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Weekly Drug News Round Up - November 5, 2014

AstraZeneca’s Xigduo XR Approved for Type 2 Diabetes

Type 2 diabetes is estimated to affect over 29 million people in America Read More...

The U.S. Food and Drug Administration (FDA) has approved once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a combination drug of two agents that work together to lower blood sugar. Dapagliflozin (Farxiga) is an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin is a biguanide. Clinical evidence of safety and efficacy for Xigduo was demonstrated in four Phase III trials, which evaluated dapagliflozin and metformin in patients who had never received either treatment, in those not well-controlled on metformin, and in patients receiving both a sulfonylurea plus metformin.

Cyramza Plus Paclitaxel Approved for Advanced Stomach Cancer

Cyramza is used already as a single agent to treat stomach cancer in patients who had failed first-line therapy Read More...

The U.S. Food and Drug Administration (FDA) today approved Cyramza (ramucirumab) plus paclitaxel to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach. A total of 665 patients were randomized to receive either Cyramza (8 mg/kg every two weeks) in combination with paclitaxel (80 mg/m2 once a week for 3 weeks of every 28-day cycle) or matching placebo plus paclitaxel. Studies with the combination of the two drugs demonstrated improved overall survival. Treatment should continue until disease progression or unacceptable toxicity.

Groundbreaking Drugs Extending Survival in Advanced Melanoma

New approvals and drug combinations are increasing survival in patients with metastatic melanoma Read More...

A clinical trial published in the Journal of the American Medical Association this week provided data on 245 patients with advanced melanoma who were randomized to treatment with intravenous ipilimumab (Yervoy) alone or Yervoy plus injections of sargramostim. Patients on the combo treatment had a median survival of 17.5 months, compared to 12.7 months for Yervoy alone. However, experts say either investigational nivolumab or recently approved pembrolizumab (Keytruda) -- used alone -- may also be effective and less toxic to extend melanoma survival even further. Early studies suggest the combo of Yervoy and nivolumab may perform well, too.

Bleeding Risks With Pradaxa and Warfarin: Study

Major bleeding occurred in 9 percent of those taking Pradaxa and nearly 6 percent of those taking warfarin Read More...

The U.S. Food and Drug Administration (FDA) approved Pradaxa (dabigatran) in 2010 to help prevent stroke and blood clots in patients with atrial fibrillation. Study results published in JAMA Internal Medicine suggest that the major bleeding risk for Pradaxa is higher than for warfarin and significantly greater than originally seen in studies evaluated at the time of FDA Pradaxa approval. In the study, stomach bleeding with Pradaxa was greater than with warfarin, but intracranial (brain) bleeding was less with Pradaxa.

Rest Assured: Generics Undergo Watchful FDA Eye

Today, more than 8 in 10 prescriptions filled in the U.S. are for generic drugs Read More...

Generic drugs can save major healthcare dollars for you -- the consumer. But how do you know they are safe? Generic drugs makers must submit data to the U.S. Food and Drug Administration (FDA) that shows their product is as safe and effective as the brand name drug. In addition, the FDA reviews scientific data on manufacturing, ingredients and performance. Quality control measures may very rarely reveal differences, such as the 2012 bioequivalence study done by the FDA that showed that the Impax/Teva Budeprion XL 300 milligram (mg) tablet, a generic version of Wellbutrin XL 300 mg, was not therapeutically equivalent to the brand.

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