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From the Blogosphere
Sanofi’s Multaq Gains EU Approval – Analyst Blog
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Sanofi-Aventis (SNY) received good news recently with the company gaining approval from the European Commission for its atrial fibrillation drug, Multaq. The product gained approval for use in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.
The approval does not come as a surprise as Multaq recently received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). The CHMP recommended that Multaq should receiv...
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AstraZeneca Seeks FDA Approval – Analyst Blog
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Recently, AstraZeneca plc (AZN) announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its blood clot preventer Brilinta (ticagrelor). Brilinta is an oral reversible P2Y12 adenosine diphosphate receptor antagonist for arterial thrombosis aimed to compete with the blockbuster drug Plavix which is co-developed by Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY). On Oct 26, 2009, AstraZeneca filed for approval of the drug with the European Medicines Agency (EMEA) and is awaiting validation of the application.
AstraZeneca is seeking an FD...
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MDVN Starts New Alzheimer’s Trials – Analyst Blog
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Earlier this month, Medivation, Inc. (MDVN) and Pfizer, Inc. (PFE) initiated two phase III studies, CONTACT and CONSTELLATION, with Dimebon in patients with moderate-to-severe Alzheimer's disease (AD). Dimebon is being developed in collaboration with Pfizer for the treatment of Alzheimer’s and Huntington diseases.
The CONTACT study will assess the potential benefits of adding Dimebon to ongoing treatment with Pfizer’s Aricept on neuropsychiatric symptoms and activities of daily living. Meanwhile, the CONSTELLATION study will evaluate the effects of adding Dimebon to Forest Lab’s (FRX) ...
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Another Win for Mylan – Analyst Blog
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Recently, Mylan Inc.‘s (MYL) subsidiary, Matrix Laboratories received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-release (DR) capsules in two dosage forms (15 mg and 30 mg). Mylan plans to begin shipment of the product immediately.
The drug is the generic version of Takeda Pharmaceuticals' (TKPHY.PK) proton pump inhibitor Prevacid DR Capsules. According to IMS Health (RX), the branded version had US sales of approximately $3 billion for the 12 months ending June 30.
Mylan received quite a few app...
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AstraZeneca Beats, Raises – Analyst Blog
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AstraZeneca’s (AZN) third quarter earnings came in at $1.68 per American Depositary Shares (ADS), well above the Zacks Consensus Estimate of $1.36 and $1.32 reported in the year-ago period. Revenues increased 10% at constant exchange rates (CER) to $8.2 billion compared to the same period last year.
The primary reasons for the increase in revenues were strong US sales of Toprol-XL benefiting from generic withdrawal, US sales of its H1N1 vaccine and robust growth in emerging markets.
AstraZeneca recorded strong sales across all geographies. Sales in North America, Emerging Markets and Estab...
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About N 2009 Apr 18 5.00 Call
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