Antigenics Pulls Oncophage Application Following CHMP Negative Opinion
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
A month after it learned that Europe's Committee for Medicinal Products for Human Use would hand down a negative opinion on approval on Oncophage (vitespen), Antigenics withdrew its Marketing Application Authorization for the cancer vaccine on Nov. 20
You may also be interested in...
Antigenics’ Oncophage Approved In Russia, First Therapeutic Cancer Vaccine To Enter Marketplace
The biologic will launch this summer at a price in the lower range of $50,000-$100,000/patient/year, the typical cost of new cancer drugs in Russia, firm tells “The Pink Sheet” DAILY.
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011
Provenge Paradox Sparks New Thinking About Immunotherapy Trials, Clinical Care
The paradoxical finding that Dendreon's cancer immunotherapeutic Provenge (sipuleucel-T) improved overall survival in men with metastatic castration-resistant prostate cancer but did not appear to slow the progression of the disease is raising questions about the future of clinical development for the burgeoning class