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Stock Market & Financial Investment News

News For OPTR;CBST;AZN;GSK From The Last 14 Days
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April 30, 2015
16:59 EDTGSKGlaxoSmithKline, Theravance announce FDA approval of Breo Ellipta
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15:20 EDTGSKGlaxo says FDA issued CRL on use of Breo Ellipta in patients aged 12-17
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15:17 EDTGSKGlaxoSmithKline says FDA approves BREO ELLIPTA for adults with asthma
GlaxoSmithKline (GSK) and Theravance (THRX) announced that the FDA has approved BREO ELLIPTA for the once-daily treatment of asthma in patients aged 18 years and older. Breo Ellipta is not indicated for the relief of acute bronchospasm. Breo is a fixed-dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist vilanterol. Two strengths, 100/25mcg and 200/25mcg, have been approved in the US for use in asthma, administered once-daily using the Ellipta dry powder inhaler.
07:21 EDTGSKFDA PDUFA Date for Theravance BREO ELLIPTA is April 30, 2015
April 29, 2015
10:39 EDTAZNCiti analyst says outlook still strong for big pharma
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07:18 EDTAZNAstraZeneca says FDA grants priority review for new indication of Brilinta
AstraZeneca announced that the FDA has accepted a supplemental new drug application and granted Priority Review for BRILINTA tablets for patients with a history of heart attack. The sNDA is based on the results of the PEGASUS-TIMI 54 study, a large-scale outcomes trial in more than 21,000 patients that investigated ticagrelor tablets plus low dose aspirin, compared to placebo plus low dose aspirin, for the chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study enrollment. The Prescription Drug User Fee Act goal date will be in the third quarter of 2015. A Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. PEGASUS-TIMI 54 is part of AstraZeneca’s PARTHENON program. The PLATO study, involving over 18,000 patients, was the first study in the program and is the basis on which ticagrelor has been approved in over 100 countries and included in 12 major ACS treatment guidelines globally. Further ongoing PARTHENON studies are assessing ticagrelor for the prevention of cardiovascular events in patients with peripheral arterial disease, ischemic stroke or transient ischemic attack, and in patients with diabetes and coronary atherosclerosis. BRILINTA is not approved for secondary prevention of atherothrombotic events in patients with a history of heart attack beyond one year or for the prevention of cardiovascular events in patients with peripheral arterial disease, stroke, diabetes or atherosclerosis.
April 27, 2015
10:04 EDTGSKHigh option volume stocks
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08:46 EDTGSKAgenus data positive, says JMP Securities
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08:41 EDTAZN, GSKTelegraph discusses potential takeover of GSK by Pfizer
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06:19 EDTAZN, GSKPharmceutical companies buy drugs and raises prices, WSJ reports
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April 24, 2015
07:11 EDTGSKAgenus: GSK's RTS,S vaccine showed statistically significant results in study
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06:19 EDTAZNAstraZeneca says smaller M&A deals more realistic, Reuters reports
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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.
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