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August 13, 2014
08:31 EDTAZNAstraZeneca says Phase 3 trials of lesinurad for gout met primary endpoints
AstraZeneca announced top-line results from CLEAR1, CLEAR2 and CRYSTAL, the pivotal Phase III clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor, as a combination therapy for the treatment of patients with symptomatic gout. Lesinurad is an investigational agent that inhibits the URAT1 transporter, increasing uric acid excretion and thereby lowering serum uric acid. In the CLEAR1 and CLEAR2 trials, both lesinurad 200mg and 400mg in combination with allopurinol met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <6.0mg/dL at month 6 compared to allopurinol alone. In the CRYSTAL trial, lesinurad 400mg in combination with febuxostat met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <5.0mg/dL at month 6 compared to febuxostat alone. Although lesinurad 200mg did not achieve statistical significance at month 6, this dose in combination with febuxostat, was superior to placebo plus febuxostat at all other time points. Results from these Phase III clinical trials will be submitted to a scientific meeting later in 2014. The company is proceeding with preparation of regulatory submissions for lesinurad 200mg combination therapy.
News For AZN From The Last 14 Days
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October 15, 2014
10:48 EDTAZNShire tanks with AbbVie calling board meeting over merger
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October 14, 2014
11:23 EDTAZNBIND Therapeutics and The Conference Forum hold a conference
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October 13, 2014
10:08 EDTAZNOn The Fly: Analyst Upgrade Summary
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09:21 EDTAZNOn The Fly: Pre-market Movers
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07:53 EDTAZNAstraZeneca upgraded to Buy from Hold at Jefferies
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05:27 EDTAZNAstraZeneca upgraded to Buy from Hold at Jefferies
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October 9, 2014
08:10 EDTAZNAstraZeneca reports Phase IIb study of benralizumab met primary endpoint
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October 7, 2014
07:48 EDTAZNSalix reinstated with a Buy at Jefferies
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October 6, 2014
07:32 EDTAZNAstraZeneca confirms AHA, ACC updated guideline
AstraZeneca confirmed that the American Heart Association and American College of Cardiology have updated the guideline for the management of patients with non–ST-elevation acute coronary syndromes. The guideline supports differentiation among currently available P2Y12 inhibitors, including ticagrelor, clopidogrel, and prasugrel, for these patients. BRILINTA is now preferred over clopidogrel for the management of NSTE-ACS patients who undergo an early invasive or ischemia-guided strategy or those who receive a coronary stent. This is the first time the AHA and ACC have recommended one P2Y12 over another in the treatment of acute coronary syndrome. The approved Prescribing Information for BRILINTA includes information about the approved uses for BRILINTA. BRILINTA has two Boxed WARNINGS, one for bleeding risk and the other for aspirin dose and reduced BRILINTA effectiveness. The Boxed WARNING on BLEEDING RISK states, like other antiplatelet agents, BRILINTA can cause significant, sometimes fatal, bleeding.

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