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Tag Archives: clinical benefit
Accelerated Approval
Image via Wikipedia One must strike the right balance between speed and quality. – Clare Short Accelerated approval has been in the news for a while, so it seems like a good time to go over some of the basics: … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged accelerated approval, clinical benefit, DDMAC, efficacy, FDA, postmarketing, safety, surrogate endpoint
1 Comment
Approval of Therapeutic Cancer Vaccines
Last month, Dendreon was granted approval for Provenge®, the first cell based cancer vaccine for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. Provenge is the first cancer treatment that utilizes the strength of the … Continue reading
Posted in FDA, Industry News, Publications
Tagged biomedical, cancer, Cancer Advances, cancer vaccine, Cato BioVentures, clinical benefit, clinical development, Dendreon, drug development, gastric cancer, gastrointestinal cancers, immune system, immunomodulators, Journal for Clinical Studies, monoclonal antibody therapy, pancreatic cancer, Provenge, serum-derived polyclonal treatment, targeted therapeutics, tumors
1 Comment
