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Weekly Drug News Round Up - January 29, 2014

Xtandi Study Stopped Early Due to Clear Benefit in Prostate Cancer

In 2012, the FDA approved Xtandi for use in men with advanced prostate cancer who had previously received chemotherapy Read More...

New research shows that the drug Xtandi (enzalutamide) increased survival by 29 percent and delayed disease progression by 81 percent in men with advanced prostate cancer who had not received treatment with chemotherapy. In the new study 1,700 men received Xtandi or placebo. Results show that the median time to disease progression has not been reached after 20 months of follow-up for the group receiving Xtandi; the disease progressed in only four months for the placebo group. The median survival time at first analysis was 32.4 months for the Xtandi group and 30.2 months for placebo. Other hormone therapy drugs for prostate cancer include Casodex (bicalutamide), Eulexin (flutamide) and Nilandron (nilutamide).

FDA Advisory Panel Backs Merck’s Ragwitek for Ragweed Allergies

In the U.S, ragweed season starts in early September and runs through the fall Read More...

Current treatment for ragweed allergy includes a variety of nasal sprays, as well as shots specifically tailored to target all of a patient's hay fevers. On Tuesday, an FDA advisory committee recommended approval of an investigational immunotherapy drug named Ragwitek (Short Ragweed Pollen Allergen Extract) for ragweed allergy. The sublingual (under the tongue) tablet is taken daily beginning 12 weeks prior to ragweed pollen season, and continued throughout. The advisory committee voted positively that Ragwitek meets efficacy and safety endpoints; however, some experts are concerned the agent may not target other types of grass and pollen allergies these patients often face.

FDA Consumer Update: Head Lice May Return Each January

Roughly 6 to 12 million U.S. cases of head lice infestation occur each year in children 3 to 11 years of age Read More...

Head lice are actually a year-round problem, and the number of cases peak when the kids go back to school in the fall and in January after Christmas. Head lice are not caused by poor hygiene, but by direct contact with a person who already has head lice. FDA-approved treatments for head lice include both over-the-counter (OTC) and prescription drugs, such as Nix and Rid, in the form of shampoos, creams and lotions. Some treatments are not for use in children under two, so read label directions closely. In addition, your doctor may prescribe drugs recently approved by the FDA, such as Ulesfia, Natroba, or Sklice.

Consuming Omega-3 Fish Oils May Protect Brain Cells

Research shows that consuming omega-3 fatty acid fish oils may help to protect the aging brain, but why this occurs is still a mystery Read More...

In an observational study published in the journal Neurology, researchers tested levels of omega-3 fatty acids in the red blood cells of more than 1,000 older women. Eight years later, the women had MRI scans that measured their brain volumes. Participants whose omega-3 levels were twice as high had a 0.7 percent higher brain volume. Experts suggest that the effect on brain volume is the equivalent of delaying the normal loss of brain cells that comes with aging by one to two years. To boost their omega-3 fish oil intake people can eat nonfried 'oily' fish such as salmon, herring, tuna and sardines at least twice a week.

FDA Approves New Dosing and Formulation for Teva’s Copaxone

Copaxone is a self-injectable protein used to treat and prevent relapse of multiple sclerosis Read More...

The U.S. Food and Drug Administration (FDA) has approved Teva Pharmaceutical’s Copaxone (glatiramer) for three-times-a-week dosing using Copaxone 40mg/mL, a new dose strength. This new formulation will allow for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis (MS). In addition to the newly approved dose, daily Copaxone 20 mg/mL will continue to be available. Generic versions of the 20 mg/mL dose form are expected to be available in May 2014 as patent protection for the blockbuster is set to expire in May 2014. Copaxone ranked as the top selling MS drug of 2012 with over $3.3 billion in sales.

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