ARTICLE | Finance

Regulatory milestones

Highlights of weekly biotech stock moves

November 15, 2010 8:00 AM UTC

Dendreon Corp. (NASDAQ:DNDN) gained $0.06 to $35.13 last week after a technology assessment released for this Wednesday's meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) said there is moderately strong evidence that Provenge sipuleucel-T improves clinical outcomes in prostate cancer patients. Reviewers also concluded that there is "insufficient" evidence for Provenge in any off-label indications. The immunotherapy is approved to treat asymptomatic or minimally symptomatic metastatic hormone refractory prostate cancer. Provenge costs $93,000 for a three-dose course of treatment(see Online Links, A21).

Endo Pharmaceuticals Holdings Inc. (NASDAQ:ENDP) lost $0.18 to $35.71 last week after FDA said it no longer sees a need to convene an advisory committee meeting on Dec. 2 to discuss an NDA for an extended-release, crush-resistant formulation of oxymorphone. The product is under Priority Review to treat moderate to severe pain in patients requiring continuous opioid treatment for an extended period of time, with a Jan. 7 PDUFA date...