Teva Pushes CGRP Timeline Back To End Of 2018
Management said the migraine drug fremanezumab could launch in the US by the end of the year following discussions with the US FDA. The June timeline has been delayed by a Celltrion manufacturing issue.
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The FDA is not approving two biosimilars from Teva and Celltrion over concerns about the latter's facility, leading to more speculation that approval of the Israeli firm's potential migraine blockbuster, manufactured at the same plant, may be delayed.
Sandoz's Less Frequently Dosed Copaxone Generic Glatopa Hits Teva Two Months Early
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Bad News Teva Really Doesn't Need: A Potential Delay For Fremanezumab
One of Teva's few bright spots is its leading position in the big new commercial opportunity for migraine, but its CGRP drug fremanezumab could now be delayed by an issue at third-party manufacturer Celltrion.