FDAnews Drug Daily Bulletin
March 30, 2005 | Vol. 2 No. 63
The FDA is seeking advice on whether it should consider reviewing -- and possibly approving or clearing -- a new product labeled for use in conjunction with an already approved product of a different type.
Claritin has garnered more than $1 billion in U.S. sales since it was granted OTC status more than two years ago, the firm said.
Wyeth Pharmaceuticals is counting on strong demand for its vaccine Prevnar and arthritis drug Enbrel to drive its first-quarter earnings above Wall Street's expectations.
The Centers for Medicare & Medicaid Services (CMS) has tapped Linda Fishman to head its Office of Legislation -- a move that brings her back to the agency after a three-year absence.
Andrx Corporation announced that it has completed its previously announced sale and licensing of certain rights and assets related to its Fortamet and Altoprev brand pharmaceutical products to First Horizon Pharmaceutical Corporation (First Horizon).
Alnylam Pharmaceuticals, a leading RNAi therapeutics company, and Dowpharma, a business unit of The Dow Chemical Company, announced an agreement for the manufacture and supply of candidate RNAi therapeutics for Alnylam's lead development programs in age-related macular degeneration and respiratory syncytial virus infection.
Phytopharm announced that it has received confirmation from Yamanouchi Pharmaceutical Co. that as a result of a portfolio review arising out of the merger of Yamanouchi with Fujisawa Pharmaceutical Co., Yamanouchi is to terminate the licensing agreement, covering Japan and some other Asian countries, in connection with Cogane (PYM50028), Phytopharm's candidate product for the treatment of Alzheimer's disease.
Ranbaxy Pharmaceuticals, a wholly owned subsidiary of Ranbaxy Laboratories (Ranbaxy), announced that it successfully invalidated claims 1-3 (all claims sought to be invalidated) of Austrian Patent No. AT E 207 896 as anticipated by, and as lacking inventive step over, respectively, a Pfizer-owned published patent application and a Pfizer owned patent, as reflected by a decision released by the Austrian Patent Office.
TolerRx, a biopharmaceutical company focused on the discovery, development, and commercialization of novel therapies to treat patients with diseases of the immune system, announced the completion of its Series D financing.
Teragenix Corporation has launched its Latin American Initiative. This plan expands the company's already developed presence in South and Central America as one of the largest CRO's in the region.
Eisai Co. (4523.TO) said it has acquired the rights to develop, produce and market Dainippon Pharmaceutical Co.'s (4506.TO) drug for epilepsy treatment in Asia excluding Japan.
Charles River Laboratories International, Inc. announced that it has called for redemption all of its $185 million, 3.5 percent Senior Convertible Debentures due Feb. 1, 2022.
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