Almost eight months after a positive FDA panel review, AstraZeneca plc won accelerated approval Monday for Iressa (gefitinib), its epidermal growth factor receptor tyrosine kinase inhibitor pill for advanced non-small-cell lung cancer. (BioWorld Today)
SAN FRANCISCO - While the Rubber Division of the American Chemical Society was holding its 163rd spring technical meeting just down the hall at the Westin St. Francis Hotel here, members of the biotechnology industry were learning about another kind of flexibility.
Saying goodbye to biotechnology's booming "days of wine and roses," as well as the tricky "days of smoke and mirrors" that followed, industry leaders had better adopt a more realistic view of the present "days of our lives," when resources are tight and demands from partners are high. (BioWorld Today)
If government red tape makes for slow and cumbersome drug development in deals with biotechnology firms, you wouldn't know it by GenVec Inc. (BioWorld Today)
Familiarity may breed contempt in some settings, but in the prescription world it often means a leg up on competing drugs. Such appears to be the case with Enbrel (etanercept), Amgen Inc.'s rheumatoid arthritis treatment approved in 1998.
Amgen Inc. reported positive results not only on its first-quarter balance sheet but also in the first of three Phase III trials with cinacalcet HCl, a drug for secondary hyperparathyroidism partnered with NPS Pharmaceuticals Inc. (BioWorld Today)