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News Breaks
June 12, 2014
16:20 EDTAZN, NKTRNektar: 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
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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 Japanís 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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April 10, 2015
10:36 EDTAZNAstraZeneca trades lower, levels to watch
Shares are down less than 1% to $69.54 at time of writing. At that price the stock is just above the 50-day moving average at $69.12. Since May of last year, price has oscillated around the 50-day, with the average acting as the approximate center line. Support below the 50-day is at $68.24.
09:25 EDTAZNFDA staff say analysis suggests Onglyza may increase risk of death
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April 9, 2015
09:25 EDTAZNPiper Jaffray pharmaceuticals analysts hold an analyst/industry conference call
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April 8, 2015
06:06 EDTAZNInovio selected by DARPA to lead $45M Ebola prevention program
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April 7, 2015
16:12 EDTAZNRegulus up 5% after RG-125 selected as clinical candidate by AstraZeneca
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16:12 EDTAZNRegulus RG-125 selected as clinical candidate by AstraZeneca
Regulus Therapeutics (RGLS) announced the selection of RG-12, a GalNAc-conjugated anti-miR targeting microRNA-103/107, or miR-103/107, for the treatment of Non Alcoholic Steatohepatitis, or NASH, in patients with type 2 diabetes/pre-diabetes, as a clinical candidate by AstraZeneca (AZN) under the companies' strategic alliance to discover, develop and commercialize microRNA therapeutics. RG-125 is the first compound from the alliance to be selected for clinical development by AstraZeneca. In connection with the candidate selection, AstraZeneca will pay Regulus $2.5M and will assume development of the program following acceptance of an Investigational New Drug application. In the near term, Regulus and AstraZeneca plan to submit key preclinical data on the RG-125 program to be presented at a scientific meeting later this year and expect to initiate a Phase I study of RG-125 in humans by the end of 2015.
11:10 EDTNKTRNektar management to meet with Jefferies
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07:14 EDTAZNEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.

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