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Vascepa (Icosapent ethyl)

New molecular entity: FDA approved icosapent ethyl (Vascepa, Amarin Pharmaceuticals Ireland Limited), an ethyl ester of eicosapentaenoic acid (EPA), as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia.

FDA has approved omacetaxine mepesuccinate (Synribo, Teva) to treat adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease. An estimated 5,430 people will be diagnosed with CML in 2012, according to the National Institutes of Health. Synribo is intended to be used in patients whose cancer progressed after treatment with at least 2 drugs from a class called tyrosine kinase inhibitors (TKIs), also used to treat CML.

Long-term treatment of folic acid and vitamin B6 and vitamin12 had no statistically significant effect on colorectal adenoma among women who were at high risk for cardiovascular disease, according to recent study published in the Journal of the National Cancer Institute.

Half of the 3.2 billion prescriptions dispensed annually are not taken as prescribed. Pharmacy benefit leaders must reconsider the financial context of medication adherence and medication possession, according to industry leaders presenting at an online seminar for the Pharmacy Benefit Management Institute in October.

The Advisory Committee for Immunization Practices (ACIP) voted to recommend the use of Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine (MenHibrix, GlaxoSmithKline) in infants at increased risk for bacterial meningitis.

Numerous health and safety violations related to the practice of pharmacy at the New England Compounding Center (NECC), Framingham, Mass. have been documented by investigators of the Massachusetts Department of Public Health (DPH), according to Madeleine Biondolillo, MD, in a press conference Oct. 23

Three investigational drugs will be studied in a worldwide clinical trial to determine whether they can prevent Alzheimer’s disease. In people with inherited mutations that cause early-onset Alzheimer’s, the study will seek to identify whether the drugs can improve Alzheimer’s disease biomarkers and prevent the loss of cognitive function.

FDA and the Centers for Disease Control and Prevention (CDC) confirm that the fungus Exserohilum rostratum contaminated 1 of the 3 implicated lots of preservative-free methylprednisolone acetate (80 mg/mL) from the New England Compounding Center (NECC), which the company recalled September 26.

FDA has expanded the approved indication for tocilizumab (Actemra, Genentech) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to 1 or more disease-modifying antirheumatic drugs (DMARDs).

Patients who experience a warfarin-associated gastrointestinal tract bleeding event should resume anticoagulation therapy during the 90 days following the event to decrease the risk of thrombosis and death, according to a study published online in the Archives of Internal Medicine.

FDA has approved paclitaxel protein-bound particles for injectable suspension) (albumin-bound) (Abraxane, Celgene) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.