Survey

With healthcare reform creating an FDA approval pathway for 'biosimilar' agents in the United States, what do you see as the primary implications of this from a managed care perspective in the next 3 years?

1) No impact, as I don't see any changes occurring soon

2) Limited savings with only a small number of products and small number of manufacturers

3) Moderate savings with the introduction of several products at moderate discounting to innovator brands

4) Significant savings with several biosimilar options, significant discounts and enhanced rebating from innovator brands

Digital Edition

Merck halts vorapaxar study over bleeding concerns in stroke victims

Concern that its potential clot-preventing drug vorapaxar increased the risk of bleeding in stroke victims has prompted Merck & Co. to halt a late-stage study of the drug, the Associated Press reported. Read full article.

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FDA sends complete response letter to MannKind regarding new inhaler

FDA has sent MannKind Corp. a complete response letter regarding the company’s NDA for Afrezza Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia. Read full article.

Formulary design, individual mandate key to healthcare reform law

With the healthcare reform law repeal exercise behind them, Congressional leaders can get down to focusing on ways to eliminate or repair some of the more contentious reform provisions and to modify others, according to policy watchers. Read full article.

FDA approves head lice treatment for children and adults

FDA approved spinosad (Natroba, ParaPRO LLC) Topical Suspension 0.9% for the treatment of head lice infestation in patients aged 4 years and older. Read full article.

FDA approves vilazodone HCl for MDD

FDA has approved vilazodone HCl tablets (Viibryd, Clinical Data) for the treatment of adults with major depressive disorder. Read full article.

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