Abzena is a Global Partner Research Organization (PRO) specializing in the integrated development and manufacture of complex biologics and bioconjugates has announced that the location of its new GMP manufacturing facility will be Sanford, North Carolina.   The significant expansion of Abzena’s capacity is driven by an increase in customer demand for commercial scale 2000L single use bioreactors across a wide range of therapeutic areas.  Sanford will be Abzena’s 6th

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MannKind Corporation and United Therapeutics reached a milestone in the development of Tyvaso DPI™ as United Therapeutics submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA). “The NDA submitted today by United Therapeutics builds upon a drug master file previously submitted by MannKind,” said Michael Castagna, CEO of MannKind Corporation. “We are excited to see the second compound formulated with our technology complete a rig

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Terumo Blood and Cell Technologies and CSL Plasma announce a collaboration to deliver a new plasma collection platform at CSL Plasma U.S. collection centers. A clinical trial of the investigational plasmapheresis device began earlier this month, and introduction of the new platform is subject to U.S. Food and Drug Administration device clearance, at which time the parties will provide further comment. Plasma is a key ingredient for therapies crucial to treating patients around the w

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Lyndra Therapeutics, a clinical-stage biotechnology company working to make daily pills a thing of the past, announced results from its Phase 2 study of LYN-005, the Company’s oral, ultra-long-acting, extended-release (ER) risperidone capsule, in development for the weekly treatment of schizophrenia. These data, from the Company’s first repeat dose Phase 2 study in patients, demonstrate that LYN-005 provided sustained therapeutic levels of risperidone over the one-week dosing inte

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The U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatmen

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ProBioGen announced today that Nouscom has activated a commercial product license to ProBioGen's innovative, cell-based vaccine platform AGE1.CR.pIX. ProBioGen's AGE1.CR.pIX cell line was designed for large scale industrial production of various vaccines and viral vectors. The cell line was developed at ProBioGen from primary duck cells, is adapted to suspension-growth and comes with a specifically designed, chemically-defined medium and full documentation. Elisa S

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Sutro Biopharma, Inc., a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, announced that Merck, known as MSD outside the United States and Canada, will make to Sutro a $15 million milestone payment for the initiation of an IND enabling toxicology study for the first program in its collaboration to develop novel cytokine derivative ther

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RubrYc Therapeutics, Inc., a company that conducts preclinical biotherapeutic research into epitope-selective therapies, announced a collaborative research collaboration and licensing agreement with Zai Labs, Inc. in the use of the MEMs (Meso-scale Engineered Molecules) platform, used to identify monoclonal antibodies with enhanced biological function for an undisclosed oncological target. Under the terms of the agreement, RubrYc and Zai Labs will work together to single out product

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