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June 11, 2014
17:19 EDTAZN, AMGNAmgen says Phase 2 study of brodalumab met primary endpoint
Amgen (AMGN) and AstraZeneca (AZN) announced that results from a Phase 2 study evaluating brodalumab in 168 patients with psoriatic arthritis were published in The New England Journal of Medicine. These data will also be presented at the 2014 European League Against Rheumatism Annual Congress in Paris on June 14.. Brodalumab is the only investigational treatment in development that binds to the interleukin-17 receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes. The study showed that treatment with brodalumab significantly improved signs and clinical symptoms associated with the disease, including tender and swollen joints, at 12 weeks as measured by a 20% improvement in the American College of Rheumatology response criteria. The study also showed that many patients continued to improve, and that the improvements were sustained, through the first 52 weeks of the study reported in NEJM. The study achieved its primary endpoint with both doses of brodalumab exhibiting superiority to placebo in ACR20 responses at week 12. These responses continued to improve through 24 weeks and were sustained through the first 52 weeks of the study.1 ACR response criteria are a measure of improvement in tender and swollen joints, as well as patient and physician global assessments of disease activity, pain, disability and inflammatory markers. A 20% improvement from baseline in ACR response rates is known as ACR20, a 50% improvement from baseline is known as ACR50 and a 70% improvement from baseline is known as ACR70.
News For AMGN;AZN From The Last 14 Days
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April 17, 2015
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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07:58 EDTAZNAstraZeneca's MedImmune, Immunocore announce new collaboration agreement
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April 15, 2015
18:56 EDTAMGNOn The Fly: After Hours Movers
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17:06 EDTAMGNAmgen confirms FDA approval of Corlanor
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16:40 EDTAMGNFDA approves Amgen's Corlanor to treat heart failure
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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.
07:14 EDTAZNEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
April 6, 2015
05:19 EDTAMGNAmgen announces EC approval of Vectibix in combination with Folfiri
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