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Stock Market & Financial Investment News

News Breaks
June 19, 2014
14:52 EDTNKTR, AZNAstraZeneca says data demonstrate naloxegol improved OIC in pain patients
AstraZeneca announced that the New England Journal of Medicine has published results of two pivotal Phase III studies KODIAC-4 and KODIAC-5 of naloxegol, an investigational treatment for opioid-induced constipation, or OIC. Primary endpoint data from the KODIAC-4 and -5 studies showed that more OIC patients treated with naloxegol 25 mg had a consistent response of increased spontaneous bowel movements through 12 weeks of treatment compared to placebo. The 12.5 mg dose in KODIAC-5 did not show statistical significance for the primary endpoint. The 25 mg dose also demonstrated a higher response rate through 12 weeks of treatment compared to placebo in patients with laxative inadequate response, a secondary endpoint. Results for an additional secondary endpoint showed that patients taking naloxegol 25 mg in the KODIAC-4 and KODIAC-5 studies were likely to have a first post-dose spontaneous bowel movement 25-30 hours sooner than placebo, respectively. A New Drug Application for naloxegol was accepted by the U.S. Food and Drug Administration in November 2013. MOVANTIK is the proposed proprietary name for naloxegol. Nektar Therapeutics (NKTR) is partnering with AstraZeneca on naloxegol.
News For AZN;NKTR From The Last 14 Days
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December 19, 2014
15:18 EDTAZNAstraZeneca confirms FDA approval of LYNPARZA
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12:12 EDTAZNMyriad Genetics receives FDA approval of BRACAnalysis CDx
Myriad Genetics (MYGN) announced that it has received approval from the U.S. FDA for BRACAnalysis CDx to be used as the only companion diagnostic in conjunction with AstraZeneca's (AZN) drug Lynparza. Lynparza is the first poly ADP-ribose polymerase inhibitor for patients with germline mutations in BRCA1/2 advanced ovarian cancer who have had three or more lines of chemotherapy. BRACAnalysis CDx is Myriad's first FDA-approved companion diagnostic for use with a novel PARP inhibitor. BRACAnalysis CDx is a highly accurate molecular companion diagnostic test that identifies deleterious or suspected deleterious mutations in the BRCA1 and BRCA2 genes, using DNA obtained from a blood sample. BRACAnalysis CDx was proven in clinical studies to effectively identify patients with BRCA mutations who would be candidates for Lynparza. The approval of BRACAnalysis CDx demonstrates Myriad's commitment to developing companion diagnostics and is the culmination of an intensive, multiyear scientific collaboration with AstraZeneca to advance personalized medicine for women with ovarian cancer.
11:45 EDTAZNFDA approves Lynparza to treat advanced ovarian cancer
The U.S. FDA granted accelerated approval to Lynparza, a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test. Lynparza is marketed by AstraZeneca Pharmaceuticals, based in Wilmington, Delaware. Reference Link
December 15, 2014
07:33 EDTAZNAdvaxis announces FDA acceptance of INDA to commence clinical trials of ADXS-HPV
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December 11, 2014
18:03 EDTNKTRNektar reports data from Phase 3 BEACON study of NKTR-102
Nektar Therapeutics presented biomarker data from a sub-study of the Phase 3 BEACON study of etirinotecan pegol (NKTR-102) which collected and analyzed circulating tumor cell samples from patients in the study. A total of 80% of the 852 patients enrolled in the BEACON trial participated in the CTC sub-study. Among the 627 patients who participated and had evaluable baseline samples, CTCs were detected in 97% of these samples. For the 611 evaluable baseline patient samples which yielded CTCs, potential NKTR-102 target-specific pharmacodynamic biomarkers were detected in the majority of samples. The pharmacodynamic biomarkers assessed in the CTC sub-study were chosen because of their potential ability to predict response to topoisomerase inhibition as well as to measure chemo-sensitivity in metastatic cancer patients
16:03 EDTAZNAmgen, AstraZeneca to present results from Phase 3 plaque psoriasis study
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08:05 EDTNKTRFDA Pediatric Oncologic Subcommittee to hold a meeting
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07:28 EDTAZNCBI to hold a summit
2nd Specialty Data Optimization Summit is being held in Philadelphia on December 11.
December 9, 2014
09:10 EDTAZNARIAD takeover rumors rekindled, Independent says
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08:02 EDTAZN, NKTRMoventig approved in EU for opioid-induced constipation
Nektar (NKTR) reported partner AstraZeneca (AZN) announced that MOVENTIG has been granted Marketing Authorisation by the European Commission for the treatment of opioid-induced constipation in adult patients who have had an inadequate response to laxative. MOVENTIG is the first once-daily oral peripherally-acting mu-opioid receptor antagonist to be approved in the European Union.
07:44 EDTNKTR, AZNAmerican Association for Cancer Research to hold a symposium
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December 8, 2014
07:29 EDTNKTRUBS to hold investor trip
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07:18 EDTNKTRUBS to hold investor trip
2014 Annual West Coast Investor Trip travels on the West Coast on December 8-10.
07:05 EDTAZNInnocoll appoints Tony Zook as CEO
Innocoll AG (INNL) announced that Tony Zook, formerly executive vice president, Global Commercial Operations, at AstraZeneca (AZN), has been appointed CEO effectively immediately. Michael Myers, will continue with the company as head of Portfolio Operations.
December 5, 2014
09:49 EDTAZNUBS European pharmaceuticals analysts holds analyst/industry conference call
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