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BioCryst

BioCryst Pharmaceuticals Reports MHLW Approval of Orladeyo for Hereditary Angioedema

Shots: The MHLW has approved Orladeyo (berotralstat) for prophylactic therapy in pediatric pts (2 to <12 yrs.) with hereditary angioedema (HAE) Approval was based on interim APeX-P trial results in pediatric pts with HAE, which showed early & sustained reductions in monthly attack rates; published in the Annals of Allergy, Asthma & Immunology BioCryst plans to launch…

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Pharming Group Launches Joenja in Japan for APDS

Shots: Pharming Group has launched Joenja in Japan for activated PI3K delta syndrome (APDS) patients aged 4 years and older following NHI reimbursement listing As per the agreement with Pharming, OrphanPacific serves as Joenja’s Marketing Authorization Holder in Japan &, alongside Pharming, manages the product’s supply & distribution Leniolisib is under regulatory review for pediatric…

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