May 7 Clinical Quick Takes: AZ, Merck, Osmotica, AlzeCure
AZ's Calquence meets in Phase III for CLL
AstraZeneca plc (LSE:AZN; NYSE:AZN) said an interim analysis of the Phase III ASCEND trial to treat relapsed or refractory chronic lymphocytic leukemia showed that Calquence acalabrutinib as monotherapy met the primary endpoint of improving progression-free survival (PFS) vs. Rituxan rituximab plus physician’s choice of idelalisib or bendamustine. Data from the Phase III ELEVATE-TN trial of the second-generation Btk inhibitor as first-line treatment of CLL are expected this year.
Merck's Belsomra meets in AD patients with insomnia
Merck & Co. Inc. (NYSE:MRK) said Belsomra suvorexant met the primary endpoint of increasing mean total sleep time from baseline to week 4 vs. placebo (73.4 vs. 45.2 minutes, p<0.005) in the Phase III MK-4305-061 trial to treat insomnia in patients with mild-to-moderate Alzheimer's disease dementia. The pharma said it will submit the data to FDA for inclusion in the drug's label. Merck markets the dual orexin receptor antagonist to treat insomnia characterized by difficulties with sleep onset and/or sleep maintenance...