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romosozumab

This page shows the latest romosozumab news and features for those working in and with pharma, biotech and healthcare.

FDA rejects Amgen's osteoporosis hope romosozumab

FDA rejects Amgen's osteoporosis hope romosozumab

The FDA has turned down Amgen's marketing application for osteoporosis candidate romosozumab, asking for new data that could delay any approval significantly. ... The FDA's complete response letter (CRL) does not come out of the blue as Amgen and its

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  • CHMP recommends Merck & Co's Lantus biosimilar CHMP recommends Merck & Co's Lantus biosimilar

    competition. Furthermore, Amgen and UCB's rival osteoporosis drug romosozumab has demonstrated superior results to Forteo in phase III trials, and analysts have suggested the emerging anti-sclerostin antibody class will

  • Amgen's Kyprolis scarred by head-to-head duel with Velcade Amgen's Kyprolis scarred by head-to-head duel with Velcade

    Romosozumab filed  . There was some better news for Amgen and partner UCB this week when the FDA started its review of romosozumab, their drug candidate for the treatment of osteoporosis in ... Romosozumab did well in phase III trials - cutting the risk

  • Merck decision to drop odanacatib lifts UCB/Amgen Merck decision to drop odanacatib lifts UCB/Amgen

    Their anti-sclerostin antibody romosozumab is well ahead of other drugs in the emerging class and has been shown to be superior to Eli Lilly's big-selling osteoporosis therapy Forteo ... Deutsche Bank analysts have said they see romosozumab and

  • Amgen and UCB's romosozumab hits goals in male osteoporosis Amgen and UCB's romosozumab hits goals in male osteoporosis

    Patients in the trial were given a subcutaneous injection of romosozumab or placebo every month for a year. ... Amgen and UCB previously reported data showing romosozumab was superior to Forteo, which also requires daily dosing by injection.

  • Amgen says romosozumab on track for 2016 filing Amgen says romosozumab on track for 2016 filing

    Importantly, at 12 months the reduction was around 73 per cent, indicating that romosozumab can get to work quickly in reducing risk. ... Romosozumab was previously in development to accelerate the healing of fractures, but failed to show efficacy in

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Latest Intelligence

  • Investing in the future of R&D Investing in the future of R&D

    One of UCB's brightest prospects is its osteoporosis candidate romosozumab. In January phase II trial results were published that showed significant increases in low bone mineral density at both spine

  • VIDEO interview: Neil Weir, UCB VIDEO interview: Neil Weir, UCB

    Providing an example, he explains UCB's use of genetics in its development of romosozumab, currently in phase III investigation in partnership with Amgen for use in the treatment of ... UCB's work on romosozumab with Amgen is also an example of the

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Approximately 0 fully matching, plus 2 partially matching documents found.

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