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UK vaccine clinical trial outsourcing expansion continues
An outsourcing company has announced that Phase II, III and IV clinical trials of vaccines will continue at a growing number of sites, assessing the safety of each in light of COVID-19.
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EC approves treatment for severe osteoporosis postmenopausal women
Marketing authorisation has been granted by the EC for Evenity® (romosozumab) to treat osteoporosis in postmenopausal women.
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Seven medicines recommended for approval by EMA
The EMA CHMP has given a positive opinion for marketing authorisation approval to seven medicines following its October meeting.
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Terrosa® osteoporosis biosimilar treatment launched in Europe
A new biosimilar drug to treat osteoporosis is now available across Europe after the patent for its reference product expired.
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EMA releases medicinal approval recommendations
The EMA has given its approval recommendation to three drugs and announced negative opinions for approval on others.
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FDA approves Prolia for glucocorticoid-induced osteoporosis
The FDA has approved the use of Prolia for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture...
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EMA accepts MAA for romosozumab in the treatment of osteoporosis
The EMA has accepted the Marketing Authorization Application for romosozumab in the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture...
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Romosozumab provides protection against fractures in osteoporosis
A new treatment for osteoporosis provides major improvements in bone density and fractures than the current standard treatment...
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Pfizer and Lilly receive FDA fast track designation for tanezumab
The FDA has granted fast track designation for Pfizer and Eli Lilly’s tanezumab for the treatment of chronic pain in patients with osteoarthritis...
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UCB and Amgen submit FDA application for Osteoporosis drug
22 July 2016 | By Niamh Louise Marriott, Digital Content Producer
UCB and Amgen today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for romosozumab, an investigational, monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture...
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APAC osteoporosis market to hit $7.7 billion by 2022, says GBI Research
19 July 2016 | By Victoria White, Digital Content Producer
The Asia-Pacific (APAC) osteoporosis market is set to grow from $4.5 billion in 2015 to $7.7 billion in 2022, according to GBI Research...
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Positive top-line results from Phase III study of romosozumab in osteoporosis
21 March 2016 | By Victoria White
The study demonstrated a statistically significant increase in bone mineral density at the lumbar spine in men with osteoporosis treated with romosozumab...
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Positive top-line results for romosozumab FRAME study
23 February 2016 | By Victoria White
The Phase III FRAME study evaluated UCB and Amgen's romosozumab in postmenopausal women with osteoporosis...