Articles Referencing CRL

Zacks.com

Good News for Novartis' Ilaris - Analyst Blog

Novartis ( NVS ) recently announced that the US Food and Drug Administration (FDA) has approved Ilaris (canakinumab) for an additional indication. Ilaris is now approved for the... Read >>

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Salix Beats on Earnings - Analyst Blog

Salix Pharmaceuticals, Ltd. ( SLXP ) posted first quarter earnings of 56 cents per share, above the Zacks Consensus Estimate of 55 cents and the year-ago earnings of 42 cents. Excluding... Read >>

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ABCO Posts Solid 4Q and FY2013 Earnings - Analyst Blog

The Advisory Board Company ( ABCO ) reported fourth quarter fiscal 2013 operating earnings of 33 cents per share surpassing the Zacks Consensus Estimate of 21 cents per share. Results also... Read >>

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Charles River Misses Estimates in 1Q - Analyst Blog

Charles River Laboratories ( CRL ) reported first quarter 2013 earnings (excluding special items) of 63 cents per share, missing the Zacks Consensus Estimate of 71 cents. Earnings were... Read >>

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Glaxo-Impax End Rytary Deal - Analyst Blog

GlaxoSmithKline ( GSK ) and Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. ( IPXL ), recently announced the termination of their agreement for Rytary... Read >>

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Data on Teva's Milprosa - Analyst Blog

Teva Pharmaceuticals ( TEVA ) recently announced new data from a phase III study on Milprosa (progesterone) vaginal ring which is being developed for luteal phase support in women... Read >>

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Priority Review for Bayer's Riociguat - Analyst Blog

Bayer 's ( BAYRY ) HealthCare segment recently received encouraging news from the US Food and Drug Administration (FDA) as it granted priority review designation to the New Drug Application... Read >>

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Data Presented on Bayer's ATX-101 - Analyst Blog

Bayer AG ( BAYRY ) recently presented positive results on ATX-101 at the 11th Anti-Aging Medicine World Congress (AMWC) 2013. ATX-101 is being developed for the reduction of unwanted fat... Read >>

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Glaxo's Flu Vaccine Approved - Analyst Blog

GlaxoSmithKline ( GSK ) recently announced the receipt of marketing authorization for its four-strain seasonal influenza vaccine in Germany and the UK. The vaccine will be marketed as... Read >>

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Glaxo's Influenza Vaccine Gets CRL - Analyst Blog

GlaxoSmithKline ( GSK ) recently received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the company's influenza vaccine candidate, Q-Pan H5N1... Read >>

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Japanese Approval for Bayer's drug - Analyst Blog

Bayer 's ( BAYRY ) HealthCare segment recently received encouraging news as the Ministry of Health, Labour and Welfare (MHLW) in Japan approved Stivarga (regorafenib). Stivarga is approved... Read >>

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Another CRL for UTHR's Oral Remodulin - Analyst Blog

The US Food and Drug Administration (FDA) recently issued a second complete response letter (CRL) for United Therapeutics Corporation's ( UTHR ) new drug application for oral Remodulin... Read >>

Zacks.com

CHMP Positive on Bayer's Xarelto - Analyst Blog

Bayer 's ( BAYRY ) HealthCare segment recently received a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) for Xarelto (rivaroxaban) in... Read >>

Zacks.com

Good News for Novartis Candidate - Analyst Blog

Novartis ( NVS ) recently announced that the US Food and Drug Administration (FDA) rendered Breakthrough Therapy designation to its pipeline candidate LDK378. The Breakthrough Therapy... Read >>

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Loss at OREX Narrower than Expected - Analyst Blog

Orexigen Therapeutics, Inc. ( OREX ) reported a net loss of 41 cents per share in the fourth quarter of 2012, much wider than the year-ago loss of 9 cents but 4 cents narrower than the... Read >>

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