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

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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.

POMSnet Falcon Dives Into Pharma and Biotech GMP Facilities Across the Globe

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POMS Corporation releases POMSnet Falcon 2021.2 MES Dashboard and Analytics. POMSnet Falcon is perched to become the GMP facility standard for dashboards, reports, & analytics. Customers are flocking to install the data warehouse to aggregate batch record data across multiple geographies and provide a single point of access. POMS’s Software R&D team worked day and night for months to completely overhaul the outdated industry-standard PDF electronic batch record flat file. This tireless work has resulted in a data warehouse enabling pharma, biotech, and cell & gene therapy manufacturers to instantly access global batch record data and release products in real-time faster than any other product on the market.

This Charlottesville Company is Changing the Game in Wound Care

Headshot of Kevin Combs, CEO of Molecular Biologicals, with the MB logo as well as the logos for its Keragel and Keramatrix products
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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.

You’ve likely heard of keratin before in some aspect – this protein is an essential part of our hair, skin, and nails, and is found as an ingredient in many haircare products. While keratin is touted for its ability to strengthen hair and tame frizz, make no mistake – the keratin that Molecular Biologicals is manufacturing is much different than what you’d find in the beauty aisle at your local drugstore.

Women In Bio Diversifies More Than 100 Life Science Boardrooms

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Executive Women In Bio (EWIB), a Women In Bio (WIB) initiative, celebrates a milestone year in 2021 with the 100th Boardroom Ready Alumnae appointment to a corporate board in the life science industry. This year alone, more than 40 appointments took place, totaling 112 placements since the program’s inception. Boardroom Ready is an award-winning executive development platform designed to fuel women’s participation on corporate boards. 

VLP Therapeutics raises $21M Series A-1 for cancer treatment vaccine, infectious diseases vaccine R&D

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US-based biotech company VLP Therapeutics, Inc. (VLPT) announced on December 27 that it has signed an agreement for an investment of US$21 million in a Series A-1 round from six investors, consisting of two new investors: Nobelpharma Co., Ltd. and MUFG Bank, Ltd., and four existing investors: Sojitz Corporation, MIYAKO Capital Co., Ltd., Mr. Robert G. Hisaoka and SK Impact Fund, LLC.

Maryland Real Estate Roundup 2021

Collage with photos of Baltimore, Frederick, the Maryland flag, blue crabs, and text saying "Maryland Real Estate Roundup 2021"
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This year, Maryland continued to prove why it’s becoming one of the strongest biohealth clusters in the country. The state’s commitment to businesses in the life science, pharmaceutical, and biotech industries has continued as both the private and public sectors work to meet the demand for more space. Here are a few of the biggest real estate projects in Maryland in 2021. Some of these projects are still under construction, while others were unveiled this year. 

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

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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.

Women In Bio Elects Dr. Azurii Collier as 2022 President-Elect

Photo of Dr. Azurii Collier
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Women In Bio (WIB), a national organization of professionals committed to promoting the careers, leadership and entrepreneurship of all women in the life sciences, has elected Dr. Azurii Collier of the Greater Chicago area as the 2022 National President-Elect. Collier currently serves as the WIB-National Sponsorship Committee Chair and previously served as WIB-National Sponsorship Committee Co-Chair and as an active member of Women In Bio for six years.

American Gene Technologies’ HIV Clinical Trial Demonstrates Blood Markers of Efficacy

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American Gene Technologies (AGT), a clinical-stage biotechnology company working to cure HIV, announced that it has reached two important milestones for its HIV cure program. All three patients achieved engraftment of the genetically modified cell product, AGT103-T, and avoided rejection of the infused cells. In addition, patient samples were challenged to determine if their HIV-specific response remained active. All three products demonstrated an active response. These two studies confirm that the patients retained an appropriate concentration of the product and indicate AGT103-T should be able to create an effective immune response against HIV in the absence of antiretroviral treatment (ART).

Labcorp Strengthens Oncology Leadership Position With the Addition of Personal Genome Diagnostics, a Provider of Comprehensive Liquid Biopsy and Tissue-Based Genomic Products and Services

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Labcorp (NYSE: LH), a leading global life sciences company, today announced that it has entered into a definitive agreement to acquire Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics with a portfolio of comprehensive liquid biopsy and tissue-based products.