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GlaxoSmithKline files regulatory application in Europe for malaria vaccine By PBR Staff Writer
British drug-maker GlaxoSmithKline (GSK) has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S.
Drug Research > Drug Delivery > News
FDA approves Eagle's malignant hyperthermia treatment Ryanodex By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Eagle Pharmaceuticals' Ryanodex (dantrolene sodium) for injectable suspension to treat malignant hyperthermia (MH), along with the appropriate supportive measures.
Drug Research > Drug Delivery > News Biogen Idec's multiple sclerosis drug Plegridy gets European approval By PBR Staff Writer
US-based biotechnology firm Biogen Idec (BIIB) has received marketing authorization from the European Commission (EC) for Plegridy (peginterferon beta-1a) to treat adults with relapsing-remitting multiple sclerosis (RRMS).
Drug Research > Drug Delivery > News
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Regeneron, Bayer release positive Phase III trial results of EYLEA to treat DME
By PBR Staff Writer
Regeneron Pharmaceuticals and Bayer HealthCare have released positive results from the Phase III VIVID-DME trial of EYLEA (aflibercept) Injection indicated to treat diabetic macular edema (DME).
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Durata Therapeutics launches DALVANCE for injection in US
By PBR Staff Writer
Durata Therapeutics has launched DALVANCE (dalbavancin) for injection in the US to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI).
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Amgen reports positive Phase III results for AMG 416 to treat secondary hyperparathyroidism in CKD patients
Amgen has announced that a Phase III study evaluating AMG 416 (formerly known as velcalcetide) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis, met its primary and all secondary endpoints.
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Octapharma gets FDA approval for immune thrombocytopenic purpura therapy Octagam 10%
By PBR Staff Writer
Octapharma USA has received approval from the US Food and Drug Administration (FDA) for its Octagam 10% to treat adults with chronic immune thrombocytopenic purpura (ITP), a platelet disorder that can result in easy or excessive bruising and bleeding.
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Basilea seeks European approval for isavuconazole to treat invasive mold infections
Basilea Pharmaceutica reports that it submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis (zygomycosis).
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FDA approves Salix’s RELISTOR subcutaneous injection sNDA
Salix Pharmaceuticals and Progenics Pharmaceuticals have announced that the Food and Drug Administration (FDA or Agency) has informed Salix that RELISTOR (methylnaltrexone bromide) Subcutaneous Injection, 20 mg/ml, for the treatment of opioid-induced constipation (OIC) in patients taking opioids for chronic non-cancer pain can be approved on the data submitted in the sNDA.
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Hemispherx Biopharma, Bioclones join forces on novel therapeutic cancer vaccine
Hemispherx Biopharma announced a strategic alliance to develop multiple projects with Bioclones, a leading South African biotechnology company.
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Medac gets FDA approval for Rasuvo injection to treat rheumatoid arthritis, pJIA and psoriasis
By PBR Staff Writer
US-based Medac Pharma has received approval from the US Food and Drug Administration (FDA) for Rasuvo, a subcutaneous injectable methotrexate (MTX) therapy delivered in an auto-injector for rheumatoid arthritis (RA), polyarticular-course juvenile idiopathic arthritis (pJIA) and psoriasis.
Drug Research > Drug Delivery > News
Kaleo makes opioid overdose drug EVZIO available in US
By PBR Staff Writer
Kaleo has announced the US commercial availability of EVZIO for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Drug Research > Drug Delivery > News
OPKO's factor VIIa-CTP gets positive opinion for three orphan drug designations in Europe
OPKO Health (OPK) has announced that the European Committee for Orphan Medicinal Products (COMP) has granted a positive opinion recommending the approval of orphan drug designation for OPKO's long-acting version of clotting Factor VIIa (Factor VIIa-CTP) for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to Factor VIII or Factor IX and congenital Factor VII deficiency.
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