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Tag Archives: monoclonal antibody therapy
Fifth China Medicinal Biotech Forum – Conference Recap
I recently returned from the Fifth China Medicinal Biotech Forum held in Beijing, China from 07-09 November 2011. The purpose of this conference was to update graduate students in China on the latest trends in biotechnology. This forum also allowed … Continue reading
Posted in Clinical Trials, Conferences and Meetings
Tagged biologics, biosimilar, biotech, China, clinical research, clinical trials, conference, DNA, efficacy, FDA, gene therapy, immuno, manufacturing, monoclonal antibody therapy, NIH, Phase 1, recombinant proteins, safety
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2010 New Drug Approvals
The U.S. FDA’s Center for Drug Evaluation and Research (CDER) approved 21 new products in 2010 – slightly less than the previous year’s 24 – plus 5 biologics approved by CBER. In light of the FDA’s continued focus on drug safety, I am not surprised that the number isn’t higher. A full list of approvals can be found here.
While the list isn’t long, a few new products stand out to me. Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged biologics, BLA, cancer vaccine, CBER, CDER, clinical trials, FDA, marketing application, monoclonal antibody therapy, NDA, safety, vaccines
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Cato at the Cancer Vaccines Meeting
This week, Cato Research is attending the Cancer Vaccines meeting in Cambridge, MA on 29 and 30 June. The conference is the first meeting dedicated to progressing cancer vaccines to market and will feature 21 of the world’s leading experts … Continue reading
Posted in Conferences and Meetings
Tagged cancer, Chemotherapy, clinical trials, immune system, monoclonal antibody therapy, pancreatic cancer, vaccines
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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
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