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Novavax Announces COVID-19 Vaccine Clinical Development Progress

The Pharma Data

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K. GAITHERSBURG, Md.,

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AGC and RoosterBio partner for cell and exosome therapy manufacturing

Pharmaceutical Technology

These capabilities comprise cell and exosome genetic engineering for expressing therapeutic targets. In order to offer complete process development, quality control and regulatory services, cGMP manufacturing for pre-clinical and Phase I/II clinical trials, AGC will use its worldwide network.

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Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA

The Pharma Data

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. President of Research and Development, Novavax.

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Targovax announces formation of new Scientific Advisory Board

The Pharma Data

Clynes developed several novel therapeutic approaches in cancer and autoimmunity, including DC targeting for cancer vaccines and Syk and JAK mediated inhibition of DCs and T cells in autoimmunity therapy. Dean A.

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Biopharma Leaders Unite To Stand With Science

The Pharma Data

Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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Biopharma Leaders Unite To Stand With Science

The Pharma Data

— Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US.

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Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval

Advarra

Gene therapy has achieved notable successes, particularly in treating resistant or refractory B cell leukemias (achieving overall response rates around 90% or greater) and the speed with which COVID-19 vaccines were developed under the original Operation Warp Speed. Why Warp Speed for Rare Diseases?