Sentences with phrase «of nilotinib»

Teva concluded that since the approval of nilotinib was based upon an exemption granted under Article 8 (3) with regard to the first orphan product (imatinib), it should not be entitled to same scope of orphan exclusivity as imatinib and thus should not be considered a hurdle towards the approval of generics referencing imatinib.

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.

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.

Moussa is an inventor on a Georgetown University patent application for use of nilotinib for the treatment of neurodegenerative disease.

Moussa conducted the preclinical research that led to the discovery of nilotinib for the treatment of neuro - degenerative diseases, then partnered with Pagan for the clinical study.

Researchers say that use of nilotinib, in doses much smaller than those used to treat cancer, was welltolerated with no serious side effects.

Phase II study of nilotinib in melanoma harboring KIT alterations following progression to prior KIT inhibition.

Also, Georgetown holds an issued US patent on related technology for the use of nilotinib for the treatment of certain neurodegenerative diseases and has other pending patent applications in US and foreign jurisdictions.

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.

«Although TKIs such as the first - generation TKI imatinib mesylate (IM) and the second - generation TKIs dasatinib and nilotinib have markedly improved the prognosis of patients with chronic phase CML, a cure remains elusive.

(Moussa is listed as an inventor on a patent application that Georgetown University filed related to nilotinib and the use of other tyrosine kinase inhibitors for the treatment of neurodegenerative diseases.)

CML patients treated with nilotinib had fewer treatment - emergent BCR - ABL mutations than those treated with imatinib, and among patients who did have a mutation, those treated with nilotinib had reduced rates of progression to accelerated phase and blast phase of the disease.

In the proof of concept study, 12 patients received nilotinib, an FDA - approved drug for leukemia.

Druker said that Gleevec's long - term efficacy also offers a benchmark for comparative testing of two other similar kinase inhibitors, dasatinib and nilotinib, now underway.

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).