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News Breaks
February 2, 2014
20:16 EDTAZN, BMY, SNYFDA's approval of AstraZeneca's Brilinta questioned, WSJ says
The FDA's approval of AstraZeneca's (AZN) anticlotting drug Brilinta is being called into question as a medical professor at Johns Hopkins Hospital who specializes in such drugs, maintains the study numbers may have been manipulated, says the Wall Street Journal. AstraZeneca has marketed Brilinta as a potential "mass-market blockbuster" that is more effective than Plavix which is co-marketed by Sanofi (SNY) and Bristol-Myers Squibb (BMY), added the Wall Street Journal. Reference Link
News For AZN;SNY;BMY From The Last 14 Days
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January 27, 2015
12:54 EDTAZNBox, Inc. lands AstraZeneca contract to service 51,000 users, Re/code reports
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07:37 EDTBMYBristol-Myers sees FY15 EPS $1.55-$1.70, consensus $1.71
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07:31 EDTBMYBristol-Myers reports Q4 EPS 46c, consensus 41c
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January 26, 2015
15:40 EDTBMYNotable companies reporting before tomorrow's open
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15:24 EDTAZNTeva confirms U.S. approval of AstraZeneca's Nexium generic
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11:29 EDTBMYBristol-Myers January weekly volatility increases into Q4 and outlook
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05:14 EDTSNYRegeneron, Sanofi announce BLA for Praluent accepted for priority review by FDA
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the Biologics License Application, or BLA, for Praluent, alirocumab. Under the Prescription Drug User Fee Act, or PDUFA, the goal for a priority review is six months, for a target action date of July 24. Alirocumab is an investigational monoclonal antibody targeting PCSK9 that is intended for the treatment of patients with hypercholesterolemia. The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years. Earlier this month, the companies announced that the European Medicines Agency accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
January 22, 2015
08:49 EDTBMYBristol-Myers price target raised to $70 from $63 at SunTrust
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05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
12:30 EDTAZNGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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10:16 EDTSNY, AZN, BMYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
January 20, 2015
16:34 EDTBMYBristol-Myers appoints Giovanni Caforio CEO
Bristol-Myers Squibb announced a number of leadership changes approved by its board of directors and effective at the close of the annual Shareholders’ Meeting on May. Giovanni Caforio, M.D. will become CEO of the company. Lamberto Andreotti will become executive chairman of the board of directors on May 5 and will continue to serve as chairman after his retirement on August 3. James M. Cornelius, 71, has chosen not to stand for re-election as non-executive chairman and will retire from the board. Togo D. West, Jr., 72, will become the lead independent director on the company’s board.
January 14, 2015
07:37 EDTAZNJPMorgan to hold a conference
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07:03 EDTAZNAstraZeneca says Pegasus-TIMI 54 study met primary efficacy endpoint
AstraZeneca announced that the PEGASUS-TIMI 54 study, a large scale outcomes trial involving over 21,000 patients, successfully met its primary efficacy endpoint. The study assessed BRILINTA tablets at either 60mg twice daily or 90mg twice daily plus low-dose aspirin for the secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study start. The primary efficacy endpoint was a composite of cardiovascular death, myocardial infarction or stroke. Preliminary analysis did not reveal any unexpected safety issues. Full evaluation of the data is ongoing. The PEGASUS-TIMI 54 study investigated two different doses of ticagrelor on a background of low dose aspirin versus placebo plus low dose aspirin, in patients aged 50 and older with a history of heart attack and one additional CV risk factor. The study was designed to better understand the management of patients more than 12 months after their heart attack, who remain at high risk for major thrombotic events. Complete results from the PEGASUS-TIMI 54 study will be submitted to a scientific meeting in 2015 and pending further analysis, AstraZeneca plans to file this data with regulatory health authorities. The PEGASUS-TIMI 54 study is part of AstraZeneca’s PARTHENON program. The PLATO study, involving over 18,000 ACS 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 investigating ticagrelor for the prevention of cardiovascular events in patients with peripheral arterial disease, ischaemic stroke or transient ischaemic 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 PAD, stroke, diabetes or atherosclerosis.
07:03 EDTAZNAstraZeneca says Pegasus-TIMI 54 study met primary efficacy endpoint
January 13, 2015
14:15 EDTBMYBristol-Myers treatment of acute myeloid leukemia gets FDA orphan designation
According to a post on the FDA's website, Bristol-Myers' treatment of acute myeloid leukemia, ulocuplumab, received orphan designation. Reference Link
12:27 EDTBMYDOJ, EPA report proposed settlement regarding cleanup of Warren County, NJ site
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08:09 EDTBMYBristol-Myers price target raised to $72 from $66 at Leerink
Leerink raised its price target for Bristol-Myers to $72 saying the earlier stop of the Opdivo trial affirms the drug's potential survival benefits across multiple cancers. Leerink says it now has increased confidence in positive readouts for Bristol's upcoming survival studies in non-squamous non-small cell lung cancer and kidney cancer. The firm reiterates an Outperform rating on the stock.
08:05 EDTBMYBristol-Myers Eli Lilly enter clinical collaboration pact for Opdivo combo
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07:42 EDTBMYJPMorgan to hold a conference
33rd Annual Healthcare Conference is being held in San Francisco on January 12-15 with webcasted company presentations to begin on January 13 at 10:30 am; not all company presentations may be webcasted. Webcast Link

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