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Formulary, A peer-reviewed drug management journal for managed care and hospital decision-makers
Part of the Modern Medicine Network

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FormularyJournal.com

September 16, 2011

Formulary
Home Medication Safety FDA Actions Latest News Policy Watch Drug Watch
In This Issue
FDA issues label change for TNF-alpha blockers to include risk of infection from Legionella and Listeria
FDA panel recommends approval of rivaroxaban for stroke prevention
Lower-dose colchicine may benefit patients with first recurrence of pericarditis
M-EDTA demonstrates efficacy in prevention of CRB for hemodialysis patients
FDA issues CRL to Janssen Biotech for golimumab sBLA

Survey

This month we would like to know...

With the recent announcement of Medco's acquisition by Express Scripts, potentially bringing 2 of the nation's largest PBMs together, what do you see as the most significant implications of such consolidation for the industry?

a) Enhanced competition within the industry, inevitably translating to even lower drug costs for PBM payer clients.

b) Unfair advantages for Express Scripts based upon its size, thus reducing competition and potentially increasing long-term costs for payers.

c) Increased pressures on retail pharmacies forcing more pharmacies out of business.

d) Increased quality of PBM clinical, analytic and administrative services across the industry, as other PBMs strive to stay competitive.

e) Minimal, if any, impact.

Click Here to Vote

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FDA issues label change for TNF-alpha blockers to include risk of infection from Legionella and Listeria

FDA has notified healthcare professionals that the Boxed Warning for the entire class of tumor necrosis factor-alpha (TNF-alpha) blockers has been updated to include the risk of infection from 2 bacterial pathogens, Legionella and Listeria. Read full article.

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FDA panel recommends approval of rivaroxaban for stroke prevention

An FDA advisory panel voted 9-2 (with 1 abstention) to recommend approval for rivaroxaban (Xarelto, Johnson & Johnson and Bayer AG), an oral, once-daily anticoagulant, as a treatment to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Read full article.

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Lower-dose colchicine may benefit patients with first recurrence of pericarditis

Colchicine is a safe and effective treatment for patients who have had a first recurrence of pericarditis, according to a recent study published August 28, in the Annals of Internal Medicine. Read full article.

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M-EDTA demonstrates efficacy in prevention of CRB for hemodialysis patients

An antimicrobial lock solution containing minocycline in combination with EDTA  (M-EDTA) reduces the rate of catheter-related bacteremia (CRB) in hemodialysis patients, according to the results of a study published online in the Journal of the American Society of Nephrology. Read full article.

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FDA issues CRL to Janssen Biotech for golimumab sBLA

FDA issued a complete response letter (CRL) for a golimumab (Simponi, Janssen Biotech) supplemental Biologics License Application (sBLA) seeking an expanded label in the treatment of active psoriatic arthritis. Read full article.

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