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Stock Market & Financial Investment News

News For MRK;PFE;GSK;JNJ;BMY;NVS;SHPG;ABT;CELG;SNY From The Last 14 Days
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July 22, 2015
07:04 EDTMRKMerck's Keytruda approved by EU for treatment of advanced melanoma in adults
Merck announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, for the treatment of advanced melanoma in adults. The European Commission approval of pembrolizumab is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. Pembrolizumab received European Commission regulatory approval based on Phase 3 data which showed it is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma. Today’s approval allows marketing of pembrolizumab in all 28 EU member states at the approved dose of 2 mg/kg every three weeks. The European Commission’s approval is based on data from three studies -- KEYNOTE-001, KEYNOTE-002 and KEYNOTE-006. These studies evaluated the efficacy and safety of pembrolizumab in advanced melanoma patients – across treatment lines, prognostic factors, tumor characteristics, and BRAF mutational status – and established 2 mg/kg every three weeks as the approved dose.
07:03 EDTNVSIgnyta names Bernard Parker as Chief Commercial Officer
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06:05 EDTMRKMerck, Ablynx expand immuno-oncology collaboration
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July 21, 2015
15:02 EDTABTNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's open, with earnings consensus, include Coca-Cola (KO), consensus 60c... Boeing (BA), consensus $1.42... Abbott Laboratories (ABT), consensus 50c... Thermo Fisher Scientific (TMO), consensus $1.78... EMC (EMC), consensus 41c... Illinois Tool Works (ITW), consensus $1.28... St. Jude Medical (STJ), consensus $1.00... Northern Trust (NTRS), consensus 96c... Check Point Software (CHKP), consensus 95c... Polaris Industries (PII), consensus $1.58... Interpublic Group (IPG), consensus 27c... New York Community Bancorp (NYCB), consensus 26c... B/E Aerospace (BEAV), consensus 76c... Owens Corning (OC), consensus 54c... Knight Transportation (KNX), consensus 37c.
14:03 EDTBMYBristol-Myers: Data from Phase IIa study support further evaluation of BMS955176
Bristol-Myers Squibb announced additional Phase IIa proof-of-concept data for BMS-955176, a novel investigational agent designed to prevent the maturation of HIV-1. The study findings, which are being presented in a late-breaking oral presentation at the 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, confirmed the antiretroviral activity of BMS-955176 when administered with atazanavir and support further development of the second-generation HIV-1 maturation inhibitor. BMS-955176 is designed to inhibit one of the last steps of the HIV-1 viral lifecycle, resulting in the release of immature non-infectious HIV-1 particles. As part of a multi-part proof-of-concept study, a two-drug combination of BMS-955176 plus atazanavir had a maximum median change in HIV-1 RNA of -2.23 log10 c/mL from baseline through study discharge. The standard of care control of atazanavir 300 mg and ritonavir 100 mg plus tenofovir disoproxyl fumarate 300 mg plus emtricitabine 200 mg in a fixed dose combination had a maximum median change in HIV-1 RNA of -2.39 log10 c/mL from baseline through study discharge. In addition, a lower dose of BMS-955176 plus atazanavir and ritonavir had a similar maximum median change in HIV-1 RNA of -2.20 log10 c/mL. Length of therapy for all treatment groups was 28 days. Study endpoints included change in HIV-1 RNA from baseline to Day 28 and from baseline to the end of the study and safety. Data from Part A and Part B of the Phase IIa proof-of-concept study support the further evaluation of BMS-955176 in novel treatment regimens such as nucleos(t)ide- and booster-sparing regimens to address key unmet needs for HIV-1 treatment-experienced patients. Two Phase IIb studies have started in 2015: a traditional dose-finding study in treatment-naive patients and a second Phase IIb study to evaluate a nucleos(t)ide- and booster-sparing regimen in treatment-experienced patients.
12:47 EDTSNYPiper confident in Regeneron approval by Friday
After Amgen's (AMGN) Repatha received marketing authorization in Europe, making it the first of the anti-PCSK9 antibody to be approved worldwide, Piper Jaffray analyst Edward Tenthoff expressed confidence that Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent will be approved by Friday's FDA action date. Tenthoff believes Praluent will eventually be a blockbuster drug, but anticipates the launch to be slow. He keeps a Neutral rating on Regeneron with a $484 price target.
11:49 EDTNVSNovartis may sell Amgen's cancer drug as soon as September, Bloomberg says
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11:03 EDTCELGCelgene treatment of pediatric Crohn's disease receives FDA orphan designation
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09:02 EDTBMYBristol-Myers Squibb receives FDA breakthrough designation for HIV-1 inhibitor
Bristol-Myers Squibb announced that the FDA has granted Breakthrough Therapy Designation to the investigational compound BMS-663068 when used in combination with other antiretroviral, or ARV, agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor. The attachment inhibitor is designed to work differently than entry inhibitors, a current class of drugs that targets co-receptors’ activity or fusion after HIV attaches to the CD4+ host cell. BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus’ initial interaction with immune cells entirely, and thus blocks its entry into the cell.
08:04 EDTPFEPfizer launches Caltrate Bone & Joint Health supplement
Pfizer Consumer Healthcare announced the launch of Caltrate Bone & Joint Health, a 3-in-1, triple action product that delivers UC-II, an exclusive form of collagen, to support healthy cartilage and promote joint flexibility, calcium and vitamin D3, to nourish strong and healthy bones, and vitamin C and minerals to support collagen production for healthy bones and skin.
06:29 EDTCELGCelgene price target raised to $160 from $147 at Piper Jaffray
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06:24 EDTCELGPiper expects 'stronger, bolder' move from Biogen
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05:20 EDTNVSNovartis backs FY15 revenue guidance of up mid-single digit
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05:17 EDTNVSNovartis reports Q2 core EPS $1.27, consensus $1.24
Reports Q2 revenue $12.7B, consensus $12.44B. Further strengthening of USD impacted sales by -11% and core operating income by -13%. Growth Products, an indicator of the rejuvenation of the portfolio, contributed 35% of continuing operations net sales in Q2, and were up 24%. In Pharmaceuticals, Growth Products contributed 44% of division net sales in the quarter, and sales for these products were up 38%.
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