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Pharming receives agreement of Paediatric Investigation Plan and Promising Innovative Medicine designation for leniolisib from UK MHRA

Operational updates

An agreed Paediatric Investigation Plan (PIP) is the regulatory pathway to market authorization for leniolisib as a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS) in children. A Promising Innovative Medicine (PIM) designation is an early indication that leniolisib is a candidate for the MHRA’s Early Access to Medicines Scheme

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Pharming Group and Sanofi renew strategic manufacturing partnership agreement

Operational updates

Pharming announces that it has renewed its strategic manufacturing partnership with long-term manufacturing partner Sanofi S.A. The extended 5-year contract which includes options for extensions, ensures the continuation of the downstream processing in the production of RUCONEST®, a recombinant C1 inhibitor product approved for the acute treatment of hereditary angioedema.

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