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Weekly Drug News Round Up - July 23, 2014

Gilead’s Zydelig Approved as Fifth Breakthrough Therapy

Zydelig carries a Boxed Warning alerting patients and providers of fatal and serious toxicities Read More...

The U.S. Food and Drug Administration (FDA) today approved Zydelig (idelalisib) to treat patients with three types of blood cancers: relapsed chronic lymphocytic leukemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma (FL), and relapsed small lymphocytic lymphoma (SLL). In clinical trials, patients with relapsed CLL who were treated with orphan drug Zydelig and Rituxan lived 10.7 months without disease progression compared to roughly 5.5 months for patients treated with placebo and Rituxan. The FDA has approved two other breakthrough therapies for CLL in the last 9 months: Gazyva (obinutuzumab) and Imbruvica (ibrutinib). In April 2014 Arzerra (ofatumumab) was also given a green light for CLL.

Orphan Drug Ruconest Approved for Hereditary Angioedema

Hereditary angioedema is due to low amounts of a plasma protein called C1-esterase inhibitor and is considered a rare disease Read More...

The U.S. Food and Drug Administration (FDA) has approved Ruconest (C1-Esterase Inhibitor) for the treatment of acute attacks of hereditary angioedema (HAE) in adult and adolescent patients. Ruconest is a recombinant version of the human protein C1 inhibitor (C1INH). HAE attacks can be most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation (suffocation). Ruconest restores C1-esterase inhibitor in a patient’s plasma, thereby treating the acute attack of swelling. The most common adverse reactions were headache, nausea and diarrhea. Firazyr (icatibant) was also approved in 2011 for HAE.

Painful Autoimmune Arthritis Can Affect Kids, Too

Juvenile idiopathic arthritis is an autoimmune disease; the immune system attacks the body’s own tissues Read More…

Close to 300,000 children nationwide have a diagnosis of juvenile idiopathic arthritis. Just as with arthritis in adults, it can be painful; common symptoms include joint pain and swelling, tenderness, and inflammation. Knees, wrists, ankles, small joints and even the whole body can be affected. New biologic treatments are making major inroads: for example, between 2008 and 2013, five biologics were approved for use in either systemic or polyarticular Juvenile Idiopathic Arthritis, including Humira (adalimumab), Orencia (abatacept), Enbrel (etanercept), Actemra (tocilizumab), and Ilaris (canakinumab). Like adults, biologics used in children can lead to the risk of serious infections and tuberculosis.

Doctors Need More Training on Influenza Treatment: Study

The elderly, very young, pregnant women and people with certain chronic diseases like asthma are considered at high risk of flu complications Read More...

A new study headed up by the Centers for Disease Control and Prevention (CDC) shows that in the 2012-13 flu season, antiviral medications were under prescribed and antibiotics may have been inappropriately prescribed to many influenza sufferers. Researchers looked at data from roughly 6,800 patients with flu symptoms. The team focused on prescription records for two antiviral drugs for flu --oseltamivir (Tamiflu) and zanamivir (Relenza) -- and three widely used antibiotics (amoxicillin-clavulanate, amoxicillin, and azithromycin). Only 19 percent of patients received antivirals, while 30 percent inappropriately received antibiotics, which are ineffective for influenza.

Antibiotic-Resistant Superbug Soaring in Southeastern Hospitals

The death rate from carbapenem-resistant Enterobacteriaceae infections is nearly 50 percent Read More...

The numbers of a highly contagious bacteria known as carbapenem-resistant Enterobacteriaceae (CRE) are increasing in community hospitals found in the southeastern part of the U.S. CRE bacteria are resistant to most common antibiotics and are considered "one of the three greatest threats to human health," according to the World Health Organization. CRE bacteria can cause infections in the urinary tract, lungs, blood and other areas. Greater use of broad-spectrum antibiotics is one of the factors associated with the growing number of CRE infections and other dangerous antibiotic resistance.