An estimated 30 million people in the United States are afflicted with rare (orphan) diseases or conditions; however, the availability of novel treatments for these diseases and conditions has been…
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Chimeric antigen receptor T-cell (CAR T) therapy is a revolutionary immunotherapy that uses cells from the patient’s immune system to fight certain kinds of cancer. The first two FDA approved…
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The 505(b)(2) New Drug Application (NDA) is a streamlined NDA process in which the applicant relies upon one or more investigations conducted by someone other than the applicant and for…
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What is Cellular & Gene Therapy? Genes are defined by the NIH as the “basic physical and functional unit of heredity.” We receive these valuable sequences of DNA from our…
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Clinical trials require a unique approach to public dissemination. Because clinical trials often involve the collection of sensitive information, sharing clinical trial data should always be conducted through formal and…
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During the current COVID-19 pandemic, it is important to find strategies to keep your drug development program moving forward. With many studies now paused, cancelled completely, or in the early…
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If you missed our live panel discussion on how the drug development industry is being impacted by the COVID-19 pandemic, we have assembled this post to highlight some of the…
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