Back in 2008, the FDA hit developers of diabetes drugs with new guidance requiring large and costly cardiovascular outcomes study, putting several late-stage programs in limbo. Now obesity drugmakers could find themselves facing the same fate. Read More
CHICAGO – The 47th annual meeting of the American Society for Clinical Oncology began with something of an ode to targeted therapy. In data presented in a session on personalized medicine, researchers from the University of Texas MD Anderson Cancer Center showed that when end-stage cancer patients had their tumors analyzed and received targeted therapies that matched their mutations, the response rate more than quintupled and survival increased by several months. Read More
Clovis Oncology Inc. picked up another clinical-stage compound to add to its pipeline of cancer products. The Boulder, Colo.-based company will pay an undisclosed upfront fee to Pfizer Inc., plus potential milestones of $255 million, in exchange for the right to develop and commercialize the drug. In turn, Pfizer Venture Investments will make an equity investment in Clovis. Read More
WASHINGTON – Part of the price of a patent has been disclosure of trade secrets, but the patent reform bill headed for the House floor would no longer require that tit for tat. Read More
Although Anthera Pharmaceuticals Inc. already had sufficient funding to complete its ongoing Phase III trial with varespladib for acute coronary syndrome and its ongoing Phase II trial with blisibimod for lupus, the biotech raised $50 million in a public stock offering. Read More
• Cytokinetics Inc., of South San Francisco, Calif., completed a Phase IIa trial of its skeletal muscle activator, CK-2017357, in peripheral artery disease. The trial showed that CK-2017357 increased calf muscle performance in patients with calf muscle claudication associated with peripheral artery disease. Increasing calf muscle performance and adverse events were both related to increasing dose and plasma concentration of the drug. The company presented those results in a poster at the 22nd Annual Sessions of the Society for Vascular Medicine, June 2-4, Boston, Mass. Read More
• Spherix Inc., of Bethesda, Md., said SPX-106 plus D-tagatose significantly reduced triglycerides and cholesterol in mouse models of dyslipidemia. SPX-106 is a small molecule; D-tagatose is a Phase III diabetes compound originally developed as a reduced-calorie sugar substitute. Shares of Spherix (NASDAQ:SPEXD) gained 64 cents, or 19 percent, to close at $4 on Friday. Read More
