AstraZeneca Receives FDA Complete Response Letter for AXANUM New Drug Application
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- Category: AstraZeneca
AstraZeneca has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the new drug application for AXANUM (aspirin/esomeprazole magnesium) tablets.
Sanofi-aventis and Generics Leader Nichi-Iko to Establish New Joint Venture for Generics in Japan
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- Category: Sanofi
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Nichi-Iko Pharmaceutical Co., Ltd. (Nichi-Iko) (Osaka Stock Exchange and Nagoya Stock Exchange: NIK) have signed an agreement to establish a new joint venture, called sanofi-aventis Nichi-Iko K.K., in order to develop a generic business in Japan.
Novartis announces extension of US regulatory priority review period for FTY720
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- Category: Novartis
Novartis announced that the US Food and Drug Administration (FDA) has extended by three months, to September 2010, its review period for the regulatory approval of FTY720 (fingolimod).
Results of the clinical study CALYPSO Published in The Journal of Clinical Oncology
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- Category: Merck
Results of the clinical study CALYPSO, published online by The Journal of Clinical Oncology, show that patients in this study with platinum-sensitive relapsed ovarian cancer experienced longer progression-free survival than patients taking the current standard of care.
Genzyme Receives FDA Approval for Lumizyme for Pompe Disease
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- Category: Genzyme
Genzyme Corporation (Nasdaq: GENZ) announced that the FDA has granted U.S. marketing approval for Lumizyme™ (alglucosidase alfa), produced at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium.
European Medicines Agency maintains position on the continued use of Rotarix
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- Category: GlaxoSmithKline
GlaxoSmithKline (GSK) confirmed that following a meeting of the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency (EMA) has maintained its position that there is no evidence that the presence of porcine circovirus (PCV) in Rotarix™ presents a risk to public health and that there is no need to restrict its use in the European Union.
Ranibizumab significantly more effective than standard of care in treating vision loss due to DME
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- Category: Novartis
First results of the RESTORE Phase III study show that ranibizumab is significantly more effective than laser treatment, the current standard of care, at treating visual impairment due to diabetic macular edema (DME), a serious complication of diabetes[1].
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