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Vifor Pharma's hyperphosphatemia drug Velphoro gets FDA approvalThe US Food and Drug Administration (FDA) has approved Vifor Pharma's hyperphosphatemia drug Velphoro for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialys2013/12/3
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Novartis Foundation Launches New Leprosy Strategy at Symposium on Disease EliminationToday's symposium of the Novartis Foundation for Sustainable Development (NFSD) convenes experts to discuss "What does it take to eliminate a disease?" Drawing lessons from previous successful disease2013/12/2
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Rx-360 Applauds Passage of Drug Quality and Security ActRx-360 applauds the passage of the bipartisan Drug Quality and Security Act, H.R. 3204. The Act was approved by the House of Representatives in September and by the Senate on 18 November. President Ob2013/12/2
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FDA Warning Letter Statistics 2013 Regarding Process Validation/Qualification/CalibrationIn 2013, process validation was at the top of the critised deviations. Missing or insufficient process validation was quoted 15 times. The most frequent critics were made to dosage forms (five times)2013/11/29
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New Cholesterol Treatment Guidelines ‘Hard to Swallow’ for Non-Statin Manufacturers in Cardiovascular Drug MarketUpdated guidelines for the treatment of hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD) could well give the statin market a substantial boost over the coming years, but they wi2013/11/29
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Thermo Fisher Scientific Receives Clearance from the European Commission for its Acquisition of Life TechnologiesThermo Fisher Scientific, the world leader in serving science, today announced that it has received approval from the European Commission for its pending acquisition of Life Technologies Corporation.2013/11/28
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FDA Approves Merck’s NOXAFIL (posaconazole) Delayed-Release TabletsMerck, known as MSD outside the US and Canada,has announced that FDA has approved NOXAFIL(posaconazole) 100 mg delayed-release tablets. NOXAFIL delayed-release tablets are a new formulation with a loa2013/11/28
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Agalimmune Ltd Founded to Develop Immunotherapeutics for CancerAgalimmune Ltd, a biopharmaceutical company, has been created to develop innovative immunotherapeutics for the treatment of cancer, with a focus on solid tumours. The new company has been founded by a2013/11/27
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Janssen obtains FDA approval for Olysio combination therapy for hepatitis C treatmentJanssen Therapeutics has received approval from the US Food and Drug Administration (FDA) for an NS3/4A protease inhibitor, Olysio (simeprevir), to treat chronic hepatitis C infection as part of an an2013/11/27
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ViiV Healthcare obtains European positive opinion for HIV drug TivicayEuropean Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the marketing authorisation of ViiV Healthcare's Tivicay (dolutegravir) in com2013/11/26