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News Breaks
January 18, 2013
09:09 EDTBMY, AZNAstraZeneca, Bristol win CHMP backing for extended Onglyza use
The European Medicine Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the terms of the marketing authorization for the medicinal product Onglyza. The marketing authorization holder for the is Bristol-Myers Squibb (BMY) and AstraZeneca (AZN). The CHMP adopted a new indication as follows:" Onglyza is indicated as triple oral therapy in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control." Reference Link
News For AZN;BMY From The Last 14 Days
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April 16, 2015
09:12 EDTAZNAstraZeneca granted orphan status for melanoma treatment
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08:59 EDTBMYGene therapy companies could benefit from increased attention, says Roth Capital
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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
09:08 EDTBMYOn The Fly: Pre-market Movers
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07:41 EDTAZN, BMYEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
07:03 EDTBMYLexicon and Bristol-Myers select development candidate for neuropathic pain
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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
08:08 EDTBMYuniQure price target raised to $50 from $28 at Leerink
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08:06 EDTBMYBristol-Myers completes acquisition of Flexus Biosciences
Bristol-Myers Squibb Company announced that it has completed the previously announced planned acquisition of Flexus Biosciences, Inc. The transaction includes full rights to F001287, Flexus’ lead preclinical, small-molecule IDO1-inhibitor targeted for IND filing in the second half of 2015 and an IDO/TDO discovery program that includes its IDO-selective, IDO/TDO dual and TDO-selective compound libraries. A newly formed entity established by the current shareholders of Flexus will retain, from and after the closing, all non-IDO/TDO assets of Flexus including those related to Flexus’ Phase 1 FLT3 and CDK4/6 inhibitor, its earlier stage small-molecule Treg cancer immunotherapy programs, and its current personnel and facilities.
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 EDTBMY, AZNEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
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