Regulation - Asia-Pacific


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Astellas files for Japanese approval of ipragliflozin for types 2 diabetes


Japanese drug major Astellas Pharma (TYO: 4503) has submitted a market authorization application for…

Asia-PacificAstellas PharmaDiabetesipragliflozinPharmaceuticalRegulation

BioAlliance Pharma pursues development plan for Loramyc in Japan through partner Sosei


French orphan oncology and supportive care specialist BioAlliance Pharma (Euronext Paris: BIO) says its…

Antibiotics and Infectious diseasesAsia-PacificBioAlliance PharmaLoramycOravigPharmaceuticalRegulationResearchSosei

New Zealand decision to fund unapproved medicines for various conditions


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


Taiho Pharma files for approval of cancer drug TAS-102 in Japan


Japanese drugmaker Taiho Pharmaceutical, a subsidiary of Otsuka (TYO: 4768) says that it submitted an…

Asia-PacificOncologyOtsukaPharmaceuticalRegulationTaiho PharmaceuticalTAS-102

Japanese approval for Actelion's epoprostenol "ACT"


Europe's largest biotech firm Actelion (SIX: ATLN) yesterday announced that Japan's Ministry of Health,…

ActelionAsia-PacificBiotechnologyepoprostenol "ACT"RegulationRespiratory and PulmonaryVeletri

Takeda called on to take corrective action over Alinamin-F5 marketing and manufacturing


Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) revealed it has received an Order for Corrective…

Alinamin-F5Asia-PacificPharmaceuticalProductionRegulationTakeda Pharmaceuticals

Celgene's Revlimid approved in China for MM; gets PDUFA date in USA for mantle cell lymphoma


Celgene Corp's (Nasdaq: CELG) European subsidiary revealed that Revlimid (lenalidomide) has been granted…

Asia-PacificBiotechnologyCelgeneNorth AmericaOncologyRegulationRevlimid

EMA and European Commission renew confidentiality arrangement with Japan


The European Medicines Agency and the European Commission's Directorate General for Health and Consumers…


New Zealand takes significant step towards national hospital medicines list


New Zealand's Pharmaceutical Management Agency, PHARMAC, has taken a further major step towards forming…


New Zealand considers listing Merck & Co's Bridion


New Zealand's Pharmaceutical Management Agency PHARMAC is seeking feedback on a proposal to list the…

Asia-PacificBridionFinancialMerck & CoNeurologicalPharmaceuticalRegulation

Kyowa Hakko set to file for pegfilgrastim approval in Japan following strong Ph III data


Mid-size Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) on Friday released positive top-line results…

Asia-PacificBiotechnologyKyowa Hakko KirinOncologypegfilgrastimPharmaceuticalRegulationResearch

China gains WHO designation for biological products center


China's Institute for Biological Product Control (IBPC) of the National Institutes for Food and Drug…


Bayer files for Japanese approval of Eylea for macular edema following CRVO


German drug major Bayer(BAYN: DE) says its subsidiary Bayer Yakuhin has applied to the Japanese Ministry…

afliberceptAsia-PacificBayerBiotechnologyEyleaOphthalmicsPharmaceuticalRegeneronRegulationSanten Pharmaceuticals

Australian review finds more work needed on new anticoagulants


A report into anticoagulation therapies released yesterday by Australian Minister for Health Tanya Plibersek…

Asia-PacificBoehringer IngelheimCardio-vascularPharmaceuticalPradaxaPricingRegulation

Japan Tobacco files for Japanese approval of elvitegravir


Japan Tobacco (TSE:2914) has filed a New Drug Application for marketing approval of a novel anti-HIV…

Anti-viralsAsia-PacificBiotechnologyelvitegravirGilead SciencesJapan TobaccoPharmaceuticalRegulationTorii Pharma

New Zealand's PHARMAC lifts restrictions on some cancer drugs


New Zealand's Pharmaceutical Management Agency PHARMAC has removed the Special Authority funding requirements…


Trans Tasman joint therapeutic products scheme progresses


Progress towards a joint Australia and New Zealand therapeutic products regulatory scheme continued with…


Covance gains SFDA GLP Certification for its Shanghai facility; TOT opens new Suzhou plant


USA-based contract research organization (CRO) Covance (NYSE: CVD) says that its early development facility…

Asia-PacificCovancePharmaceuticalProductionRegulationResearchTOT Biopharm

Novo Nordisk's Ryzodeg passes regulatory hurdle in Japan; diabetes burden review


Global insulin market leader Novo Nordisk (NOV: N) of Denmark revealed this morning that its Ryzodeg…

Asia-PacificDegludecDiabetesGlobalHealthcareNovo NordiskPharmaceuticalPricingRegulationRyzodegTresiba

New Zealand to fund Gilead's Atripla and Truvada


New Zealand's Pharmaceutical Management Agency PHARMAC says that, effective December 1, it will fund…

Anti-viralsAsia-PacificAtriplaBiotechnologyFinancialGilead SciencesPharmaceuticalRegulationTruvada

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