US Food and Drug Administration extend review timeline for vandetanib
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- Category: AstraZeneca
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.
KOMBIGLYZE™ XR Now Available in U.S. Pharmacies
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- Category: Bristol-Myers Squibb
Bristol-Myers Squibb Company (NYSE: BMY), and AstraZeneca (NYSE: AZN) announced that KOMBIGLYZE™ XR (saxagliptin and metformin HCl extended-release), approved by the U.S. Food and Drug Administration (FDA) on November 5, 2010, is now available by prescription in pharmacies across the United States.
FDA grants supplemental approval for ACTEMRA
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the United States (U.S.) Food and Drug Administration (FDA) has extended the ACTEMRA (tocilizumab, RoACTEMRA in the European Union) label to include inhibition and slowing of structural joint damage, improvement of physical function,
Amgen and Xencor Enter Option Deal to Co-Develop Xencor's Novel Antibody for Autoimmune Diseases
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- Category: Amgen
Amgen (Nasdaq: AMGN) and Xencor, Inc. will collaborate to develop XmAb(R)5871, an Fc- engineered monoclonal antibody dually targeting CD19 and CD32b. XmAb5871 is currently in late-stage preclinical development for the treatment of autoimmune diseases.
Daxas® (Roflumilast) included as a new treatment option in latest international COPD guidelines
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- Category: Nycomed
The Global Initiative for Chronic Obstructive Lung Disease (GOLD) has included roflumilast (Daxas®) 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 patients with COPD.
Merck KGaA Acquires Supplier to Biopharma Industry in China
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- Category: Merck Group
Merck KGaA has acquired 100% of the share capital of Beijing Skywing Technology Co., Ltd., a leading supplier of cell-culture media products, related technical services and bioreactors for the Chinese biopharmaceutical industry. The company is headquartered in the Changping district of Beijing and currently employs 80 people.
GSK responds to 60 Minutes | Related Video
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- Category: GlaxoSmithKline
GlaxoSmithKline (GSK) issued the following response regarding a 60 Minutes program on January 2 that focused on a manufacturing facility in Puerto Rico which was formerly owned by the company.
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