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Celgene Announces Positive Top Line Data From Randomized Controlled Phase II Study Of Apremilast In Psoriatic Arthritis
Celgene Corporation (NASDAQ: CELG) announced the preliminary results of a phase II, multi-center, randomized, double-blind, placebo-controlled, three-arm study of apremilast - a novel, orally available small molecule that exhibits anti- inflammatory activities through the suppression of multiple pro-inflammatory mediators and cytokines - in adult patients with psoriatic arthritis (CC-10004-PSA-001). The study met its primary objective of assessment of ACR20 at 12 weeks. ACR20 is defined as the percentage of patients achieving a 20% or better improvement according to the American College of Rheumatology (ACR) criteria. ACR20 is the primary assessment utilized by the U.S. Food and Drug Administration for assessment of efficacy in psoriatic arthritis, as well as rheumatoid arthritis.
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BIO Commends Senate Committee On Small Business And Entrepreneurship's SBIR Reauthorization
Under legislation reported by the Senate Committee on Small Business and Entrepreneurship, small companies that receive the majority of their financing from venture capital will once again be considered eligible to compete for Small Business Innovation Research (SBIR) grants. The change will allow more small biotechnology start-ups to compete for these funds and continue critical research and development of medical advancements and breakthroughs. Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood made the following statement today:
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Op-Ed: Pres. Obama's Ghana Trip, Africa Policy
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Public Health

Medicare Revamps Competitive Bidding Program

The Centers for Medicare & Medicaid Services is preparing to revive competitive bidding program for durable medical equipment that industry members helped sink last summer when it was originally scheduled to take effect, CQ HealthBeat reports. The agency had anticipated a 26 percent savings for wheelchairs, oxygen tanks and other pieces of equipment through the program. But a lobbying group for the suppliers, the American Association for Homecare, successfully urged Congress to shut down the program before it went into effect. Now the group is doing it again. The association "predicts that resumption of the program will have the same impact as the first round of bidding, which it said would have radically thinned the ranks of suppliers in the participating markets before Congress blew the whistle on the program and ordered changes," CQ reports (Reichard, 6/2). McKnight"s Long-Term Care News reports that CMS has improved the program with new on-line bid submission and oversight features (6/2). This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org. © Henry J. Kaiser Family Foundation. All rights reserved.


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