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Swedish Orphan Biovitrum AB (Sobi) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines...

Sobi (Swedish Orphan Biovitrium)) has filed an application for an EU Marketing Authorization with the European Medicines Agency (EMA) for...

Swedish Orphan Biovitrum AB announced that the European Commission (EC) has approved Kineret (anakinra) for the treatment of Cryopyrin-Associated Periodic...

Hyperkalemia is one of the main electrolyte disorders in patients with chronic kidney disease (CKD). The prevalence of hyperkalemia increases as the Glomerular Filtration Rate (GFR) declines.

Mallinckrodt Plc announced positive top-line results from its pivotal Phase III CONFIRM clinical study evaluating the efficacy and safety of...

Mallinckrodt Plc, announced findings from two retrospective medical chart review studies on real world outcomes of patients hospitalized with hepatorenal syndrome type-1 (HRS-1) treated with terlipressin and other vasopressors

For use as a spermicidal contraceptive in conjunction with barrier methods of contraception such as diaphragms or caps.

Rheumatoid Arthritis (RA) Kineret is indicated in adults for the treatment of the signs and symptoms of RA in combination with methotrexate, with an inadequate response to methotrexate alone. Periodic fever syndromes Kineret is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above: Cryopyrin-Associated Periodic Syndromes (CAPS) Kineret is indicated for the treatment of CAPS, including: - Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA) - Muckle-Wells Syndrome (MWS) - Familial Cold Autoinflammatory Syndrome (FCAS) Familial Mediterranean Fever (FMF) Kineret is indicated for the treatment of Familial Mediterranean Fever (FMF). Kineret should be given in combination with colchicine, if appropriate. Still's Disease Kineret is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Still's disease, including Systemic Juvenile Idiopathic Arthritis (SJIA) and Adult-Onset Still's Disease (AOSD), with active systemic features of moderate to high disease activity, or in patients with continued disease activity after treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids. Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).

Sobi, an international biopharmaceutical company dedicated to rare diseases, announced that the FDA has approved the supplemental Biologics License Application (sBLA) for Kineret(anakinra) for the treatment of deficiency of IL-1 receptor antagonist (DIRA). Kineret was originally approved by FDA in November 2001 for moderate to severe active rheumatoid arthritis and in January 2013 for a severe form of Cryopyrin-Associated Periodic Syndromes (CAPS), known as NOMID.

H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) have submitted a supplemental New Drug Application (sNDA) for FDA review of brexpiprazole as combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD) in adults