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].
Abbott to Become No. 1 Pharmaceutical Company in India
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- Category: Abbott
Abbott (NYSE: ABT) announced a definitive agreement with Piramal Healthcare Limited to acquire full ownership of Piramal's Healthcare Solutions business (Domestic Formulations), a leader in the Indian branded generics market, for an up-front payment of $2.12 billion, plus $400 million annually for the next four years, giving Abbott the No. 1 position in the Indian pharmaceutical market.
Pfizer Global Manufacturing Announces Plans to Reconfigure its Global Plant Network
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- Category: Pfizer
Pfizer Global Manufacturing announced plans to reconfigure its worldwide plant network to create a fully aligned manufacturing and supply organization from the combined networks of Pfizer and Wyeth.
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- Bayer receives approval for its new oral contraceptive in the U.S.