Astellas Pharma has agreed to acquire Mitobridge, a company developing small-molecule therapeutics that improve mitochondrial functions, in a deal worth up to $450 million. The companies had a previous R&D collaboration focused on discovering and developing drugs to treat genetic, metabolic, or neurodegenerative disorders as well as conditions of aging. Read More

The FDA has approved Ogivri, a biosimilar to Roche’s Herceptin, from Mylan and Biocon. Herceptin had 2016 global sales of CHF 6.78 billion ($7.03 billion). Read More

Daiichi Sankyo’s PharmaForce, a sterile drug product development and manufacturing company, will invest $145 million to expand two of its existing facilities in the area of Columbus, Ohio. Read More

Roche has completed its sale of its solid-dosage manufacturing facility in Leganés, Spain to Recipharm, a Jordbro, Sweden-headquartered CDMO. Read More

German regulatory authorities have approved Dr. Reddy’s Laboratories’ corrective and preventive action plan for its formulations manufacturing facility in Duvvada, India and have permitted production to start again for the European Union market. Read More

The Medicines Company has agreed to sell its infectious disease business unit to Melinta Therapeutics for $270 million in upfront consideration and guaranteed payments. The move follows a previously announced restructuring by The Medicines Company. Read More

FDA Commissioner Scott Gottlieb testified before the US House of Representatives’ Energy and Commerce Committee on November 30, 2017 about the agency’s implementation of the  21st Century Cures Act , which is designed to help accelerate medical-product development. Read More

WuXi Biologics, part of WuXi AppTec, a contract service provider, has opened a cGMP biologics manufacturing facility in Wuxi, China for full operations. Read More

The FDA has issued final guidance to clarify what the FDA recommends manufacturers include on submissions for 3D-printed medical devices. The technical guidance is categorized by the FDA as a “leap-frog” guidance because it helps bridge current and future technology. Read More

The FDA has released three new digital health policy documents to outline the FDA’s approach in the development and oversight of digital health tools.   Read More