Novartis demonstrates capabilities of cell-based technology for production of A(H1N1) vaccine
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- Category: Novartis
Novartis has successfully completed the production of the first batch of influenza A(H1N1) vaccine, weeks ahead of expectations. Cell-based manufacturing technology[1] allows vaccine production to be initiated once a pandemic virus strain is identified without the need to adapt the virus strain to grow in eggs, as with traditional vaccine technologies. This advance has cut weeks off the time required to begin vaccine production.
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.
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