Genzyme Receives European Approval of Renvela for Patients with Chronic Kidney Disease
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- Category: Genzyme
Genzyme Corporation (Nasdaq: GENZ) announced that the European Commission has approved Renvela® (sevelamer carbonate) for the control of serum phosphorus in patients with chronic kidney disease (CKD). The approval includes patients not on dialysis with serum phosphorus levels ≥ 1.78 mmol/L (5.5 mg/dL), and covers both the tablet and powder formulations.
Abbott Announces Launch of Next-Generation Embolic Protection System
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- Category: Abbott
Abbott (NYSE: ABT) has announced the launch of the sixth-generation Emboshield NAV6(TM) Embolic Protection System for use in carotid artery stenting procedures. Carotid artery stenting provides a minimally invasive treatment alternative to conventional open carotid artery surgery for patients who are at high risk for surgery.
Favourable Vote from FDA Advisory Committee on Seroquel Paediatric Applications
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- Category: AstraZeneca
The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee conducted a review of the efficacy and safety of supplemental new drug applications (sNDAs) for SEROQUEL (quetiapine fumarate) proposed for the acute treatment of schizophrenia in adolescents (13-17 years of age), and the acute treatment of bipolar mania in children and adolescents (10-17 years of age).
Takeda to Revise Timing of Alogliptin and Alogliptin/ACTOS MAA Filing in Europe
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- Category: Takeda
Takeda Pharmaceutical Company Limited ("Takeda") has reviewed the development strategy for the Marketing Authorization Applications (MAAs) for its investigational compounds, alogliptin and alogliptin/ACTOS (generic name: pioglitazone HCl), in Europe, and accordingly, has initiated an additional long-term clinical study for alogliptin.
GSK and Shenzhen Neptunus create new alliance to develop and manufacture influenza vaccines in China
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- Category: GlaxoSmithKline
GlaxoSmithKline plc (GSK) has entered into a definitive agreement to form a new Joint Venture with Shenzhen Neptunus Interlong Bio-Technique Co. Ltd (Shenzhen Neptunus) focused on developing and manufacturing influenza vaccines for the Chinese market.
Sanofi-aventis to strengthen Insulin Production Capacities
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- Category: Sanofi
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced that Sanofi-Aventis Deutschland GmbH has purchased from Pfizer the Diabel manufacturing plant in Frankfurt-Höchst, Germany, one of the largest state-of-the-art insulin manufacturing plants in the world.
Novartis announces typhoid vaccine research program in partnership with the Wellcome Trust
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- Category: Novartis
Novartis announced that the Novartis Vaccines Institute for Global Health (NVGH) has been awarded a grant from the Wellcome Trust to develop a bivalent vaccine for Typhoid fever, a disease that affects more than 21 million people worldwide every year.
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