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The acquisition will give Sanofi full global rights to KY1005, Kymab’s fully human monoclonal antibody that binds to OX40-Ligand, giving it the potential to treat a variety of immune-mediated diseases and inflammatory disorders. 

Sanofi to Acquire Kymab for $1.4 Billion

Under the terms of the agreement, operations will be initiated at Lonza’s Houston, TX Center of Excellence where Lonza will handle process development activities for late-clinical and commercial-scale GMP manufacturing of the cell therapy.

Lonza to Partner with Capricor Therapeutics for the Development of Duchenne Muscular Dystrophy Cell Therapy 

WuXi STA served as the marketing authorization holder (MAH) and offered end-to-end support, including drug substance, amorphous solid dispersion, tablet, and packaging for the product.



WuXi STA Supports Approval from NMPA for Orelabrutinib from InnoCare

The company is recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) because of nitrosamine impurities.

Nostrum Laboratories Expands Recall of Metformin HCl Extended Release Tablets

A strategic separation is designed to enhance the value and growth of Paraxel’s contract research services and Calyx’s imaging businesses.

Parexel Informatics and Imaging Business Relaunches as Calyx

Baxter will provide commercial-scale manufacturing services at its Halle/Westfalen, Germany facility to prepare Novavax’s COVID-19 vaccine candidate for distribution in the United Kingdom and European markets.

Baxter and Novavax Enter into COVID-19 Vaccine Sterile Manufacturing Agreement

The company plans to expand its global production capacity across six existing manufacturing facilities in Europe and the United States, as well as a new manufacturing facility in the US.

Pall to Invest $114 Million to Expand its Global Production Capacity

The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.

FDA Gives Guidance on Gene Therapy for Neurodegenerative Diseases 

The new facility, which will be operated by Fujifilm Diosynth Biotechnologies, will provide large-scale cell-culture manufacturing of bulk drug substance with 8 x 20,000-L bioreactors.

Fujifilm to Invest Over $2 Billion into US Biopharmaceutical Manufacturing Facility  

The company plans to deliver initial doses by mid-2021, and Australia will have the option to purchase up to 10 million additional doses through the agreement. 

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