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FDA NEWS

FDA approves Kerydin topical solution for onychomycosis of the toenails

FDA approves NovoSeven RT for Glanzmann's thrombasthenia

FDA: No Clear Sign of Harm with Olmesartan in Diabetics

FDA Once Again Reaches Conclusions At Odds With Its Own Staff


PBMI
SUMMARY OF TOP ARTICLES - JULY 17, 2014

U.S. senators ask Gilead Sciences to explain high cost of hepatitis C drug
LA Times - July 11, 2014
Two U.S. senators asked Gilead Sciences Inc. to produce documents explaining why its new hepatitis C drug is priced at $84,000 per treatment course, raising renewed concerns over the high costs to taxpayers.

Compounding pharmacists protest Express Scripts’ cuts
Associated Press - July 7, 2014
Compounding pharmacists are concerned about Express Scripts’ decision to stop covering around 1,000 active compounded drug ingredients used by compounding pharmacies to create topical treatments.

STUDY: Psych Drug ER Trips Approach 90,000 a Year
Associated Press - July 9, 2014
Bad reactions to psychiatric drugs result in nearly 90,000 emergency room visits each year by U.S. adults, with anti-anxiety medicines and sedatives among the most common culprits, a study suggests.

Roche skin cancer drug meets main goal in combination study
Reuters - July 14, 2014
An experimental drug from Roche helped people with an advanced form of skin cancer live longer without their disease worsening when used in combination with another treatment, the Swiss drugmaker said on Monday.

If Big Pharma Ignores Antibacterial R&D, Where Will We Get The Drugs To Treat Superbugs?
Forbes - July 11, 2014
Concerns have arisen over the fact that major pharmaceutical companies years ago had abandoned R&D in the search for new antibiotics, yet we are now at a point in time when “superbugs”, bacteria that are resistant to existing drugs, are beginning to proliferate.

"Mississippi Baby" Now Has Detectable HIV, Researchers Find
National Institutes of Health - July 10, 2014
The child known as the “Mississippi baby”—an infant seemingly cured of HIV that was reported as a case study of a prolonged remission of HIV infection in The New England Journal of Medicine last fall—now has detectable levels of HIV after more than two years of not taking antiretroviral therapy without evidence of virus, according to the pediatric HIV specialist and researchers involved in the case.

Doctors find strategies to reduce medication errors among kids
Reuters - July 14, 2014
Many kids are not taking their prescribed medications, or take an incorrect dose, due to weaknesses in the chain from prescribing to filling prescriptions to administering medication, according to a new review of past studies.

Once Again, Inaction at the FDA, Now With a New Class of Drugs, Hurts Consumers
Huffington Post - July 10, 2014
Recently, Phil DeLuca, a retired Long Island Railroad worker, was profiled on a national news television program. Suffering from a potentially fatal red blood cell deficiency, he receives a weekly shot of Procrit. Simple enough, but that shot costs a staggering $1,500, of which his co-pay is $196. That amounts to slightly under $800 a month, a hardship on the retiree but a price he has to pay. Why is the drug so expensive?

California stem cell agency to review dealings with StemCells Inc.
LA Times - July 10, 2014
California’s stem cell agency announced Wednesday it was taking steps to deal with a “risk of conflict of interest” two days after its former president took a position with a company that the state agency had been funding.

Questcor Reveals Adverse Events Data for Acthar for First Time
New York Times - July 10, 2014
For years, Questcor Pharmaceuticals has highlighted the potential benefits of Acthar, its immune-system drug, while saying little about its ill effects. But according to a regulatory filing made by Questcor early Thursday, the number of patients reporting a so-called adverse event while using the drug last year represented almost 5 percent of prescriptions dispensed.

A Spoonful of Medicine May Put Children at Risk
New York Times - July 15, 2014
Each year, about 10,000 people contact poison centers in the United States, afraid that they gave too strong a dose of medicine or were confused by measurement directions, according to the American Association of Poison Control Centers. About three-quarters of the callers are parents trying to administer medicine to children younger than 12, often baffled by such options for measuring as milliliters, milligrams, teaspoons, tablespoons and droppers.

Review of ADHD drug approvals highlights gaps between pediatric approval process and long-term safety assessment
Boston Children's Hospital - July 9, 2014
Over the last 60 years, the U.S. Food and Drug Administration (FDA) approved 20 medications for attention deficit/hyperactivity disorder (ADHD) based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events, researchers at Boston Children's Hospital report in PLOS ONE.

Severe Obesity Cuts Up to 14 Years Off Life: Study
HealthDay News - July 8, 2014
As weight climbs, so do related deaths from heart disease, diabetes and cancer, researchers say


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Email: KLavitola@PSGConsults.com

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