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CSL Behring’s Hizentra approved in Japan for PID and SID

CSL Behring’s Hizentra approved in Japan for PID and SID


The Japanese Ministry of Health, Labor and Welfare has approved Hizentra for the treatment of primary…

Asia-PacificCSL BehringHizentraImmunologicalsPharmaceuticalRare diseasesRegulation

Alexion's Soliris gets approval in Japan for rare disorder


The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved Soliris (eculizumab) from US drugmaker…

Alexion PharmaceuticalsAsia-PacificPharmaceuticalRare diseasesRegulationSoliris

New Zealand reaches agreement with Sanofi to fund ALS drug


New Zealand's Pharmaceutical Management Agency PHARMAC has announce the approval of an agreement with…

Asia-PacificNeurologicalPharmaceuticalRare diseasesRegulationRilutekSanofi

New Zealand to widen access for type 1 and type 3 Gaucher disease drug


New Zealand's Pharmaceutical Management Agency PHARMAC has announced the approval of a proposal to widen…

Asia-PacificBiotechnologyCerezymeGenzymePharmaceuticalRare diseasesRegulationSanofi

Japanese filings for Shionogi's metreleptin and Otsuka's tolvaptin


Japanese drugmaker Shionogi (TYO: 4507) said last week that it has filed a New Drug Application with…

Asia-PacificmetreleptinNephrology and HepatologyOtsukaPharmaceuticalRare diseasesRegulationSamscaShionogitolvaptin

EMA increases interaction with Japanese regulators


The European Medicines Agency has increased its level of interaction and cooperation with medicines regulatory…

Asia-PacificBiotechnologyEuropePharmaceuticalRare diseasesRegulation

Teijin and Ipsen's Somatuline cleared in Japan


Japanese drugmaker Teijin Pharma (TYO: 3402) revealed last Friday that it has received manufacturing…

Asia-PacificIpsenPharmaceuticalRare diseasesRegulationSomatulineTeijin

Actelion drops setipiprant, gets miglustat approval in Japan


Switzerland-based Actelion Ltd (SIX: ATLN) announced says that it will re-direct its development efforts…

ActelionAsia-PacificBiotechnologyBrazavesInflammatory diseasesMiglustatRare diseasesRegulationResearchsetipiprantZavesca

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