Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer by volume, today announced a regulatory submission to the South African Health Products Regulatory Agency (SAHPRA) for emergency use authorization (EUA) of Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant. If authorized, the vaccine (known as NVX-CoV2373) will be manufactured by and commercialized by SII in South Africa under the brand name Covovax™.
Automated Control Concepts (ACC) is proud to announce that Kevin Hannigan has been appointed CEO. Kevin’s previous leadership as President of ACC has been instrumental in helping ACC achieve our recent level of remarkable success, culminating in the investment from our new partners, Sverica Capital Management. His vision for our growth is exciting and frankly inspirational.
Infectious Disease Focused Zalgen Labs Opens New HQ in Frederick, Eyes Clinical Trial for Lassa Fever Therapeutic
Zalgen Labs, which until late December been housed at the Germantown Innovation Center for the past eight years, is focused on developing diagnostics and therapeutics for infectious emerging viral threats that have become endemic in the far corners of the world, including diseases such as Lassa fever, Ebola and other hemorrhagic diseases.
5 Questions with Geeta Peverada, Ph.D., P.M.P., Program Manager, Quality Control at Catalent Pharma Solutions
Geeta Peverada is a highly motivated, data-driven, and goal-oriented program management professional with over 12 years of experience in cancer research and gene therapy. She is bridging the gap between science and business through her expertise in client management and scientific knowledge. Her analytical, leadership, and management expertise has led to strengthened client partnerships at her current organization, Catalent Pharma Solutions.
Avalo Reports Positive Phase 1b Results for AVTX-002 in Moderate to Severe Crohn’s Disease Patients and Presents Additional Program Updates at 2022 Investor Event
Avalo Therapeutics, Inc. (Nasdaq: AVTX), a leading clinical-stage precision medicine company that discovers, develops, and commercializes targeted therapeutics for patients with significant unmet clinical need in immunology and rare genetic diseases, today provides a comprehensive update on the Company’s growth opportunities and mid-stage development portfolio.
REGENXBIO Announces FDA Clearance of IND for Clinical Trial of RGX-202, a Novel Gene Therapy Candidate for Duchenne Muscular Dystrophy
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.
Texcell – North America, Inc., part of the Texcell Group of global biosafety contract research organizations, held a breaking ground ceremony for a new facility on December 6, 2021, in Frederick, MD. The expansion is a next step in Texcell’s growth trajectory as they increase capabilities for all their service lines, including customized R&D cell culture, GLP viral clearance studies, and select GMP assay capabilities for viral safety testing. The multimillion-dollar facility will add 27,000 square feet of laboratory and office space, more than doubling Texcell’s current capacity for biosafety testing and viral clearance studies. The completion date is projected for the first quarter of 2023.
American Gene Technologies (AGT) announces the appointment of Dr. Drew Palin as business and strategy advisor to Jeff Galvin, CEO.
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.
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.