Regulatory - International Biopharmaceutical Industry

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Streamlining IND Applications for Cell and Gene Therapy Innovations

Cell and gene therapies (CGTs) are quickly emerging as valuable approaches for the treatment of complex diseases. The development of these treatments, especially Adv...

23 September 2024 news Cell and Gene Therapy | Regulatory

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Volume 5 Issue 3

Why Regulatory Convergence is Key to Global Development of Cell and Gene Therapies

There is growing excitement about the potential shown by cell and gene therapies, particularly in rare diseases. First, though, these therapies face challenges both i...

12 October 2022 Volume 5 Issue 3 achieving | advanced

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Volume 4 Issue 3

Regulatory Challenges Associated with the Development of Cell and Gene Therapies

The development of safe and effective cell and gene therapies (CGTs) relies on regulatory compliance and critical selection and qualification of raw materials. Regula...

1 September 2021 Volume 4 Issue 3 cell and gene therapies | cell therapies

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Sparks sells regulatory fast pass to Jazz for $110M

Brief: Spark Therapeutics has sold a priority review voucher (PRV) to Jazz Pharmaceuticals for $110 million, according to a Monday disclosure. While details wer...