|May 6, 2014|
|05:45 EDT||AZN||AstraZeneca announces FDA approval of Epanova |
AstraZeneca announced the FDA approved Epanova as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia. Epanova is the first FDA approved prescription omega-3 in free fatty acid form. The dosage of Epanova is 2 grams or 4 grams, making it the first prescription omega-3 to have a dosing option as few as two capsules once a day. It can be taken with or without food. The FDA approval was based on data from a clinical development program that included positive results from the Phase III EVOLVE trial, which examined the efficacy of Epanova in lowering triglycerides and other key lipid parameters in patients with very high triglycerides. The effect of Epanova on the risk of pancreatitis or on cardiovascular mortality and morbidity has not been determined.
News For AZN From The Last 14 Days
Check below for free stories on AZN the last two weeks.
|August 21, 2014|
|05:42 EDT||AZN||Illumina announces strategic partnership with AstraZeneca, Sanofi, Janssen |
Illumina (ILMN) announced it has formed collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing, or NGS,-based oncology test system. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine. Initial strategic partners include AstraZeneca (AZN), Janssen Biotech, a Johnson & Johnson (JNJ) company, and Sanofi (SNY). Illumina is working with the strategic partners to develop assays that detect and measure multiple variants simultaneously to support partners’ clinical trials, with the objectives of securing regulatory agency approvals and test commercialization. In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for “companion therapeutics.”
|August 19, 2014|
|07:01 EDT||AZN||DOJ closes investigation into PLATO Brilinta clinical trial, plans no action|
AstraZeneca today announced that it has received confirmation from the United States Department of Justice that it is closing its investigation into PLATO, a clinical trial with BRILINTA tablets. The government is not planning any further action. Pascal Soriot, CEO, said: “We welcome the Department of Justice’s decision not to pursue further action. We have always had absolute confidence in the integrity of the PLATO trial and we are proud of the important benefit BRILINTA offers to patients around the world suffering from acute coronary syndrome. As one of AstraZeneca’s growth platforms, we remain committed to delivering the full potential of this important medicine.” As part of our continued commitment to advancing the science behind cardiovascular medicine, AstraZeneca has initiated a clinical trial program for BRILINTA, its largest program involving more than 80,000 patients worldwide.
|August 18, 2014|
|07:57 EDT||AZN||Cambridge Healthtech Institute to hold a summit|
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
|August 14, 2014|
|12:01 EDT||AZN||Third Point gives quarterly update on stakes|
NEW STAKES: Rackspace (RAX), Finisar (FNSR), Amgen (AMGN), Ally Financial (ALLY), and AstraZeneca (AZN). INCREASED STAKES: Dollar General (DG) and Dow Chemical (DOW). DECREASED STAKES: FedEx (FDX), Hertz (HTZ), T-Mobile (TMUS) and Intrexon (XON). LIQUIDATED STAKES: Google Class A (GOOGL), Verizon (VZ) and Mondelez (MDLZ).
|August 13, 2014|
|08:31 EDT||AZN||AstraZeneca 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.
|August 12, 2014|
|05:58 EDT||AZN||Stocks with implied volatility movement; P AZN|
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|August 7, 2014|
|06:13 EDT||AZN||Dynavax says AZD1419 Phase 1 study met secondary endpoints|
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