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First Asian approval for ophthalmic drug Jetrea, in Malaysia

18-04-2014

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

AlconAsia-PacificBiotechnologyJetreaMalaysiaNovartisOphthalmicsRegulationThromboGenics

Australian regulator finds no definite melanoma link for natalizumab

Australian regulator finds no definite melanoma link for natalizumab

18-03-2014

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

13-03-2014

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

23-11-2013

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

22-11-2013

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

14-10-2013

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

Asia-PacificBiotechnologyRegulation

Bayer gets Japanese OK for GI stromal tumors drug

20-08-2013

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

Asia-PacificBayerBiotechnologyOncologyPharmaceuticalRegulationStivarga

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

New Zealand consults on Victrelis listing and some Pegasys amendments

19-07-2013

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

12-07-2013

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

01-07-2013

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

17-06-2013

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

16-05-2013

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

Asia-PacificBiotechnologyFinancialPharmaceuticalRegulation

New Zealand considers listing of Neulastim and Actemra

12-04-2013

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

ActemraAnti-Arthritics/RheumaticsAsia-PacificBiotechnologyNeulastimOncologyPharmaceuticalPricingRegulationRoche

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

14-03-2013

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"

19-02-2013

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

12-02-2013

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

07-02-2013

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

Asia-PacificBiotechnologyEuropePharmaceuticalRegulation

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

28-01-2013

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

28-01-2013

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

Asia-PacificBiotechnologyKyowa Hakko KirinOncologypegfilgrastimPharmaceuticalRegulationResearch

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