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Genzyme Corporation announced results today from its CLASSIC I phase 3 trial comparing Clolar® (clofarabine) in combination with the chemotherapy agent cytarabine (ara-c) to cytarabine plus placebo in relapsed-refractory adult acute myeloid leukemia (AML). Although the study did not show a difference between the arms in the primary endpoint of overall survival, the Clolar combination demonstrated statistical significance across all four pre-specified secondary efficacy endpoints: overall remission rate; complete remission rate; event-free survival; and four-month event free survival.

Bristol-Myers Squibb Company and AstraZeneca announced results from a randomized, double-blind Phase 3 clinical study in adults with type 2 diabetes inadequately controlled on metformin therapy alone. The study demonstrated dapagliflozin was non-inferior compared to glipizide (sulphonylurea) in improving glycosylated hemoglobin levels (HbA1c) when added to existing metformin therapy during a 52-week treatment period. The study also demonstrated that dapagliflozin plus metformin achieved significant reductions in key efficacy secondary endpoints: reduction in total body weight from baseline, compared with a weight gain on glipizide plus metformin therapy and a reduced number of patients reporting one or more hypoglycemic events. Treatments were titrated during the first 18 weeks, up to 10 mg/day for dapagliflozin plus metformin (median dose 10 mg/day) or 20 mg/day for glipizide (median dose 20 mg/day). Results from the study were presented at the 46th European Association for the Study of Diabetes (EASD) Annual Meeting.

Boehringer Ingelheim announced today that the European Commission confirmed the positive opinion of the European Medicines Agency (EMA) approving TWYNSTA®. TWYNSTA® is indicated for the treatment of hypertension in adults whose blood pressure is not adequately controlled on amlodipine or as replacement therapy in adult patients receiving telmisartan and amlodipine from separate tablets containing the same component doses.

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