regulatory

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Leqembi maintenance dose filed in US, but SC form delayed

Eisai has filed to extend the label for its Alzheimer’s disease therapy Leqembi to include a maintenance dosing regimen that would reduce the number of intravenous infusio

Patients

Case Study: MHRA and AstraZeneca

Agile, responsive regulation helps early breast cancer patients to benefit from a study to potentially improve survival outcomes.

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Nanoscope preps filing for retinitis pigmentosa gene therapy

Nanoscope Therapeutics is on the brink of filing for FDA approval of what could be the first gene therapy for incurable eye disease retinitis pigmentosa (RP) that can be u

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Eisai and Biogen facing delay to Leqembi in Europe

Around 14 months after Eisai and Biogen’s Leqembi was filed for approval in the EU, the bloc’s regulatory authority has delayed making a decision on the Alzheimer’s drug.

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EU pharma legislation reforms inch closer to fruition

A key hurdle in front of the EU reforms to pharma legislation has fallen, after the European Parliament’s Environment, Public Health and Food Safety (ENVI) committee appro

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