|June 12, 2014|
|16:20 EDT||NKTR, AZN||Nektar: U.S. AADPAC recommends no cardiovascular trial for pamora class|
Nektar Therapeutics (NKTR) reported that partner AstraZeneca (AZN) announced that the majority of US FDA Anesthetic and Analgesic Drug Products Advisory Committee members voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist class of drugs, which includes MOVANTIKTM, an investigational treatment for opioid-induced constipation for patients with chronic non-cancer pain. Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety. The FDA convened a meeting of the AADPAC to review the class of peripherally acting opioid receptor antagonists on June 11-12. The meeting assessed the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class, for the proposed indication of OIC in patients taking opioids for chronic non-cancer pain. The FDA is not bound by the Advisory Committee's recommendation, but takes its advice into consideration when reviewing applications for investigational medicines. The Prescription Drug User Fee Act date set by the FDA for MOVANTIK is September 16.
News For NKTR;AZN From The Last 14 Days
Check below for free stories on NKTR;AZN the last two weeks.
|August 22, 2014|
|10:07 EDT||AZN||Options with increasing implied volatility: ORPH EXAS AZN|
Subscribe for More Information
|05:19 EDT||AZN||Stocks with implied volatility movement; JRJC AZN|
Subscribe for More Information
|August 21, 2014|
|15:37 EDT||NKTR||Nektar: Baxter announces positive results from Phase 3 study of BAX 855 |
Nektar Therapeutics (NKTR) reports Baxter International (BAX) announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII treatment for hemophilia A based on ADVATE, which met its primary endpoint in reducing annualized bleed rates in the prophylaxis arm compared to the on-demand arm. Top-line results from the prospective, global, multi-center Phase 3 study demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and perioperative management for patients who were 12 years or older. Patients in a twice-weekly prophylaxis arm experienced a 95 percent reduction in median ABR as compared to those in the on-demand arm (1.9 vs. 41.5, respectively). BAX 855 was also effective in treating bleeding episodes, 96 percent of which were controlled with one or two infusions. The half-life of BAX 855 was 1.4 - 1.5 times that of ADVATE, consistent with the findings from the Phase 1 study. No patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported. The most common product-related adverse event was headache. Baxter expects to submit a Biologics License Application for BAX 855 to the U.S. Food and Drug Administration before the end of 2014 and will present additional data in the coming months. In addition to an ongoing continuation study for patients who have completed the pivotal trial, the company is initiating a Phase 3, prospective, open-label, multi-center study to evaluate the safety and efficacy of BAX 855 among 60 previously treated patients under the age of 12 with severe hemophilia A. Consistent with guidelines published by the European Medicines Agency that require a study in children less than 12 years of age prior to filing, Baxter expects to file a Marketing Authorization Application with the EMA upon the completion of the pediatric study
|09:54 EDT||AZN||Potential Pfizer, AstraZeneca deal seen around year-end, Reuters says|
Investors and analysts see Pfizer (PFE) making another attempt to acquire AstraZeneca (AZN) around year-end, even though talks between the two can resume on August 26 per British takeover rules, Reuters reports. Reference Link
|07:47 EDT||AZN||Pfizer looking at new targets, including Actavis, Bloomberg reports|
While it weighs another attempt to acquire AstraZeneca (AZN), Pfizer is considering other overseas alternatives, including Actavis (ACT), Bloomberg reports, citing people familiar with the matter. Pfizer prefers to reach a deal with AstraZeneca, and a move on another company is unlikely "anytime soon," Bloomberg adds, citing its sources. Shares of Actavis are rising 3%, or $6.65, to $230.01 in pre-market trading, while AstraZeneca is up 2% to $72.59. Reference Link
|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|
Subscribe for More Information