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AGS Therapeutics Unveils Ambitious R&D Pipeline, Showcasing the Potential of its Universal Delivery System for Novel Therapeutics

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The company’s MEV universal delivery system has the potential to overcome biological barriers in the body and solve current drug delivery challenges.

Paris, April 3, 2023 – AGS Therapeutics, an early-stage biotech company pioneering micro-algae extracellular vesicles (MEV) as a new delivery system for innovative therapeutic treatments, today announced its initial internal research and development (R&D) pipeline. It is designed to showcase the potential of its MEVs as a new groundbreaking delivery system for bringing a wide range of payloads, including mRNA, siRNA, plasmid-DNA, antisense oligonucleotides (ASO), peptides, and proteins, to a variety of tissues and organs for treatment of a wide range of diseases. MEVs can overcome many of the challenges met by current delivery systems based on mammalian extracellular vesicles and on synthetic lipid nanoparticles. [Read more…]

Boston BioProducts Receives ISO 13485:2016 Quality Certification

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Boston BioProducts establishes the ability to meet medical device quality requirements under ISO 13485:2016

April 6, 2023, MILFORD, Mass., – Boston BioProducts, a longstanding manufacturer of fundamental reagents for the life sciences, today announced that its quality management system (QMS) has achieved ISO 13485:2016 certification from TÜV SÜD America for the medical device manufacturing and supply of buffers, solutions, media, and reagents serving research, diagnostics, and therapeutics applications. Achieving this certification signifies Boston BioProducts’ commitment to high-quality standards across the entire reagent manufacturing process. [Read more…]

U.S. FDA Grants RMAT Designation to Intellia Therapeutics for NTLA-2002 in Treatment of Hereditary Angioedema

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March 21, 2023, CAMBRIDGE, Mass. – Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapies leveraging CRISPR-based technologies, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to NTLA-2002 for the treatment of hereditary angioedema (HAE). NTLA-2002 is an in vivo CRISPR-based investigational therapy designed to inactivate the target gene, kallikrein B1 (KLKB1), to potentially prevent life-threatening swelling attacks in people with HAE. [Read more…]

GOOD Meat, the World’s First-to-Market Cultivated Meat Company, Receives U.S. FDA Clearance

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Acclaimed chef José Andrés will be first in the country to serve GOOD Meat’s chicken

ALAMEDA, Calif.–GOOD Meat, the cultivated meat division of food technology company Eat Just, Inc., announced today that it has received a “no questions” letter from the U.S. Food and Drug Administration as part of one of the agency’s first pre-market consultations for a new kind of meat, poultry and seafood made from cells instead of raised and slaughtered animals. The letter means that following a careful and rigorous evaluation, the FDA has accepted the company’s conclusion that its first poultry product, cultivated chicken, is safe to eat. [Read more…]

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