FDA says company can assess its safety in people.Maxim Makes FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Leap: Investors raised Maxim Pharmaceuticals' stock 27 cents to close at $8.80 on April 14 after the FDA granted the San Diego-based biotech bi·o·tech n. Informal Biotechnology. biotech Noun short for biotechnology Noun 1. permission to treat critically ill cancer patients with its melanoma melanoma: see skin cancer. melanoma Dark-coloured malignant tumour of skin cells that produce the protective skin-darkening pigment melanin. drug Ceplene. That comes after federal regulators rejected Ceplene for approval in 2001. Maxim said April 14 as part of the limited FDA approval news that it will adopt a program to treat patients who have run out of treatment options with Ceplene and chemotherapy. The protocol will be available to eligible patients in the United State and qualified treatment centers in coming months, Maxim wrote. Maxim estimated net costs of $1.5 million for the current fiscal year to make the drug available. The actual financial impact will depend on the number of enrolled patients and rate of reimbursement, the company said. The FDA said it would reimburse costs for Maxim's effort to provide Ceplene to eligible patients. Separately, Maxim said it expects to complete its Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA study of 230 patients whose cancer has spread to the liver by year-end. Maxim plans to use the data from the study--which compares the effectiveness of the combined Ceplene and chemotherapy to giving chemotherapy alone--to try to win final approval. Malignant melanoma Malignant Melanoma Definition Malignant melanoma is a type of cancer arising from the melanocyte cells of the skin. Melanocytes are cells in the skin that produce a pigment called melanin. is the deadliest form of skin cancer with 7,900 people succumbing to the disease every year in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. alone. There are no effective treatments, Maxim said. Maxim's stuck closed at $9.29 on April 19. Contact Marion Webb via e-mail at mwebb@sdbj.com or call her at (858) 277-6359, Ext. 3108. |
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