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Orphan Unknowns: What the MHRA Guidance Will Mean After Brexit

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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

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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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