The industry is caught between wanting numerous questions answered in the text and a rapid implementation of new rules to end the current fragmented regulatory “nightmare” that currently exists in Europe.
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When submitting and IND for CGT product/therapy, it’s crucial to confirm that the viral vector in use is appropriate, especially…
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In the ever-evolving landscape of pharmaceuticals/biopharmaceuticals, manufacturing changes play a pivotal role in ensuring the quality and effectiveness of medicinal…
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ATMPs (Advanced Therapeutic Medicinal Products) in Europe, or CGTs (Cell and Gene Therapies) as they are known in the US,…
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The recent announcement of BlueBirdBio to wind down its European commercialisation efforts due to access and pricing challenges for its…
