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REGENXBIO Announces FDA Clearance of IND for Clinical Trial of RGX-202, a Novel Gene Therapy Candidate for Duchenne Muscular Dystrophy

By News Archive

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ROCKVILLE, Md., Jan. 6, 2022 /PRNewswire/ —

  • Potential one-time gene therapy for the treatment of Duchenne includes a novel, optimized microdystrophin transgene and REGENXBIO’s proprietary NAV® AAV8 vector 
  • Innovative trial design, including comprehensive immunosuppressive regimen, to evaluate safety and optimal dose 
  • cGMP process material made at commercial-scale to be used throughout clinical development of RGX-202
  • REGENXBIO expects to initiate trial in the first half of 2022

REGENXBIO Inc. (Nasdaq: RGNX) today announced the clearance of its Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA) to evaluate RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne) in a first-in-human clinical trial. RGX-202 is designed to deliver a transgene for a novel microdystrophin that includes the functional elements of the C-Terminal (CT) domain found in naturally occurring dystrophin. RGX-202 uses REGENXBIO’s proprietary NAV® AAV8 vector. REGENXBIO plans to initiate the trial in the first half of 2022.

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Zalgen

Zalgen Labs’ move to Frederick is another sign of the BioHealth Capital Region’s strengths

By News Archive

Zalgen

Maryland biotech company Zalgen Labs has moved to Frederick, illustrating the magnetism of the biotech hub for leaders like its own Dr. Luis Branco who want to capitalize on the new sense of collaboration the pandemic has brought about in life sciences companies in the region.

The move to Frederick puts Zalgen closer to the epicenter of what’s known as BioHealth Capital Region (BHCR) that encompasses Maryland, Virginia and DC. Frederick alone is home to over 80 biotech companies, according to the county’s Office of Economic Development.

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Molecular Biologicals

BioBuzz: Charlottesville’s Molecular Biologicals is Changing the Game in Wound Care BioBuzz: Charlottesville’s Molecular Biologicals is Changing the Game in Wound C

By News Archive

Molecular Biologicals

Imagine you’re working outside and accidentally cut your foot on a protruding stick you didn’t see. No big deal. You go inside and wash the wound, perhaps applying an antibiotic cream, and dress it in a bandage. Days and weeks, even months go by, however, and the wound just doesn’t want to seem to fully heal. Even the simplest of tasks such as walking becomes extremely painful, and just one wrong move reopens the wound.

For millions around the world, this is their daily reality. From diabetic ulcers to bedsores, from burns to cancer complications to infections, chronic wounds are complex and vastly underappreciated as a therapeutic space.

Molecular Biologicals, located in the blossoming biotech hub of Charlottesville, VA, is working to change the game in chronic wound care through its unique and proprietary keratin manufacturing platform.

Click here to read more via BioBuzz.

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Dr. James Crowe, Director of the Vanderbilt Vaccine Center Visits Bloomberg Markets: America, and CNBC’s Squawk Box

By News Archive

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On this snowy start to 2022, I wanted to share with you two interviews with AHEAD100 Chief Scientist Dr. James Crowe that occurred over the last week on CNBC and Bloomberg TV. Each piece is a powerful continuation of our work to build awareness and support for the work of the Global Pandemic Prevention and Biodefense Center and lead initiative, AHEAD100 — and together, they garnered more than 100 million impressions, representing more than $1 million in advertising value equivalent.

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BHI Recruiting a Senior Analyst, Immediate Opening.

By News Archive

BHI LogoBioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia). We are seeking a Life Sciences Business Strategist to join our team remotely.

The right candidate will be an energetic and continuous learner who is passionate about accelerating the adoption of new technologies to improve lives. The position is geared toward an early-career scientist (generally in their first 5-7 years after receiving their PhD) who wants to engage with the biohealth industry in new ways.

Download the Full Job Description.

 
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Best Tech Innovation Companies Exhibiting at the CES 2022

By News Archive

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Global health tech companies are queueing up for one of the world’s largest in-person events of the New Year- CES 2022. The global health tech event would showcase innovative ideas from over 2200+ exhibitors between 5 and 8 January in Las Vegas. CES 2022 will go forward as an important innovation for world health and safety, mobility and solving problems will be exhibited. Furthermore, thousands of smaller and medium-sized companies rely on CES for their business.

Image: https://aithority.com

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Novavax Announces Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies

By News Archive

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Two-dose primary regimen of NVX-CoV2373 demonstrated cross-reactive immune responses against

Omicron (B.1.1.529) and other variants

Third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials, with a 9.3-fold IgG rise and a 19.9-fold ACE2 inhibition increase after booster dose

Immune responses in adolescents were 2- to 4-fold higher than adults against broad array of variants of interest and variants of concern Development of Omicron-specific vaccine on track for initiation of GMP manufacturing in early January

Company to host investor conference call today from 4:30 – 5:00 pm ET

GAITHERSBURG, Md., Dec. 22, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced initial data evaluating the immune response of its COVID-19 vaccine, NVX-CoV2373, against the Omicron variant as well as additional data from its ongoing Phase 2 boost study. New results demonstrate broad cross-reactivity against Omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months.

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USM Economic Impact 2021 pdf

THE ECONOMIC IMPACT OF THE UNIVERSITY SYSTEM OF MARYLAND

By News Archive

USM Economic Impact 2021 pdf

The University System of Maryland (USM) retained the Jacob France Institute of the University of Baltimore to prepare this update of the prior 2012 The Economic Impact of the University System of Maryland: A Fiscal Perspective FY2011 report. This analysis uses the Human Capital Approach to assess the system’s economic impact and State of Maryland’s return on its investment by assessing the incremental earnings impacts associated with four cohorts of USM graduates and the current impacts of out-of-state spending attracted to Maryland by the USM. The key findings of this analysis are as follows:

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Governor Hogan Announces New MDTA, MTA and Dept. of Commerce leaders | WBFF

By News Archive

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On Thursday, Governor Larry Hogan announced three key appointments in Maryland.

Former Maryland Secretary of Commerce Mike Gill has been named secretary of the Maryland Department of Commerce, succeeding Secretary Kelly Schulz.

Gill is chairman of Columbia-based Evergreen Advisors, which was his role prior to serving as Maryland’s secretary of commerce from 2015 to 2019. He has four decades of experience in business, which includes founding Hoyt Capital, an investment and advisory firm serving startups and growth companies. He served as a member of the University System of Maryland Board of Regents from 2004 to 2009.

Image: Photo of Maryland flag at Annapolis State House (WBFF)

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The Most Active Biotech Venture Investors in 2021 – Crunchbase News

By News Archive

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Investment into biotech and health care boomed during the pandemic as thousands of venture capital firms turned their attention to breakthrough artificial intelligence, cancer-detection technology, mental health treatments, digital doctor visits, diagnostics and more. 

But two of those investment firms have emerged as major leaders, not only in the number of biotech funding rounds led, but also in overall dollars invested into the industry. Boston-based RA Capital Management and New York-based OrbiMed ranked first and second, respectively, on the two lists compiled using Crunchbase data. 

Image: https://news.crunchbase.com

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