Articles Referencing MAA

Zacks.com

Gilead's Sofosbuvir under European Review - Analyst Blog

Gilead Sciences Inc. ( GILD ) recently announced that its Marketing Authorisation Application (MAA) for HCV candidate sofosbuvir (formerly GS-7977), submitted to the European Medicines... Read >>

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Bayer's Xofigo Cleared in the US - Analyst Blog

Bayer 's ( BAYRY ) HealthCare segment recently received encouraging news as the US Food and Drug Administration (FDA) approved its oncology drug Xofigo (radium 223 dichloride). Xofigo was... Read >>

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ARNA Sheds Light on Belviq Launch - Analyst Blog

Arena Pharmaceuticals Inc. ( ARNA ) recently announced that the US Drug Enforcement Administration (DEA) has assigned its obesity drug Belviq into Schedule IV of the Controlled Substances... Read >>

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Ariad Posts Wider Y/Y Loss - Analyst Blog

Ariad Pharmaceuticals, Inc. ( ARIA ) reported first quarter loss of 36 cents per share, wider than the year-ago loss of 25 cents per share but narrower than the Zacks Consensus Estimate of... Read >>

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Wider-than-Expected Loss at Endocyte - Analyst Blog

Endocyte, Inc. ( ECYT ) reported first quarter 2013 net loss per share of 11 cents, wider than the Zacks Consensus Estimate of a loss of 5 cents but narrower thanĀ  the year-ago loss... Read >>

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Arena Pharma Narrows Loss - Analyst Blog

Arena Pharmaceuticals Inc. 's ( ARNA ) loss (excluding special items) of 10 cents per share in the first quarter of 2013 was narrower than the year-ago loss of 15 cents per share. The Zacks... Read >>

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Loss at Aegerion Narrower Than Expected - Analyst Blog

Aegerion Pharmaceuticals, Inc. ( AEGR ) reported first quarter 2013 net loss per share of 64 cents, narrower than the Zacks Consensus Estimate of a loss of 72 cents, but wider than... Read >>

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Positive CHMP Opinion for Avanir - Analyst Blog

Avanir Pharmaceuticals, Inc. ( AVNR ) recently received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for Nuedexta. Nuedexta is under review in the EU... Read >>

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BioMarin Widens Loss, Maintains View - Analyst Blog

BioMarin Pharmaceutical Inc. 's ( BMRN ) first quarter 2013 loss of 31 cents per share was wider than the Zacks Consensus Estimate of a loss of 28 cents per share and the year-ago loss... Read >>

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SNY's Vaxigrip Filing Accepted in EU - Analyst Blog

Sanofi ( SNY ) recently announced that a decentralized marketing authorization application (MAA) for its quadrivalent flu vaccine, Vaxigrip, has been accepted for review in the EU. The... Read >>

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ARNA/Eisai's Belviq Filed in Mexico - Analyst Blog

Arena Pharmaceuticals, Inc. ( ARNA ) recently announced that Eisai Laboratories S. de R.L. de C.V, a subsidiary of Eisai Inc., has submitted a marketing authorization application (MAA) for... Read >>

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Vivus Opts for Royalty Financing - Analyst Blog

Vivus, Inc. ( VVUS ) recently announced that it has entered into an agreement with a Pharmakon Advisors managed investment fund for a $110 million non-equity financing. Vivus will initially... Read >>

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Lilly Progresses with Empagliflozin - Analyst Blog

Eli Lilly ( LLY ) and Boehringer Ingelheim recently submitted a New Drug Application (NDA) for their type II diabetes candidate, empagliflozin, in the US. Earlier this year, Eli Lilly... Read >>

Zacks.com

Astellas' Acofide Approved in Japan - Analyst Blog

Astellas Pharma, Inc. ( ALPMY ) and Zeria Pharmaceutical Co., Ltd. recently announced that it received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for Acofide for... Read >>

Zacks.com

Gilead's Stribild Backed by CHMP - Analyst Blog

Gilead Sciences, Inc. ( GILD ) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recently rendered a positive opinion on its HIV... Read >>

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