News

FDA has changed the label for fenofibric acid (Trilipix, Abbott). It now carries a warning that the agent may not lower the risk of myocardial infarction or stroke.

All children and adolescents should be screened for high cholesterol, and children as young as aged 10 should be considered for treatment with statins, according to the latest update from an expert panel convened by the National Heart, Lung, and Blood Institute.

The American Heart Association and American College of Cardiology Foundation have issued new guidelines for secondary prevention and risk reduction in patients with atherosclerotic vascular disease.

Some essential chemotherapy drugs are in short supply for the first time in the United States, according to the October 3 New England Journal of Medicine.

FDA is requiring that manufacturers of tumor necrosis factor blockers perform enhanced safety surveillance, the agency said on November 3 in an ongoing safety review of this class of biologic products.

FDA has approved aflibercept (Eylea Injection, Regeneron), known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) age-related macular degeneration in patients aged 60 and older at a recommended dose of 2 mg every 4 weeks (monthly) for the first 12 weeks, followed by 2 mg every 8 weeks (2 months).

FDA approved ruxolitinib (Jakafi, Incyte) for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.

FDA Commissioner Margaret A. Hamburg, MD, announced the agency's decision to revoke the breast cancer indication for bevacizumab (Avastin), noting that the benefits do not outweigh the potentially life-threatening side effects, such as heart attack or heart failure, high blood pressure, bleeding and hemorrhaging, and the development of perforations in different parts of the body, such as the nose, stomach, and intestines.

Davis leaves a legacy of health policy research and practical improvments

Two University of Michigan (UM) developed healthcare initiatives were recommended to the U.S. Secretary of Health and Human Services in an Institute of Medicine report about the future of the nation’s healthcare.

Medicare Advantage plans may have a difficult time attaining four- and five-star ratings under the Centers for Medicare & Medicaid Services’ (CMS) Five-Star Quality Rating System if they don’t keep up with the system’s changes.

Epilepsy and Parkinson’s disease

New formulation: Tapentadol extended release tablets were FDA approved for the management of moderate-to-severe chronic persistence pain requiring continuous maintenance in adults.

This study aims to illuminate anticoagulation prophylaxis practice patterns in the United States after total joint replacement surgery.

Safety information chagnes to the package insert for bevacizumab were issued by FDA on September 30, 2011.

The outcry from physicians, pharmacists, and patients over disruptions in supplies of vital medicines to treat cancer, pain, and other serious conditions is drawing attention from the White House, Congress and the broader healthcare system.

Switching hospitalized patients able to take medication by mouth from intravenous to pill forms of the same drugs could safely save millions of dollars a year.

Pharmacogenomics can change the way patients are treated.

Patients with hepatitis C virus (HCV) who were more adherence to their pegylated interferon and ribavirin treatment were more likely to achieve both an early and sustained virologic response.

When an anthracycline is not used concomitantly with adjuvant trastuzumab to treat HER2-positive breast cancer, cardiac toxicity is reduced.

Specialty pharmaceutical research and development spending is expected to increase with the focus on "biobetters", biosimilars, and novel therapies.

The rheumatoid arthritis payer market has experienced increasingly competitive forces, prompting RA drug manufacturers to experiment with new contracting initiatives to gain preferred formulary placement.

Recent FDA Approvals (through October 2011) related to Xarelto, Combivent Respimat Inhalation Spray, Exparel, Byetta, Onfi, Euflexxa, Cialis, Clindamycin injection, Ferriprox

New molecular entity: Ezogabine was FDA approved for use as an add-on medication to treat partial-onset seizures associated with epilepsy in adults.

Edith Rosato, RPh, has recently been appointed new CEO of the Academy of Managed Care Pharmacy.

Recent FDA action (through October 2011) related to golimumab expanded label, meningococcal and Hib combination vaccine, desvenlafaxine, rivaroxaban anticoagulant, deferiprone oral iron chelator, glucarpidase experimental treatment, doxidopa, QLT091001, NP-001,cyclophosphamide, resminostat oral pan HDAC inhibitor, TXA127

Crizotinib is a new kinase inhibitor recently approved by FDA for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer who express the anaplastic lymphoma kinase gene.

Among the long-awaited provisions in PPACA are the additions to the Public Health Service Act that allow for the introduction of biosimilar medications to the marketplace.