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Tag Archives: vaccines
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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Google Insights – A Tool for Smarter Clinical Site Selection
Every year, epidemics of the seasonal flu cause major health concerns and numerous deaths around the world. Vaccines are made in massive quantities and extra precautions are taken, such as hand washing of children in schools, in an effort to … Continue reading
Posted in Clinical Trials
Tagged clinical investigator, clinical research, clinical trials, patient recruitment, site selection, vaccines
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New Book – Principles of Anticancer Drug Development
Recently, Humana Press/Springer published a new book, Principles of Anticancer Drug Development. Neil Clendeninn M.D., Ph.D., a Senior Clinical Research Physician for Cato Research, served as an editor for the book, which has been described as a practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs. Continue reading
Posted in Publications
Tagged anticancer, cancer vaccine, Cato Research, clinical trials, drug development, FDA, pediatric, pharmacokinetics, preclinical, statistical analysis, toxicology, vaccines
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FDA Pediatric Study Information
The FDA’s Pediatric Drug Development page is a great place to find information on pediatric studies. FDA just posted the most recent metrics for studies performed between September 27, 2007 and September 30, 2010 related to the Best Pharmaceuticals for Children … Continue reading
Posted in Clinical Trials, FDA, Regulatory Strategy
Tagged clinical trials, drug development, efficacy, FDA, pediatric, safety, statistical analysis, 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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