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News Breaks
January 18, 2013
09:09 EDTAZN, BMYAstraZeneca, 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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November 13, 2014
07:03 EDTAZNAstraZeneca initiates development program for Brilinta reversal agent
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06:09 EDTBMYBristol-Myers' oral daclatasvir regimen shows high cure rates for hepatitis C
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06:05 EDTBMYBristol-Myers' daclatasvir reports high cure rates for genotype 3 hepatitis C
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05:34 EDTAZNAstraZeneca, Isis Pharmaceuticals to co-develop oligonucleotide delivery methods
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04:23 EDTBMYBristol-Myers downgraded to Equal Weight from Overweight at Morgan Stanley
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November 12, 2014
11:17 EDTAZN, BMYLeerink major pharma & biotech analysts hold analyst/industry conference call
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07:35 EDTAZNAdvaxis submits IND application for ADXS-HPV Phase 1/2 study, MEDI4736
Advaxis (ADXS) announced that the company has submitted an Investigational New Drug application, or IND, to the FDA to conduct a Phase 1/2 study of ADXS-HPV alone or in combination with MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, for the treatment of advanced, recurrent or refractory human papillomavirus, or HPV,-associated cervical cancer and HPV-associated head and neck cancer. This follows the press release issued in July announcing the clinical trial collaboration between Advaxis and MedImmune, the global biologics research and development arm of AstraZeneca (AZN).
November 11, 2014
16:14 EDTBMYLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including JAK inhibitors, novel Jakafi combinations for Myelofibrosis and developing compounds on an Analyst/Industry conference call to be held on November 17 at 10 am.
16:05 EDTAZNAmgen, AstraZeneca say Phase 3 brodalumab study met endpoints
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15:43 EDTAZN, BMYLeerink major pharma & biotech analysts hold analyst/industry conference call
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November 10, 2014
15:53 EDTBMYCredit Suisse to hold a conference
Healthcare Conference is being held in Scottsdale, Arizona on November 10-13 with webcasted company presentations to begin on November 11 at 10:30 am; not all company presentations may be webcasted. Webcast Link
November 9, 2014
15:45 EDTBMYBristol-Myers announces daclatasvir data from the UNITY trial program
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12:40 EDTBMYBristol-Myers announces data from ALLY trial investigating daclatasvir
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11:45 EDTBMYBristol-Myers announces data from the UNITY trial program
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November 6, 2014
15:13 EDTBMYAmerican Association for Study of Liver Diseases to hold a meeting
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06:35 EDTAZNAstraZeneca CEO says tax revisions cripple new Pfizer offer, Reuters says
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05:51 EDTAZNAstraZeneca targets 2015 EPS to be no less than low end of 2014 range
AstraZeneca said, "For 2015, the Company plans to continue to selectively invest in its growth platforms and accelerating pipeline while managing overall costs. Assuming current exchange rates, the Company is targeting Core EPS for 2015 to be no less than the lower end of the range of the upgraded guidance for Core EPS for 2014 at actual exchange rates. Guidance for 2015 is expected to be provided with 2014 results on 5 February 2015."
05:50 EDTAZNAstraZeneca raises 2014 revenue growth outlook to low single digits at CER
AstraZeneca said 2014 revenue is now expected to increase in low single digits at CER, an upgrade to its previous guidance for revenue to be in line with 2013 at CER. The guidance assumes no U.S. Nexium generic in 2014. It added, "In light of the increase in revenue expectations for the year, the Company is accelerating its investments in its growth platforms and expanding pipeline. Core EPS for 2014 is now expected to decrease at around 10% at CER; better than anticipated in previous guidance. In addition, Core EPS for 2014 at actual exchange rates is expected to be impacted negatively by currency by around 5%, assuming current exchange rates."
05:49 EDTAZNAstraZeneca reports Q3 core EPS $1.05, consensus $1.04
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05:37 EDTAZNAegerion acquires Myalept from AstraZeneca for $325M
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