Regulation - Asia-Pacific, Rare diseases

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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

27-09-2013

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

13-09-2013

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

11-09-2013

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

07-08-2013

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

06-08-2012

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

30-07-2012

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

01-07-2012

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

04-04-2012

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

ActelionAsia-PacificBiotechnologyBrazavesInflammatory diseasesMiglustatRare diseasesRegulationResearchsetipiprantZavesca

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