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              Latest DDW Guide: Exclusive insight into cell & gene therapy

              DDW has published the first of its new Guide Series, Where is the global innovation [...]

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              New whitepaper on trends in precision medicine: Cancer

              Precision medicine uses information about an individual’s genes, proteins, and environment to prevent, diagnose, and [...]

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        Clinical Trial Authorisation

        FDA Fast Track designation for Parkinson’s Disease treatment

        20 July 2021

        BlueRock Therapeutics has been granted Fast Track designation by the US Food and Drug Administration (FDA) for DA01 for advanced Parkinson’s disease (PD). DA01, BlueRock’s pluripotent stem cell-derived dopaminergic neuron therapy, is under evaluation in a Phase I study. “Receiving Fast Track Designation from the FDA is an important step, which will help us further […]

        Moderna initiates rolling submission of Biologics License Application (BLA)

        2 June 2021

        Moderna has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application (BLA) for the licensure of its mRNA COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older. Stéphane Bancel, Chief Executive Officer of Moderna, said: “We look forward to working with the FDA […]

        Avacta announces Phase I Clinical Trial Authorisation (CTA) for AVA6000

        18 February 2021

        Avacta, the developer of Affimer biotherapeutics and reagents, has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) for its Clinical Trial Authorisation (CTA) in the UK for a Phase I study of its lead pre|CISION pro-drug, AVA6000 pro-doxorubicin. In AVA6000, doxorubicin has been modified with Avacta’s pre|CISION chemistry, which renders the modified […]

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