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LA JOLLA, CA — January 9, 2017 — Synthetic Genomics Inc. announced today that its subsidiary, SGI-DNA, has launched Vmax™ Express, a highly advanced bacterial host organism designed for significant improvement in recombinant protein expression. Compatible with standard plasmids, antibiotics and growth media used in other bacterial protein expression systems, Vmax™ Express generates larger amounts of soluble recombinant proteins faster and more efficiently than E. coli-based systems. “E. coli host organisms have been tweaked for incremental refinement for decades, but the development and commercialization of Vmax™ Express marks a dramatic step forward,” said Daniel Gibson, Ph.D., vice president of DNA technologies at Synthetic Genomics. “Our team of scientists began with a clean slate — unconstrained by the inherent limitations of E. coli — and designed a novel, advanced, fast-growing host organism that will translate into next-generation protein production in the research as well as biopharma and industrial biotechnology production settings.” E. coli is the most widely-used organism in molecular genetic research and accounts for the production of 30 percent of FDA-approved biologic drugs. Vmax™ Express can replace slow-growing E. coli systems, which are prone to low yields and the expression of insoluble protein. Vmax™ Express offers several advantages over E. coli including: higher levels of protein expression (Vmax™ Express delivers at least double the amount of protein per milliliter); increased speed (approximate two-fold improvement in replication time); increased compatibility with a range of proteins that may be difficult to express in E. coli; and rapid results: protein purification in three days (one full day faster than E. coli, from cells to large-scale culture). Vmax™ Express is derived from the marine microorganism Vibrio natriegens, a gram-negative, non-pathogenic bacterium that exhibits the fastest growth rate of any known organism. Vmax™ [...]

HERTFORDSHIRE, England and PITTSBURGH, Feb. 20, 2018 /PRNewswire/ -- Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) today announced receipt of tentative approval from the U.S. Food and Drug Administration (FDA) under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg. The antiretroviral (ARV) will be immediately available in developing countries as a first-line regimen for people being treated for HIV/AIDS. Mylan is the world's largest producer of HIV/AIDS drugs, and more than 40% of people being treated worldwide for HIV/AIDS depend on a Mylan antiretroviral product. "The FDA's tentative approval of Mylan's Dolutegravir, Emtricitabine, and Tenofovir Alafenamide Tablets sets a new standard for affordable access for patients in countries hardest hit by HIV, as it's the first time a product combines dolutegravir and tenofovir alafenamide," said Mylan CEO Heather Bresch. "With limited funding, the world needs cost competitive and clinically effective products like this one, and Mylan is proud to work with partners to make it available and help reach the more than 15 million people living with HIV worldwide who still need access to treatment." Mylan's ARV is a once-daily, fixed-dose combination of Dolutegravir, Emtricitabine and Tenofovir Alafenamide, the individual components that make up ViiV Healthcare's Tivicay® and Gilead's Descovy®. Mylan manufactures these products under licenses from the Medicines Patent Pool and Gilead Sciences, respectively. This is the first tentative approval of Tenofovir Alafenamide and comes just two years after the FDA approval of Descovy®. The combination of these agents is currently included as a "Recommended Initial Regimen for Most People with HIV" in the HIV guidelines of the U.S. Department of Health and Human Services. "In the past decade, Mylan has committed itself again and again to bringing new [...]