Regulation - Asia-Pacific, Biotechnology


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First Asian approval for ophthalmic drug Jetrea, in Malaysia


Belgian biotech firm ThromboGenics NV revealed today that Jetrea (ocriplasmin) has been approved in Malaysia…


Australian regulator finds no definite melanoma link for natalizumab

Australian regulator finds no definite melanoma link for natalizumab


Australia’s Therapeutic Goods Administration revealed today that it is monitoring reports of melanoma…

Asia-PacificAustraliaBiogen IdecBiotechnologyNatalizumabNeurologicalRegulationTysabri

Taiwan’s TaiGen Biotech receives domestic marketing approval for Taigexyn


Taiwan-based drug developer TaiGen Biotechnology says that the Taiwan Food and Drug Administration has…

Antibiotics and Infectious diseasesAsia-PacificBiotechnologyRegulationTaiGen BiotechTaigexyn

Drug approvals for Bayer in USA and Japan

Drug approvals for Bayer in USA and Japan


There were two pieces of good news for German Pharma and chemicals major Bayer on Friday (November 22),…

AmgenAsia-PacificBayerBiotechnologyEyleaNexavarNorth AmericaOncologyOnyx PharmaceuticalsOphthalmicsPharmaceuticalRegeneronRegulation

New legislation for regenerative medicine in Japan

New legislation for regenerative medicine in Japan


The Japanese legislature (Diet) has approved new legislation targeted at regenerative medicine therapies.…

Asia-PacificBiotechnologyCytori TherapeuticsLegalRegulationResearch

Stem cell rules clear and adequate, says Philippines FDA

Stem cell rules clear and adequate, says Philippines FDA


The Philippines Food and Drug Administration (PFDA) has said its guidelines governing stem cell therapy…


Bayer gets Japanese OK for GI stromal tumors drug


German drug major Bayer (BAYN: DE) has received approval from the Ministry of Health, Labor and Welfare…


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

New Zealand consults on Victrelis listing and some Pegasys amendments


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

Anti-viralsAsia-PacificBiotechnologyMerck & CoPegasysPharmaceuticalRegulationRocheVictrelis

GlaxoSmithKline and Theravance withdraw Japan NDA for Relvar Ellipta in COPD


UK pharma giant GlaxoSmithKline (LSE: GSK) and US partner Theravance (Nasdaq: THRX) revealed on Friday…

Asia-PacificBiotechnologyGlaxoSmithKlinePharmaceuticalRegulationRelvar ElliptaRespiratory and PulmonaryTheravance

Briefs: BioMarin files Vimizim in Brazil; Kyowa Hakko submits KRN125 in Japan; Insmed's Arikace update


USA-based BioMarin Pharmaceutical (Nasdaq: BMRN) has submitted the Vimizim (BMN-110, elosulfase alfa)…

Asia-PacificBioMarin PharmaceuticalBiotechnologyInsmedKRN125Kyowa Hakko KirinPharmaceuticalRegulationResearchSouth AmericaVimizim

Additional indications in Japan for Roche's Avastin and Astellas' Prograf


Swiss drug major Roche (ROG: SIX) says that the Japanese Ministry of Health, Labor and Welfare (MHLW)…

Asia-PacificAstellas PharmaAvastinBiotechnologyImmunologicalsOncologyPharmaceuticalPrografRegulationRoche

Australia's revised code to benefit ASX-listed life science companies


Australia's Minister for Technology, Gordon Rich-Phillips, this week joined forces with the Australian…


New Zealand considers listing of Neulastim and Actemra


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


Consultation opens for Australian code of best practice for life science companies


Trade group AusBiotech and the Australian Securities Exchange (ASX), with the support of the Victorian…

Asia-PacificBiotechnologyMarkets & MarketingPharmaceuticalRegulation

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

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 approves funding of sildenafil for Raynaud's phenomenon and bosentan for children with PAH


New Zealand's Pharmaceutical Management Agency PHARMAC has approved proposals for funding Pfizer's (NYSE:…

ActelionAsia-PacificBiotechnologybosentanFinancialPfizerPharmaceuticalRegulationRespiratory and PulmonaryRevatiosildenafilTracleer

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

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