Europe Too: Approval Of A Higher Dose Glatiramer Generic
Like in the US, Teva's more convenient three-times-a-week dosage form of Copaxone is now facing competition in Europe from a generic, in this case one developed by the Netherlands' Synthon and Iceland's Alvogen.
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Mylan has celebrated a reversal from the European Patent Office that has seen a key patent protecting Teva’s higher-strength 40mg/ml thrice-weekly version of Copaxone deemed invalid and revoked across Europe. Meanwhile, Teva has commented on the possibility of an appeal.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Alexion/AstraZeneca has announced positive top-line results from the Phase III study of ALXN1840 in patients with the rare genetic disorder, Wilson disease, including in patients already on standard-of-care therapies. The compound is ahead of two candidate gene therapies from other companies at early-stage clinical development.