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Read more about the article <strong>EMA’s 2022 Highlights on Human Medicines and Advanced Therapies</strong>

EMA’s 2022 Highlights on Human Medicines and Advanced Therapies

  • Post published:February 28, 2023

Recently, the European Medicines Agency (EMA) has published its Human Medicines Highlights 2022 report, a report including figures on the authorisation of medicines and a selection of new treatments that…

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Read more about the article <strong>OTAT Town Hall events and advice on gene therapy trials</strong>

OTAT Town Hall events and advice on gene therapy trials

  • Post published:February 16, 2023

The Office of Tissues and Advanced Therapies (OTAT) from the FDA’s Center for Biologics Evaluation and Research (CBER) hosted last week a town hall answering stakeholder questions related to the…

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Read more about the article Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications

Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications

  • Post published:January 26, 2023

On 31 January 2023, the use of the Clinical Trials Information System (CTIS) will become mandatory for new clinical trial applications (CTA). It will serve as the single-entry point for…

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Read more about the article <strong>Ebvallo and Hemgenix, new ATMPs to treat post-transplant lymphoproliferative disease and haemophilia B</strong>

Ebvallo and Hemgenix, new ATMPs to treat post-transplant lymphoproliferative disease and haemophilia B

  • Post published:January 12, 2023

Recently, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions recommending the grating of a market authorization of two different Advanced Therapy Medicinal Products (ATMPs).…

Continue ReadingEbvallo and Hemgenix, new ATMPs to treat post-transplant lymphoproliferative disease and haemophilia B

Chicken Road by InOut Gaming Italian Casino Game

  • Post published:January 7, 2023

ContentAbout the Quality of the Game Support TeamMultiplier structureFrom Sketch to Screen Unlike most online casino slots, Chicken Road Game doesn’t feature classic bonus mechanics like Free Spins or Wild…

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Read more about the article <strong>New EMA Reflection paper on the evaluation of New Active Substance status of biological substances</strong>

New EMA Reflection paper on the evaluation of New Active Substance status of biological substances

  • Post published:December 15, 2022

New EMA Reflection paper on the evaluation of New Active Substance status of biological substances Recently, the EMA has published a new reflection paper reflecting the current experience on New…

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Read more about the article New FDA’s Final Guidance on Multiple Versions of Cellular or Gene Therapy Product Clinical Trials

New FDA’s Final Guidance on Multiple Versions of Cellular or Gene Therapy Product Clinical Trials

  • Post published:December 1, 2022

FDA has recently issued a new final Guidance for Industry on Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial. The purpose of this…

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Read more about the article EMA recommends authorisation of first therapy to treat rare genetic disorder

EMA recommends authorisation of first therapy to treat rare genetic disorder

  • Post published:June 16, 2022

EMA has recommended granting a marketing authorisation in the European Union for Upstaza (eladocagene exuparvovec). This is a gene therapy for the treatment of adult and paediatric patients with severe…

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Read more about the article EMA’s Update on Scientific Recommendations on Classification of ATMPs

EMA’s Update on Scientific Recommendations on Classification of ATMPs

  • Post published:May 26, 2022

Today, from Revio, we would like to share with you the latest updates on the scientific recommendations that European Medicines Agency’s Committee for Advanced Therapies (CAT) delivers on whether a…

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Read more about the article New FDA Draft Guidance on the development of CAR-T Cell Products

New FDA Draft Guidance on the development of CAR-T Cell Products

  • Post published:May 12, 2022

Today, from Revio, we would like to share with you a summary on a recent draft guidance document published by the US Food and Drug Administration (FDA): “Considerations for the…

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Revio is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs)

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