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Stock Market & Financial Investment News

News Breaks
February 10, 2014
07:55 EDTPFE, PFE, NVS, NVS, BAYRY, BAYRYFDA to hold a joint committee meeting
The Arthritis Advisory and Drug Safety & Risk Management Advisory Committees, along with Pfizer, Novartis and Bayer, discuss data and analyses published in 2006 or later that are relevant to further understanding the relationship between nonsteroidal anti-inflammatory drugs (NSAIDs) and cardiovascular thrombotic risk that is currently described in NSAID class labeling in a meeting being held at FDA Silver Spring, Maryland offices on February 10 at 8 am. Webcast Link
News For PFE;NVS;BAYRY From The Last 14 Days
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October 23, 2014
18:52 EDTPFEOn The Fly: After Hours Movers
UP AFTER EARNINGS: Rubicon Project (RUBI), up 19.2%... KLA-Tencor (KLAC), up 15.8%... Gigamon (GIMO), up 13.5%... Maxwell (MXWL), up 11.3%... Qlik Technologies (QLIK), up 9.8%... NetSuite (N), up 5.5%... Microsoft (MSFT), up 3.3%... Juniper Networks (JNPR), reverses in after-hours trading and is up 1.4% after reporting third quarter results and announcing a $1.1B increase to the company's share repurchase authorization. ALSO HIGHER: Vitae Pharmaceuticals (VTAE), up 38.6% following positive top-line results from two Phase 1 clinical trials of BI1181181/VTP-37948... Pfizer (PFE), up 1.8% after announcing a new $11B share repurchase program. DOWN AFTER EARNINGS: Amazon.com (AMZN), down 10.7%... Synaptics(SYNA), down 12.7%... Pandora (P), down 6.8%... Lattice Semiconductor (LSCC), down 5.6%... Maxim Integrated (MXIM), down 5.8%. ALSO LOWER: DryShips (DRYS), down 16.5% after filing an automatic common stock shelf... NPS Pharmaceuticals (NPSP), down 7.9% following PDUFA date for Natpara extended three months to January 24... GoPro (GPRO), down 2.8% after being initiated with an Underperform at Oppenheimer.
18:18 EDTPFEGlenview Capital acquires stake in Actavis, Bloomberg reports
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16:17 EDTPFEPfizer announces new $11B share repurchase program
The board of directors also authorized a new $11B share repurchase program to be utilized over time. This new program is in addition to the $1.3B of authorization remaining under the company’s current share repurchase program.
11:57 EDTNVSNovartis management to meet with Jefferies
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08:15 EDTPFEPfizer wins SUTENT patent case In Delaware District Court
Pfizer (PFE) announced today that the U.S. District Court for the District of Delaware upheld its basic patent and the L-malate salt patent covering SUTENT capsules. This decision, which is subject to appeal, affirms Pfizer’s right to exclusively provide sunitinib malate as SUTENT to patients through the term of the patent, which expires in 2021. Pfizer filed suit in June 2010 after Mylan (MYL) applied to the U.S. Food and Drug Administration to market a generic version of SUTENT prior to the expiration of the patents covering sunitinib malate and its uses. After a four-day trial, the Court agreed that Mylan infringed the valid patents covering SUTENT.
05:21 EDTNVSNovartis AIN457 meets primary endpoint in two Phase III studies in AS
Novartis announced that AIN457 met primary and key secondary endpoints in two pivotal Phase III studies, MEASURE 1 and MEASURE 2, in patients with ankylosing spondylitis, or AS. Key endpoints included improvements in signs and symptoms of the disease versus placebo and associated improvements in physical function and quality of life. Secukinumab is an investigational medicine that works by stopping the action of interleukin- 17A, a protein that is central to the development of inflammatory diseases, including AS. MEASURE 1 and MEASURE 2 enrolled a combined total of approximately 600 patients. Detailed results of the studies will be presented at an upcoming medical congress. Joint regulatory applications for secukinumab in AS and PsA are planned for 2015. This follows the secukinumab global regulatory applications for moderate- to-severe plaque psoriasis which were filed in October 2013 with regulatory decisions anticipated in late 2014 or early 2015.
October 22, 2014
13:37 EDTBAYRYPE firms may bid on Bayer's MaterialScience unit, Reuters says
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07:44 EDTNVSGlaxoSmithKline backs FY14 view for core EPS 'broadly similar' to FY13
GlaxoSmithKline (GSK) continues to expect full year 2014 core EPS to be broadly similar to 2013 at CER and on ex-divestment basis. Glaxo says its proposed 3-part transaction with Novartis (NVS) is on track for completion in 1H15.
October 21, 2014
07:15 EDTNVS, PFEFDA to hold workshop on breast cancer drug development
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07:06 EDTPFEFierce Biotech to hold a breakfast meeting
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October 20, 2014
15:09 EDTNVSNovartis reports FDA advisory committee recommends approval of secukinumab
Novartis announced the Dermatologic and Ophthalmic Drugs Advisory Committee to the FDA voted unanimously to support the approval of AIN457, or secukinumab, a selective interleukin-17A inhibitor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. A Biologics License Application for secukinumab is currently under FDA review with an anticipated action date in early 2015.
07:47 EDTPFEPfizer less likely to renew Astra pursuit after Shire deal breakdown, FT says
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07:26 EDTNVSFDA Dermatologic & Ophthalmic Drugs Advisory Committee to hold a meeting
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07:15 EDTPFEAmerican Academy of Child & Adolescent Psychiatry to hold annual meeting
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07:12 EDTPFECongress of Neurological Surgeons to hold annual meeting
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07:11 EDTPFE, BAYRYAmerican Society for Reproductive Medicine to hold annual meeting
2014 Annual Meeting of ASRM is being held in Honolulu on October 18-22.
07:10 EDTPFEAmerican Society of Human Genetics to hold annual meeting
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October 17, 2014
16:41 EDTPFEPfizer confirms FDA labeling approval for EMBEDA capsules
Pfizer announced that the FDA has approved an updated label for EMBEDA extended-release capsules, for oral use to include abuse-deterrence studies. The updated label states that EMBEDA has properties that are expected to reduce abuse via the oral and intranasal routes when crushed. However, abuse of EMBEDA by these routes is still possible. The updated label also includes data from a human abuse potential study of intravenous, or IV, morphine and naltrexone to simulate crushed EMBEDA. However, it is unknown whether the results with simulated crushed EMBEDA predict a reduction in abuse by the IV route until additional postmarketing data are available. EMBEDA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Pfizer expects EMBEDA will be available in the U.S. in early 2015.
16:30 EDTPFEFDA approves new labeling from Embeda extended-release capsules
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14:50 EDTNVSBARDA asks labs to ramp up Zmapp production, Reuters says
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