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Orphan Unknowns: What the MHRA Guidance Will Mean After Brexit

Developers of orphan drug products face some important changes with the approval process in the UK after Brexit. To help companies prepare, the MHRA published new guidance: “How the MHRA will manage orphan medicinal products from 1 January 2021 in Great Britain (GB)”. While most of the criteria to qualify for orphan drug designation align …

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Innovative Research Meets and Overcomes Milestones

BMS announced FDA and EC approvals for their innovative CAR T Cell Therapy for R/R Multiple Myeloma earlier this year. A ground-breaking achievement that gives many people new hope. The emergence of targeted and precision therapies has increased treatment options for people living with cancer. CAR T-cell therapy is a novel treatment, so little is …

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