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FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate), developed progressive multifocal leukoencephalopathy (PML), a rare and serious brain infection, and later died. As a result, information describing this case of PML is being added to the Tecfidera drug label.

There’s no hiding that hospital pharmacies have long been considered cost centers for healthcare systems. That positioning has been accentuated over the past 5 years, as the healthcare industry has seen a steady increase in high-cost, brand-name specialty medications that range from hundreds to thousands, sometimes tens of thousands, of dollars per dose. Nearly every hospital, however, has untapped opportunities to substantially improve efficiencies and improve costs. One important factor is improving how these hospitals use generic medications.

Melanoma, an aggressive disease with a rapidly rising incidence rate, presents the oncology field with some of its greatest challenges and opportunities. Long considered one of the most difficult diseases to treat with pharmacotherapy, drug development within melanoma has lagged behind that of many other cancers, culminating in decades of limited progress. Developments in molecular biology, however, have led to an increased understanding of the molecular heterogeneity of melanoma in recent years, which has resulted in new insights into the roles of oncogenes, signaling pathways, immune checkpoints, and tumor-promoting events, accelerating the rate of discovery of therapeutic targets.

An extended-release (ER) opioid analgesic, hydrocodone bitartrate (Hysingla ER, Purdue Pharma) has been approved by FDA for the management of pain severe enough to require daily, 24-hour, long-term opioid treatment. Alternative treatment options must also have been found to be inadequate.

Treating skin cancer is having a major impact on the US healthcare system. The costs associated with skin cancer increased 5 times as fast as treatments for other cancers between 2002 and 2011, according to a Centers for Disease Control study published November 9 online in the American Journal of Preventive Medicine.

Myalept (metreleptin) is a leptin analogue with the same physiologic effects as leptin.11 Metreleptin was granted a priority review and was FDA approved on February 25, 2014, as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired lipodystrophy.

FDA announced that it will review results from a clinical trial showing that long-term dual antiplatelet therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment.

Investigational drug LCZ696 (Novartis), an angiotensin receptor neprilysin inhibitor (ARNI), is superior to angiotensin-converting enzyme (ACE) inhibitor alone in reducing the risks of death and of hospitalization for heart failure, according to data presented at the American Heart Association's (AHA) Scientific Sessions in Chicago.

It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.

The new combination hepatitis C drug ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) has been found to be highly effective in treating patients with cirrhosis who have not benefited from previous therapies.

The shortage of saline solution among hospitals is ongoing and doesn’t appear to be resolving anytime soon, according to a quality executive with the American Society of Health-System Pharmacists (ASHP). In addition, safety concerns make it prohibitive for hospitals to compound their own solutions.

FDA has approved a first-of-its-kind, personalized blood test to predict the likelihood of organ rejection in children with liver or intestine transplants (Pleximmune). The test was developed by researchers at Children’s Hospital of Pittsburgh of UPMC to determine a personalized rejection-risk index with cell-based technology.