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FDA APPROVALS

FDA approves Blincyto to treat a rare form of acute lymphoblastic leukemia

FDA Approves Xgeva (denosumab) for Hypercalcemia of Malignancy Refractory to Bisphosphonate Therapy


FDA NEWS

FDA Issues New Drug Label Rules to Better Inform Pregnant Women

Specialty Rx
SUMMARY OF TOP ARTICLES - DECEMBER 11, 2014

Employer Premium and Deductible Cost Growth Slowed Post-ACA, But Employer Health Insurance Still Claiming Bigger Share of Workers' Income
The Commonwealth Fund - December 9, 2014
Premiums for employer-sponsored health insurance grew 4.1 percent per year between 2010 and 2013, following passage of the Affordable Care Act, compared to 5.1 percent per year between 2003 and 2010, before the law was passed, according to a new Commonwealth Fund report. But since U.S. family incomes have grown even more slowly, workers are spending more of their income on their employer health insurance.

Flu Shot May Offer Less Protection This Winter: CDC
HealthDay News - December 4, 2014
This flu season looks like it could be worse than usual, due to an aggressive strain of influenza virus that might flout the protection provided by this year's vaccine, U.S. health officials warned Thursday.

Feds refuse to hear Sandoz case related to biosimilar development efforts
BioPharma Dive - December 10, 2014
On July 24, Sandoz became the first company to file for biosimilar approval in the U.S. under the FDA's 351(k) pathway.

Injectable 3-D vaccines could fight cancer, infectious diseases
ScienceDaily - December 8, 2014
A non-surgical injection of programmable biomaterial that spontaneously assembles in vivo into a 3-D structure could fight and even help prevent cancer and also infectious disease such as HIV, scientists have demonstrated.

Old And Overmedicated: The Real Drug Problem In Nursing Homes
NPR - December 8, 2014
It's one of the worst fears we have for our parents or for ourselves: that we, or they, will end up in a nursing home, drugged into a stupor. And that fear is not entirely unreasonable.

Text Messages Remind People to Take Medications
HealthDay News - December 5, 2014
Fewer than one in 10 forgot their daily dose after cellphone prompt, study says.

The FDA's new effort to make it easier to create generics of risky drugs
BioPharma Dive - December 5, 2014
Risk Evaluation and Mitigation Strategy (REMS) is a program set up by the FDA to ensure safe use of potentially dangerous drugs.

Exchange Plans Increase Costs of Specialty Drugs for Patients in 2015
Avalere Health - December 2, 2014
A new analysis from Avalere Health finds that patients accessing specialty medications – drugs often used to treat life threatening illnesses, such as cancer, rheumatoid arthritis, or multiple sclerosis – through exchange plans are more likely to experience higher out-of-pocket costs in 2015 than in 2014.

U.S. Doctors Cutting Back on Painkiller Prescriptions: Study
HealthDay News - December 8, 2014
Ninety percent of primary care physicians are concerned about abuse of powerful narcotics.


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Pharmaceutical Strategies Group (PSG)
Office: 972-943-7141
Email: JTankersley@PSGConsults.com

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