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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).
Drug Research > Drug Delivery > News
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).
Drug Research > Drug Delivery > News 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.
Drug Research > Drug Delivery > News
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.
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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.
Drug Research > Drug Delivery > News
FDA grants orphan drug status to Eagle's bendamustine HCl to treat CLL and NHL
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted orphan drug designation to Eagle Pharmaceuticals' bendamustine hydrochloride (HCl) for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin’s lymphoma (NHL).
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Eisai gets EC approval of indication expansion for Halaven to treat breast cancer
By PBR Staff Writer
Japanese pharmaceutical firm Eisai has received approval from the European Commission (EC) of the indication expansion of Halaven (eribulin mesylate) to contribute to earlier treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease.
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Japan clears Anoro Ellipta (umeclidinium/vilanterol) for COPD treatment
GlaxoSmithKline plc and Theravance, Inc. announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Anoro Ellipta (umeclidinium/vilanterol) for the relief of various symptoms due to airway obstruction with chronic obstructive pulmonary diseases (chronic bronchitis, pulmonary emphysema) (in the case where concurrent use of long-acting inhaled muscarinic antagonist and long-acting inhaled beta2 agonist is required).
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