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Japan Approvals Include World Firsts For Romosozumab, Spinal Injury Cell Therapy

 
• By Ian Haydock

The latest group of new product approvals in Japan includes the first marketing clearances worldwide for fracture-reducing osteoporosis antibody romosozumab and a stem cell-based therapy for spinal cord injury, as well as two new Daiichi drugs and Pfizer's lung cancer therapy dacomitinib. 

Red Approved Stamp with Wooden handle Rubber Stamper Isolated on White Background.
NEW JAPAN APPROVALS INCLUDE SEVERAL WORLD FIRSTS • Source: Shutterstock

Japan's Ministry of Health, Labour and Welfare has granted formal marketing authorizations to a group of new products, including the first such regulatory nods globally for several novel therapies.

The Tokyo-based Amgen Astellas BioPharma KK joint venture secured the first approval worldwide in early January for its anti-sclerostin antibody Evenity (romosozumab),

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