Tag:
Dendreon
Latest Headlines
Latest Headlines
Dendreon plans to raise $59M to market Provenge
Dendreon plans to sell 10 million shares of common stock in a deal aimed at raising $59 million before expenses. The Seattle-based drug developer will use much of the money to commercialize its experimental prostate-cancer drug Provenge, which it plans to file an application on next year.- read this article from the Seattle Times for more …
Prostate cancer drug gets Fast Track designation
The FDA has awarded Fast Track designation to Dendreon for its prostate cancer drug Provenge. Results from the phase III study show that Provenge could improve the survival rates of men with asymptomatic, metastatic, androgen-independent prostate cancer. Each year prostate cancer kills over 30,000 men.- read this press release for more
Dendreon to push for approval of Provenge for prostate cancer
Dendreon said it will push ahead with plans to seek FDA approval of its prostate cancer drug Provenge after discussing the latest Phase III data with regulators. Final results for Provenge were released at the European Cancer Conference in Paris. Earlier this year some analysts had noted that Dendreon might have to mount a third Phase III trial to satisfy the FDA.- read this AP report for more
SPOTLIGHT: Analysts bullish on biotech
Analysts said that biotech companies are well positioned to reap the benefits of new licensing and buyout deals as product-hungry pharma companies seek them out. Picks include BioCryst, Dendreon, Nabi, Onyx, Amylin and others. Report
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 …
