PSG RxWire
Advancing and protecting our clients' interests in the pharmacy benefit marketplace for more than 20 years.
FDA APPROVALS

Avycaz, new antibacterial drug

Toujeo, once-daily basal insulin

Liletta (levonorgestrel-releasing intrauterine system) to prevent pregnancy for up to three years


FDA NEWS

FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients

FDA cautions about using testosterone products for low testosterone due to aging

FDA Launches Drug Shortage App


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SUMMARY OF TOP ARTICLES - MARCH 5, 2015

King v. Burwell: Interpreting five words in the ACA
DOTmed News - March 5, 2015
Oral arguments concluded yesterday in a Supreme Court case with the potential to bring the Affordable Care Act to its knees.

Gilead seals generic Sovaldi deal with Natco, NICE rec for Harvoni in UK
BioPharma Dive - March 3, 2015
Gilead has reached a deal with India-based Natco Pharma to sell generic Sovaldi (sofosbuvir), generic Harvoni (combo sofosbuvir and ledipasvir), as well as an experimental drug, GS-5816, in 91 developing countries.

Hearing Notice: Examining the 340B Drug Pricing Program
U.S. House Committee on Energy and Commerce - February 25, 2015
Subcommittee members will hear testimony from witnesses from the Health Resources and Services Administration, the Government Accountability Office, and the Department of Health and Human Services Office of the Inspector General about the 340B program, a federal drug discount program.

Does Long-Term Acetaminophen Use Raise Health Risks?
HealthDay News - March 2, 2015
Acetaminophen may not be as safe as previously thought, with larger doses and long-term use linked to increased risk of health problems, a new report contends.

Cholesterol Count Results: Most Americans Don't Know LDL-C Levels
Sanofi - February 19, 2015
Despite the fact that high LDL-C (bad cholesterol) is a critical heart health factor for adults,1 71 percent of Americans surveyed are not sure of or do not recall their LDL-C levels, according to the initial results from the Cholesterol Counts Poll released during American Heart Month.

'Cadillac' tax likely to diminish union health plans, study finds
Modern Healthcare - March 2, 2015
Health plans obtained through union collective bargaining agreements often include much more generous benefits than other employer-sponsored plans. But such benefits are likely to be pared down as the Affordable Care Act's excise tax nears, a new study in Health Affairs contends.

Skin Patch Shows Promise in Easing Peanut Allergy
HealthDay News - February 22, 2015
A wearable patch that safely and gradually exposes the body to small amounts of peanut allergen appears effective in easing the allergy, an early new study shows.

FDA is Urged to Withdraw Fungal Drug Over Serious Liver Risks
Wall Street Journal - February 25, 2015
A consumer advocacy group has asked the FDA to immediately withdraw oral formulations of a decades-old fungal medicine over concerns that serious liver damage outweighs “questionable” benefits.

Psychiatric Drug Overuse Is Cited by Federal Study
New York Times - March 1, 2015
Federal investigators say they have found evidence of widespread overuse of psychiatric drugs by older Americans with Alzheimer’s disease, and are recommending that Medicare officials take immediate action to reduce unnecessary prescriptions.

Benzodiazepines: Helpful or Harmful?
U.S. News & World Report - February 19, 2015
A recent study found 1 in 20 adults received a prescription for benzodiazepines in 2008.

Women Fooled By Untested Hormones From Compounding Pharmacies
Forbes - February 20, 2015
According to a new study, an estimated 28 million to 39 million prescriptions are filled each year for hormone-replacement therapies made by compounding pharmacies. But two large Internet surveys reveal that a staggering 86% of women don’t understand that products sold by compounding pharmacies are not approved by the U.S. Food & Drug Administration.


Contact,

Jan Tankersley
Senior Vice President, Marketing & Sales
Pharmaceutical Strategies Group (PSG)
Office: 972-943-7141
Email: JTankersley@PSGConsults.com

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