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 (BUSINESS WIRE) -- Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational Prolia® and Xgeva® (denosumab) biosimilar. Denosumab has been approved in various countries and regions under different trade names for a range of different indications such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others. In 2019, it was estimated that 32 million Europeans ages 50 or above had osteoporosis, 25.5 million of which were women.1

The submissions were based on a randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study that aimed to compare the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference denosumab (Prolia) in postmenopa ... Read more »

Views: 11 | Added by: africa-live | Date: 05.27.2024 | Comments (0)


 (BUSINESS WIRE)--Bass Pro Shops Big Cedar Lodge announced today that on July 21 the Ozarks will rock as the ancient hills, valleys and lakes never have when the world’s greatest rock-and-roll band, The Rolling Stones, light up Thunder Ridge Nature Arena for the last performance on their final North American tour.

... Read more »

Views: 7 | Added by: africa-live | Date: 05.27.2024 | Comments (0)

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