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News Breaks
July 21, 2014
04:55 EDTONCS, ONCS, ONCS, INO, INO, INO, GSK, GSK, GSK, NVS, NVS, NVS, SNY, SNY, SNY, RHHBY, RHHBY, RHHBYInternational Society of DNA Vaccines to hold a conference
2014 DNA Vaccine Conference to be held in San Diego, California on July 21-23.
News For ONCS;INO;GSK;NVS;SNY;RHHBY From The Last 14 Days
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July 24, 2015
09:02 EDTNVSLigand says Revolade recommended by CHMP for EU approval for SAA
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07:21 EDTSNYRegeneron, Sanofi say CHMP recommends Euro approval of Praluent treatment
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September. The CHMP opinion was based on the benefit-risk profile of Praluent, following review of efficacy and safety data from more than 5,000 patients across 10 pivotal Phase 3 double-blind trials ranging from six months to two years. Clinical data from the ODYSSEY Phase 3 program show consistent, positive results in reducing LDL-C. The U.S. Food and Drug Administration has set a target action date of July 24 for the Biologics License Application of Praluent. The safety and efficacy of Praluent have not been fully evaluated by any other regulatory authority.
07:18 EDTSNYRegeneron and Sanofi's Praluent recommended for approval in Europe
Regeneron (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September.
07:17 EDTNVSNovartis combination therapy Tafinlar, Mekinist achieves regulatory milestones
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07:16 EDTSNYFDA PDUFA Date for Regeneron and Sanofi BLA for Praluent is July 24, 2015
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05:04 EDTGSKAgenus reports GSK Malaria vaccine receives positive opinion from CHMP of EMA
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July 23, 2015
08:18 EDTINOInovio, EORTC to collaborate on Phase 2 cervical cancer trial
Inovio announced it is collaborating with the European Organization for Research and Treatment of Cancer, or EORTC, to evaluate Inovio's immunotherapy, INO-3112, in combination with traditional chemo-radiotherapy for the treatment of patients with locally advanced stage cervical cancer. The trial, primarily funded by the EORTC, is expected to begin by the end of the year. A partnership with the EORTC will offer Inovio clinical trial efficiency and speed in recruiting patients in Europe and in obtaining and analyzing results. The EORTC encompasses all aspects of cancer research, from translational research and new drug development to large phase III clinical trials and meta-analyses. EORTC is the only organization which carries out clinical studies throughout Europe for all types of cancer. Collaboration with the EORTC also leverages their connections to a network of more than 2,500 pre-clinical scientists and oncologists in more than 300 hospitals in over 30 countries.
06:27 EDTRHHBYRoche CEO expects biosimilars in Europe by late 2017, Reuters reports
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05:46 EDTRHHBYRoche expects FY15 sales to grow low- mid-single digits
Expects FY15 core EPS to grow ahead of sales at constant exchange rates. Roche expects to further increase dividend in Swiss francs.
05:45 EDTRHHBYRoche reports 1H15 core EPS CHF 7.22 vs. 7.57 last year
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July 22, 2015
07:03 EDTNVSIgnyta names Bernard Parker as Chief Commercial Officer
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July 21, 2015
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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07:05 EDTRHHBYOphthotech names Shima as Chief Scientific Officer, Bjarke as CCO
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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%.
July 20, 2015
08:25 EDTNVSNovartis management to meet with JPMorgan
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07:33 EDTRHHBYInternational AIDS Society to hold a conference
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07:32 EDTNVSAlzheimer's Association to hold a conference
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05:13 EDTRHHBYRoche expands HIV Global Access Program
Roche announced an expansion to the HIV Global Access Program to include early infant HIV diagnostic testing for low and middle income countries. Roche, in partnership with the Joint United Nations Programme on HIV/AIDS, or UNAIDS, the Clinton Health Access Initiative, or CHAI, UNITAID, the U.S. President's Emergency Plan For AIDS Relief, or PEPFAR, and the Global Fund to fight AIDS, TB and Malaria, is committed to working with the Diagnostics Access Initiative by providing state-of-the-art solutions to achieve the 90-90-90 goal set forth by UNAIDS. Announced in 2014, the HIV Global Access Program is Roche's most recent addition to the AmpliCare Initiative, which launched in 2002 in South Africa.
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