• Abbott, of Abbott Park, Ill., received FDA approval to market Humira (adalimumab) to reduce the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years and older. That approval is based on 48-week clinical data showing that fewer children treated with Humira experienced disease flare compared to placebo.
• Adherex Technologies Inc., of Research Triangle Park, N.C., received orphan drug designation for ADH-1 for its use in conjunction with melphalan in Stage IIb/C, Stage III and Stage IV malignant melanoma. That designation would guarantee seven years of marketing exclusivity upon approval in the U.S. Adherex is conducting a Phase IIb expansion trial of ADH-1 in combination with regional melphalan. It is expected to complete patient accrual around mid-2008.
• Arcadia Biosciences Inc., of Davis, Calif., and Bioriginal Food and Science Corp., of Saskatoon, Saskatchewan, formed a strategic partnership to market High GLA Safflower Oil. GLA is an omega-6 fatty acid with health benefits that are similar and complementary to the benefits of omega-3 fatty acids. Under the terms, Arcadia will produce the safflower oil and Bioriginal will have exclusive marketing and sales rights.
• Artisan Pharma Inc., of Waltham, Mass., said its lead drug, ART-123 (human, soluble recombinant thrombomodulin) was approved in Japan in disseminated intravascular coagulation. ART-123 is partnered in Japan with Asahi Kasei Pharma Corp., of Tokyo. Outside of Japan, Artisan is continuing with an 800-patient Phase IIb trial and recently initiated efforts to seek corporate partners in other select markets.
• Elixir Pharmaceuticals Inc., of Cambridge, Mass., reported new data on the role of ghrelin antagonism in the regulation of metabolism, with data showing that ghrelin receptor knockout mice on a high fat diet demonstrated improved insulin sensitivity compared to wild type mice, as measured using the hyperinsulinemic euglycemic clamp and a newly development hyperglycemic clamp. Those data, presented at Keystone Symposia's meeting on glucose metabolism and body weight in Banff, Alberta, indicate the potential of ghrelin antagonists in Type II diabetes.
• Medistem Laboratories Inc., of Scottsdale, Ariz., reported a paper published in Expert Opinion on Biological Therapy, describes methods of selectively inhibiting pathological immune responses in arthritis patients. Medistem's lead product, a menstrual blood-derived stem cell (endometrial regenerative cell) that appears to modulate pathological immune responses, is undergoing investigative tests.
• Nycomed US Inc., of Melville, N.Y., completed its acquisition of Bradley Pharmaceuticals Inc., of Fairfield, N.J. That deal allows Nycomed to expand its line of dermatological products.
• Xenomics Inc., of Monmouth Junction, N.J., granted Warnex Medical Laboratories nonexclusive rights in Canada to offer NPM1 testing as a laboratory service for the diagnosis, stratification and monitoring of acute myeloid leukemia patients. A recent discovery showed that many AML patients have mutations in the NPM1 gene, a favorable marker for clinical outcome. The mutation might also be used to monitor AML patients for residual disease during chemotherapy. Financial terms of the deal were not disclosed.