Not exact matches
Pagan said that a larger, more comprehensive study must be done before determining the
drug's true impact, but if the
drug's effectiveness is confirmed in such tests,
nilotinib could become the first treatment to impede the killing of brain cells that's consistent with Parkinson's, according to NPR.
In the proof of concept study, 12 patients received
nilotinib, an FDA - approved
drug for leukemia.
In a significant, yet unusual judgment the Court of Justice of the European Union (CJEU) upheld the General Court's decision (T - 140 / 12; Teva Pharma v. EMA) that had affirmed the European Medicines Agency's (EMA) rejection of Teva's generic
drug application for Glivec ® (active substance - imatinib), not due to the reference product's own orphan
drug exclusivity but in view of orphan
drug exclusivity of a similar medicinal product — Tasigna ® (active substance -
nilotinib).
However, the General Court upheld the EMA's decision refusing Teva's generic application for imatinib in view of
nilotinib's orphan
drug exclusivity pertaining to CML.
Thus, in view of the similarity of Teva's generic product to that of
nilotinib and its orphan exclusivity the General Court validated the EMA's rejection of Teva's generic
drug application.