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Latest From Immunomedics, Inc.
Pink Sheet’s Drug Review Profile explores Amgen’s Wezlana, an interchangeable biosimilar to Janssen’s Stelara. FDA determined late in the review that switching studies generally would not be needed for interchangeable ustekinumab products, prompting Amgen to seek the designation.
Final guidance on assessing registries notes responsibility of sponsors to ensure reliability of data from other organizations and reduce loss of participants to follow-up, while final guidance on data standards for RWD acknowledges sponsors may have limited access to a study’s data sources.
All being well, the Italian firm will soon have the results from a late-stage study of evenamide in schizophrenia patients who show an inadequate response to atypical antipsychotics.
Formycon has announced the approval of its biosimilar ranibizumab by Health Canada, with commercial launch by Teva expected to begin in Q1 next year.
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