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  • Regulatory NewsRegulatory News

    FDA Advisory Committee Recommends Amgen-UCB Osteoporosis Drug

    With a final vote of 18-1, the bone, reproductive and urologic drugs advisory committee (BRUDAC) wrapped up a hearing on Wednesday with a recommendation that the US Food and Drug Administration (FDA) approve Amgen and UCB’s Evenity (romosozumab) osteoporosis treatment. The BRUDAC hearing on Wednesday marked Amgen and UCB’s second review for Evenity. The new recommendation comes after FDA issued a Complete Response Letter in July 2017 for the Biologics License Applicat...
  • Regulatory NewsRegulatory News

    FDA Denies Amneal Petition Seeking to Block Generic Versions of Osteoporosis Treatment

    Capping a string of recent citizen petition denials, the US Food and Drug Administration (FDA) has rejected Amneal Pharmaceuticals' citizen petition asking the agency to refrain from approving any abbreviated new drug applications (ANDAs) for the blockbuster osteoporosis treatment Forteo (teriparatide). The decision by FDA was not unexpected and followed recent denials of citizen petitions filed by Novo Nordisk and Allergan . Bernstein biotech analyst Ronny ...
  • Regulatory NewsRegulatory News

    FDA Issues New Guidance on Osteoporosis Drug Development

    The US Food and Drug Administration (FDA) on Monday issued new draft guidance calling for drugmakers to conduct long-term nonclinical bone quality studies for osteoporosis treatments. According to FDA, such studies are necessary for osteoporosis drugs to determine whether the drugs result in poorer bone quality when taken for long periods of time. Additionally, FDA says these studies should be nonclinical, as "there are no validated and reliable methods for the noninvasi...
  • Revisions to Osteoporosis Guideline Called for by EMA

    The European Medicines Agency (EMA) has released a new concept paper calling for revisions to the way osteoporosis products are evaluated in the EU, saying existing guidelines are largely inadequate to assess a secondary form of the disease. The problem, explained EMA, is that current osteoporosis guidelines only cover primary osteoporosis, and do not address the evaluation of products used to treat secondary osteoporosis, often brought on by glucocorticoid therapy. Gl...
  • EMA Issues Warning on Osteoporosis Medicines

    The European Medicines Agency (EMA) announced Friday, 20 June it would recommend against the long-term use of calcitonin-containing medicines, most commonly used to treat or prevent osteoporosis While the drugs will still be permitted for short-term use for some indications, the agency said there was evidence of an increased risk of cancer when the medications are taken over the long-term. As a result, the medicines should no longer be used to treat osteoporosis, EMA sai...