News

The active drug safety surveillance system being established by FDA promises to do more than obtain timely adverse event information on marketed medicines.

New molecular entity: Vilazodone hydrochloride tablets were approved by FDA on January 21, 2011, for the treatment of major depressive disorder in adults.

Recent FDA Approvals (through February 2011) related to Edarbi, Gralise, Rituxan, Menveo, Makena, Corifact, Epicyn HydroGel

In recent years there has been an explosion of new investigations into the pathophysiology of bipolar disorder and its medication therapies. This article will review current, emerging, and controversial therapies for the treatment of bipolar disorder, specifically the mania aspect.

Ceftaroline has demonstrated activity against methicillin-resistant Staphylococcus aureus and multidrug-resistant Streptococcus pneumoniae as well as common respiratory Gram-negatives including Haemophilus, Moraxella, and Klebsiella species.

With the vote to repeal the Patient Protection and Affordable Care Act behind them, many Congressional leaders are focusing instead on ways to repair or eliminate some of the more contentious reform provisions.

Care for the roughly 9 million dual eligibles in this country tends to be fragmented with Medicare and Medicaid engaging in cost shifting, resulting in a lack of accountability.

FDA has approved the first drug to help prevent premature birth before 37 weeks of pregnancy in women who have had at least one previous preterm delivery.

The federal agencies charged with issuing regulations interpreting the law already have started their work.

Effecting change requires that standards of care are not only implemented, but measured and managed from patient and provider perspectives.

Fewer than a third of Americans consume the recommended five servings of fruits and vegetables per day.

Studying drugs in younger populations is challenging, and the scarcity of pediatric studies limits the ability of doctors and scientists to accurately predict drug dosing, safety and efficacy in children.

Insurance executives are observing a greater degree of anxiety among providers as they try to build their networks in an evolving era of healthcare.

Three entities - the Medicare Independent Payment Advisory Board; Center for Medicare and Medicaid Innovation; and Patient Centered Outcomes Research Institute - are examining payment mechanisms, cost containment and quality of care.

A few states have threatened to shut down Medicaid programs, and some say they won't set up local insurance exchanges if they have to meet all the requirements of the Patient Protection and Accountable Care Act.

The impact and magnitude of expenditures should have made Part D an immediate enforcement priority for the Centers for Medicare and Medicaid Services

Poor thyroid function can be treated through several drug choices.

As risk selection diminishes under health reform, risk adjustment is now becoming a superior tool in a health plan's toolbox.

FDA approved azilsartan medoxomil tablets (Edarbi, Takeda Pharmaceutical North America) to treat hypertension in adults.

Unprecedented levels of drug shortages, especially those drugs for which there are no substitutes, has prompted legislators to take action. Since the inception of the FDA Drug Shortage Program in 2000, the agency has been tracking the nation?s prescription pharmaceuticals and publishing a list of drugs in short supply.

FDA is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor because of the risk for serious maternal heart problems and death.

Merck Serono Europe informed the European Medicines Agency that it was withdrawing its marketing authorization application for oral cladribine (Movectro), 10-mg tablets, intended for the treatment of relapsing-remitting multiple sclerosis.

Forest Laboratories $1.2 billion acquisition of Clinical Data, the developer of Viibryd (vilazodone HCl) for the treatment of adults with major depressive disorder, is expected to allow Forest to leverage its existing presence in the antidepressant category.

FDA has approved Corifact (CSL Behring), the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.

FDA has granted fast-track designation to a novel endothelial cell-based therapy (Vascugel, Pervasis) for the prevention of hemodialysis access failure in patients with end-stage renal disease.

The $20.1 billion acquisition of Genzyme by Sanofi-aventis will allow Sanotif-aventis to expand its footprint in biotechnology and give it an edge in the market for drugs for rare diseases, according to experts.

Zinc, in lozenge or syrup form, is beneficial in reducing the duration and severity of the common cold in healthy people, when taken within at least 24 hours of onset of symptoms, according to a new report published in the Cochran Library.

The name change is meant to unify AmeriChoice with other Medicaid health plans under the UnitedHealthcare banner.