FDA approves carfilzomib for some patients with multiple myeloma
July 20th 2012FDA has approved carfilzomib (Kyprolis, Onyx Pharmaceuticals) to treat patients with multiple myeloma who have received at least 2 prior therapies, including treatment with bortezomib (Velcade, Takeda) and an immunomodulatory therapy.
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FDA approves once-daily phentermine and topiramate extended-release for weight management
July 20th 2012FDA has approved once-daily phentermine and topiramate extended-release (Qsymia, Vivus) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 or greater, or 27 or greater in the presence of at least 1 weight-related comorbidity.
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FDA: Label change for single IV dose of ondansetron
July 20th 2012FDA is alerting healthcare professionals to the possibility that a 32-mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) could lead to QT interval prolongation, putting patients at risk for a potentially fatal heart rhythm known as Torsades de Pointes.
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FDA approves once-daily oral agent for HIV prevention in uninfected adults
July 17th 2012FDA has approved once-daily oral emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead Sciences), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.
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FDA approves generic Arthrotec
July 16th 2012FDA has approved Watson's generic diclofenac sodium and misoprostol delayed-release tablets (Arthrotec, G.D. Searle, a subsidiary of Pfizer), indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.
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Cost transparency becomes critical
July 16th 2012The Patient Protection and Affordable Care Act’s provisions for states to implement health insurance exchanges, combined with employers shifting more responsibility for healthcare costs to employees, is expected to create a greater demand for healthcare cost transparency.
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Fixed-dose ARB combo superior treatment for hypertension
July 13th 2012A fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg (Edarbyclor, Takeda Pharmaceuticals) was statistically superior to a fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg for the treatment of stage 2 systolic hypertension, according to a study published online in the American Heart Association journal Hypertension.
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Global drug spend projected to reach more than $1 trillion by 2016
July 13th 2012Annual global spending on medicines will reach nearly $1.2 trillion by 2016, while U.S. spending growth is projected to soar to between $350 and $380 billion by 2016, according to a report issued recently by the IMS Institute for Healthcare Informatics.
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