Chief Operating Officer and as President & CEO. His dedication has laid a strong foundation for future growth while fostering inclusion, driving collaboration, and ensuring stability during challenging times.”

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