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Solid Tumor CAR-T & AMD Gene Therapy Win EMA PRIME Designations

Executive Summary

The first half of 2022 saw a total of seven promising treatments for unmet medical needs make it onto the European Medicines Agency’s priority medicine scheme.

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Adverum Makes Job Cuts To Advance Wet AMD Gene Therapy

The California-based biotech is reducing its workforce to help finance a Phase II study of Ixo-vec, its eye gene therapy which has been blighted by safety concerns.

PRIME Dry Spell Over As EMA Says Yes To Pfizer & BioCryst

This year’s first designations under the European Medicines Agency’s priority medicines scheme have gone to a maternal vaccine for an infection in newborns and a treatment for an ultra-rare bone disorder.

Three-Month Dry Spell For EU PRIME Scheme

Not one of the applications reviewed by the European Medicines Agency this year for a place on its scheme for drugs for unmet medical needs has made the grade. Meanwhile, the agency recently explained how applicants could improve their chances of getting accepted on the initiative.

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