As the last line of defense against killer bugs, ViroPharma Inc.'s generics-threatened Vancocin (vancomycin) is "particularly ill-suited to being the test case" for an FDA plan to change the standards for bioequivalence testing of nonsystemically absorbed drugs. So wrote Michel de Rosen, CEO of ViroPharma, in a letter to the agency. (BioWorld Financial Watch)
Full rejoicing must wait until November, when the second - and somewhat riskier - lupus trial will report data, but Human Genome Sciences Inc. meanwhile has wowed investors with positive top-line results from a Phase III study with Benlysta (belimumab). (BioWorld Today)
Debate seemed certain to bubble this week over the future of Human Genome Sciences Inc.'s deal with Novartis AG for the lackluster hepatitis C virus candidate Albuferon, in light of news due Monday from HGS and probably from another Novartis HCV partner, Idenix Pharmaceuticals Inc.