Articles From: European CHMP Adopts Positive Opinion for Gilead’s Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection in Adults to European stocks edge higher ahead of inflation report


Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Harvoni ® , an investigational once-daily tablet combining the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg, for the treatment of chronic hepatitis C virus (HCV) infection in adults.
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Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Zydelig ® (idelalisib 150 mg film-coated tablets), a first-in-class treatment for patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL), the most common subtype of indolent non-Hodgkin lymphoma (iNHL). The CHMP opinion supports the use of Zydelig in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy or, as first-line treatment in CLL patients in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy and also as monotherapy for the treatment of adult patients with FL that is refractory to
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Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Commission has approved Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor ( in vitro ), for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults.
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Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced that the European Commission has approved Eliquis for the treatment of DVT and PE, and the prevention of recurrent DVT and PE in adults.
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Rockwood Holdings, Inc. (NYSE:ROC) today announced that the European Commission has approved the previously announced sale of its Titanium Dioxide Pigments and four other non-strategic businesses to Huntsman Corporation (NYSE:HUN), a global specialty chemical company, for an enterprise value of $1.275 billion, including the assumption of $225 million in pension obligations.
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http://media.marketwire.com/attachments/200906/438886_oracleresized.jpg http://at.marketwire.com/accesstracking/AccessTrackingLogServlet?PrId=1141154&ProfileId=051205&sourceType=1 REDWOOD SHORES, CA --
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First biosimilar insulin to receive regulatory approval in the EU INDIANAPOLIS and RIDGEFIELD, Conn., Sept.
Sign-up for European Commission grants Lilly and Boehringer Ingelheim's insulin glargine product marketing authorisation in Europe investment picks
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the European Commission has granted marketing authorization for Zydelig ® (idelalisib), 150 mg tablets, a first-in-class oral treatment for two incurable blood cancers - chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). For the treatment of CLL, Zydelig has been approved for use in combination with rituximab for patients who have received at least one prior therapy; or as first-line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
Sign-up for European Commission Grants Marketing Authorization for Gilead’s Zydelig® (Idelalisib) for the Treatment of Chronic Lymphocytic Leukemia and Follicular Lymphoma investment picks
Alexion Pharmaceuticals (NASDAQ:ALXN) today announced that the European Commission has granted orphan drug designation (ODD) to Soliris® (eculizumab) for the treatment of patients with Myasthenia Gravis (MG), a rare, debilitating neurologic disorder caused by uncontrolled complement activation.
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2014/9/16
Technology has made it easier than ever for companies to manage the complex web of trading partners around the globe on whom their business increasingly depends.
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2014/8/12
By Tommy Stubbington Henkel falls as it warns of Ukraine impact -Tommy Stubbington ; 415-439-6400; AskNewswires@dowjones.com European stock markets drifted lower Tuesday as the previous session's strong rally fizzled out.
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Pfizer Inc. (NYSE:PFE) announced today that the European Medicines Agency (EMA) has accepted Pfizer’s application seeking to expand the indication for Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in adults to include the prevention of pneumonia caused by the 13 pneumococcal serotypes contained in the vaccine.
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Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the Marketing Authorization Application (MAA) for asfotase alfa, an investigational, first-in-class targeted enzyme replacement therapy for the treatment of hypophosphatasia (HPP), has been validated and granted accelerated assessment by the European Medicines Agency (EMA). The acceptance of this MAA marks the beginning of the review process in the European Union (EU) for this potential new treatment.
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Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for nivolumab in non-small cell lung cancer (NSCLC) – the first completed regulatory submission for a PD-1 immune checkpoint inhibitor in this tumor type.
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2014/9/22
By Carla Mozee, MarketWatch LONDON (MarketWatch) -- Mining stocks led losses in Europe on Monday on concerns that China, a major natural-resources buyer, will tolerate slower economic growth, but Merck KGaA outperformed following the German company's agreement to buy life-science company Sigma-Aldrich, a U.S. company.
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2014/8/7
By Carla Mozee, MarketWatch Commerzbank shares higher as profit doubles -Carla Mozee; 415-439-6400; AskNewswires@dowjones.com LONDON (MarketWatch) -- Nestlé SA and Adidas AG were among the companies whose shares made notable moves in European trade Thursday.
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2014/10/9
U.K. and Continental Natural Gas Prices Also Rose Month over Month LONDON , Oct.
Sign-up for European Power Prices up 35% as Bear Run Broke in September investment picks
2014/9/17
By Josie Cox European shares bounced back Wednesday, buoyed by a rise in U.S. stocks on Tuesday ahead of the release of latest Federal Reserve minutes and by targeted economic stimulus measures in China supporting Asian markets.
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2014/10/6
By Josie Cox European shares on Monday extended the gains they made after Friday's solid U.S. jobs report, despite downbeat industrial production figures out of Germany and fears that the European Union is preparing to reject France's 2015 budget.
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2014/9/15
By Josie Cox European shares edged lower Monday, burdened by Chinese industrial production growth slowing to a level last seen during the thick of the global financial crisis nearly six years ago.
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2014/9/15
By Josie Cox and Tommy Stubbington European shares edged lower Monday, burdened by Chinese industrial production growth slowing to a level last seen during the thick of the global financial crisis nearly six years ago.
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2014/9/15
By Josie Cox European shares slumped Monday, burdened by Chinese industrial production growth slowing to a level last seen during the thick of the global financial crisis almost six years ago.
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2014/7/14
By Sara Sjolin, MarketWatch LONDON (MarketWatch) -- European stock markets rose for a second straight day on Monday as fears about the soundness of Portuguese banks continued to recede and investors instead looked ahead to upcoming data and corporate results.
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2014/9/29
By Peter Nurse Equity markets closed lower in Europe on Monday, with investors nervous given the unrest in Hong Kong and ahead of the latest meeting of the European Central Bank.
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2014/9/4
By Carla Mozee, MarketWatch LONDON (MarketWatch) -- European stocks slipped Thursday as investors waited to find out whether the European Central Bank will pump more liquidity into the flagging euro-zone economy.
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2014/9/30
By Tommy Stubbington European stocks edged higher Tuesday, reversing part of the previous day's decline, as investors awaited eurozone inflation data that could be crucial to the European Central Bank's next move.
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2014/9/30
By Carla Mozee, MarketWatch LONDON (MarketWatch) -- Stocks in Europe held to thin gains Tuesday ahead of a key report on inflation in the eurozone.
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Articles From: European CHMP Adopts Positive Opinion for Gilead’s Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection in Adults to European stocks edge higher ahead of inflation report
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