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FDA has issued 3 draft guidances for the development of biosimilar versions of approved biologic products, which will help flesh out the abbreviated approval pathway created by the Patient Protection and Affordable Care Act signed into law in 2010.

An FDA advisory panel recommended against using denosumab (Xgeva, Amgen) to delay or prevent the spread of castration-resistant prostate cancer at risk for bone metastases. The FDA?s Oncologic Drugs Advisory Committee concluded that the drug offered a statistical benefit but not a clinical benefit.

U.S. drug expenditures remained relatively flat in 2011, but a new report projects that drug costs will rise between 3% and 5% across all healthcare settings this year. .

FDA approved sitagliptin and metformin hydrochloride (HCl) extended-release (Janumet XR, Merck) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of Januvia (sitagliptin), with extended-release metformin.

Nursing home residents with dementia who use average doses of selective serotonin reuptake inhibitors (SSRIs) are 3 times more likely to have a fall resulting in injury compared with those who don?t use SSRIs, according a study published online January 18 in the British Journal of Clinical Pharmacology.

Researchers are warning pediatricians, pediatric hospitalists, and intensivists of the potential for intravenous acetaminophen dosing errors, especially in young patients under 2 years old.