FDAnews Drug Daily Bulletin
March 23, 2005
| Vol.
2 No.
58
Biogen Idec's and Elan's recent withdrawal of multiple sclerosis (MS) drug Tysabri is starting to have some fallout for other drugmakers, including GlaxoSmithKline (GSK), which has been ordered to halt a clinical trial of a drug candidate in the same class as Tysabri. Biogen Idec's multiple sclerosis (MS) drug Avonex can cause severe liver damage, including liver failure, according to a MedWatch alert released by the FDA. Pharmaceutical firms need to do a better job of helping the public understand drug risks, according to pharmaceutical executives. The Centers for Medicare & Medicaid Services issued a final decision memorandum extending Medicare coverage to Praecis Pharmaceuticals' prostate cancer drug Plenaxis. Biolex, a privately held protein therapeutics company, announced a broad-based, multileveled strategic alliance with Centocor, Inc., a leading biopharmaceutical company, to manufacture selected proteins using the Biolex LEX System. GlaxoSmithKline and Medco Health Solutions announced an innovative collaboration designed to provide broad access to GSK's medicines through Medco's proposed CMS offering as a National Prescription Drug Provider (PDP). Dutch biotechnology company Crucell N.V. today announced the signing of a commercial PER.C6 license agreement with Singapore-based company SingVax Pte Ltd for the development and commercialization of new vaccines against Japanese encephalitis. OSI Pharmaceuticals Inc. is planning to nearly triple the size of its workforce over the next three years. Billionaire financier Carl Icahn is about to reclaim his crown as Mylan Laboratories' largest shareholder. Drugmaker Pfizer Inc. announced Tuesday it plans to end production at its Holland, Mich., plant and sell off the facility. If a buyer cannot be found, the facility will be closed in late 2006. A small group of Eli Lilly and Co. shareholders that includes a nun and the 1,000-woman congregation of Adrian Dominican Sisters wants the drugmaker to split its corporate structure at the very top. In a press release, the biopharmaceutical company said the reductions will allow the company to prepare for a planned partnership of Estrasorb, its topical emulsion for estrogen therapy. |
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