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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.
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April 24, 2015
06:07 EDTAZNAstraZeneca reiterates outlook for FY15
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06:06 EDTAZNAstraZeneca reports Q1 core EPS $1.08, consensus $1.05
Reports Q1 revenue $6.06B, consensus $5.95B. Reports Q1 Symbicort revenue $845M vs. $928M last year, Pulmicort revenue $286M vs. $263M last year, Crestor revenue $1.17B vs. $1.33B last year, Nexium revenue $644M vs. $930M last year.
05:39 EDTAZNCelgene announces strategic collaboration with AstraZeneca
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05:37 EDTAZNAstraZeneca signs co-development agreement with Innate Pharma
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April 23, 2015
15:01 EDTAZNNotable companies reporting before tomorrow's open
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08:25 EDTAZNJuno Therapeutics, MedImmune announce immuno-oncology trial collaboration
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April 22, 2015
08:04 EDTAZNBIND Therapeutics presents data on BIND-014, AZD2811 at AACR
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April 21, 2015
07:06 EDTAZNBina Tech, AstraZeneca announce collaborative agreement for GMS
Bina Technologies, a member of the Roche Group (RHHBY), and AstraZeneca (AZN) announced that they have entered into an agreement for AstraZeneca to become the first member to join the Bina Alliance Program and to further develop the Bina Genomic Management Solution. AstraZeneca will utilize the Bina GMS as an enterprise platform to support its development work across three main therapeutic areas: oncology, cardiovascular and metabolic disease, and respiratory, inflammation and autoimmunity. Bina’s proprietary technology enables translational and academic researchers to perform fast and scalable analyses to maximize the value of genomic data. Under the terms of the agreement, AstraZeneca will adopt Bina GMS globally to support enterprise genomic data analysis and management. Bina in turn will provide AstraZeneca with direct access to its scientific and engineering teams to further develop the Bina GMS for pharmaceutical applications.
April 20, 2015
06:02 EDTAZNClovis pullback on Astra data a buying opportunity, says Mizuho
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April 17, 2015
06:52 EDTAZNAstraZeneca granted FDA orphan drug designation for selumetinib
AstraZeneca announced that the FDA has granted orphan drug designation for the MEK inhibitor selumetinib, for the treatment of uveal melanoma, a rare disease in which cancer cells form in the tissues of the eye.
06:50 EDTAZNAstra reports median progression free survival of 13.5 months in AURA study
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April 16, 2015
09:12 EDTAZNAstraZeneca granted orphan status for melanoma treatment
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09:03 EDTNKTRBaxter submits application to Japan's MHLW for approval of BAX 855
Baxter International (BAX) announced that the company has submitted a new drug application to Japan’s Ministry of Health, Labour and Welfare for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII treatment based on ADVATE for patients over 12 years of age with hemophilia A. The submission follows the filing to the United States Food and Drug Administration in late 2014 and is based on positive results from a prospective, global, Phase 3 study of 137 previously treated patients. The results, presented during the European Association for Haemophilia and Allied Disorders meeting in February 2015, demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding episodes and routine prophylaxis for patients who were 12 years or older. Baxter continues to advance a continuation study for patients who completed the pivotal trial and a Phase 3 study among previously treated patients under the age of 12 with severe hemophilia A. Once the pediatric study has been completed, the company expects to file for marketing authorization with the European Medicines Agency in 2016 and intends to seek post-approval label expansion in the U.S. for previously-untreated pediatric patients. BAX 855 is based on ADVATE, a full-length FVIII molecule with more than 12 years of real-world experience. Through a collaboration with Nektar Therapeutics (NKTR), BAX 855 leverages proprietary pegylation technology designed to extend the duration of activity of the protein in the body. This proprietary technology has been used for over 10 years in a number of approved medicines that treat chronic or serious conditions.
07:58 EDTAZNAstraZeneca's MedImmune, Immunocore announce new collaboration agreement
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April 15, 2015
11:50 EDTAZNAstraZeneca initiated with a Buy at Societe Generale
07:41 EDTAZNEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
April 14, 2015
12:06 EDTAZNFDA panel accepts Onglyza's safety profile in 13-1 vote
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07:15 EDTAZNFDA Endocrinologic & Metabolic Drugs Advisory Committee holds a meeting
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April 13, 2015
08:58 EDTAZNMerck may have positive read through from briefing docs, says SunTrust
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08:54 EDTAZNAstraZeneca has negative read through from briefing docs, says SunTrust
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