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FDA extend review timeline for vandetanib new drug application
AstraZeneca announced that the US Food and Drug Administration (FDA) has extended the time to complete its review of the New Drug Application (NDA) for the investigational drug vandetanib. ย As part of the...
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Daxas (Roflumilast) included as a new treatment option in latest international COPD guidelines
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) has included roflumilast (Daxasยฎ) as a new treatment option in its COPD management guidelines. A section on the new class, phosphodiesterase 4 (PDE4) inhibitors, describes the efficacy of roflumilast in...
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Merck to Hold Fourth-Quarter 2010 Sales and Earnings Conference Call on Feb. 3
Merck will hold its fourth-quarter 2010 sales and earnings conference call with institutional investors and analysts beginning at 8 a.m. EST on Thursday, Feb. 3. During the call, Kenneth C. Frazier, chief executive officer, Peter N. Kellogg, executive vice...
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Teva Completes Acquisition of Theramex
Teva Pharmaceutical Industries Ltd. announced that it has completed the acquisition of Theramex, Merck KGaA's European-based women's health business.ย Acquisition Provides Teva with a Strong Platform to Expand its Global Women's Health Franchise Theramex brings...
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Novartis drug Tasigna received approval from the European Commission
Novartis received approval from the European Commission for Tasignaยฎ (nilotinib) as a treatment for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The approval from the European Commission...
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Arena and Eisai Complete End-of-Review Meeting with FDA
Arena Pharmaceuticals, Inc. and Eisai Inc. announced today the completion of an end-of-review meeting with the US Food and Drug Administration (FDA) for the lorcaserin New Drug Application (NDA). Jack Lief, Arena's President and Chief Executive...
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Lundbeck enters into drug discovery collaboration with Zenobia and Vernalis
H. Lundbeck A/S announced that it has signed agreements with Zenobia Therapeutics (Zenobia) and Vernalis plc (Vernalis) which will provide Lundbeck with access to know-how relevant for making inhibitors for Leucine-rich repeat kinases. Lundbeck will...
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