Tag:
Provenge
Latest Headlines
Latest Headlines
Dendreon to pursue Provenge approval
Shares of Seattle-based Dendreon got a boost on Wednesday when the biotech company announced it would file for FDA marketing approval for its new prostate cancer drug Provenge. Dendreon officials said that in talks with agency officials, the FDA said that the data from two Phase III trials for Provenge could support an NDA. Trial results from earlier in the year showed that patients taking Provenge had longer survival times compared to a placebo.- read this story from the Seattle Post-Intelligencer for more
Dendreon's Provenge gets mixed grade in second Phase III
Dendreon announced that final three-year survival data from its second Phase III study of Provenge, the company's immunotherapy for prostate cancer, showed a survival benefit in men with advanced disease. Men taking the drug had a 20 percent better survival rate than those who received placebo, but these findings were not statistically significant. A secondary analysis adjusted for factors known to influence survival did, however, meet criteria for statistical significance. This is …
ALSO NOTED: Isis inks deal with Pfizer; Ortho-McNeil touts trial results;Guidant discloses malfunction; and much more...
> Isis Pharmaceuticals will pocket a million-dollar payment from Pfizer in a new collaboration aimed at employing its antisense therapies in developing new treatments. Isis also stands to gain milestones and royalties in the deal. Story > Ortho-McNeil has told a meeting of the American …
