Regulation - Asia-Pacific, Oncology


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Astellas’ Xtandi cleared in Japan for prostate cancer treatment


Japanese drug major Astellas Pharma has obtained the marketing approval in Japan of its oral androgen…

Asia-PacificAstellas PharmaJapanMedivationOncologyPharmaceuticalRegulationXtandi

Japanese approval for Forxiga and Lonsurf


Anglo-Swedish drug major AstraZeneca says that Japanese Ministry of Health, Labor and Welfare approved…

Asia-PacificAstraZenecaDiabetesForxigaJapanLonsurfOncologyOno PharmaceuticalOtsukaPharmaceuticalRegulationTaiho Pharmaceutical

Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP

Roche sues Biocon and Mylan over Herceptin biosimilar; US puts pressure on India over IP


Swiss pharma major Roche’s Indian subsidiary has sued Bangalore-based Biocon and US generics firm Mylan…

Asia-PacificBioconBiosimilarsCanmabHerceptinHertrazIndiaLegalMylan LaboratoriesOncologyPatentsPharmaceuticalRegulationRoche

Norgine and Kissei’s Savene approved in Japan


Independent Dutch firm Norgine and its Japanese partner Kissei Pharmaceutical received approval from…

Asia-PacificKissei PharmaceuticalNorgineOncologyPharmaceuticalRegulationSavene

Celltrion’s trastuzumab biosimilar, Herzuma, approved in South Korea


South Korean biopharmaceutical firm Celltrion has received approval for its cancer treatment biosimilar…


Ono Pharma files for approval of nivolumab for melanoma in Japan


Japanese drugmaker Ono Pharmaceutical has filed an application to obtain a manufacturing and marketing…

Asia-PacificBristol-Myers SquibbnivolumabOncologyOno PharmaceuticalPharmaceuticalRegulation

New Zealand funding plans for Tarceva and Revolade

New Zealand funding plans for Tarceva and Revolade


Following a consultation, New Zealand’s Pharmaceutical Management Agency PHARMAC said this morning…

Asia-PacificGlaxoSmithKlineHematologyNew ZealandOncologyPharmaceuticalPricingRegulationRevoladeRocheTarceva

Mylan-Biocon Herceptin biosimilar gets first Indian approval

Mylan-Biocon Herceptin biosimilar gets first Indian approval


US generic major Mylan says that its partner, India-based biotechnology firm Biocon has received approval…

Asia-PacificBioconBiosimilarsGenericsHerceptinHertrazMylan LaboratoriesOncologyRegulationRoche

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

CHMP positive decision for Kadcyla, and approval in Japan


The cancer drug Kadcyla (trastuzumab emtansine) has today received a positive opinion from the European…


Daiichi Sankyo files Ranmark to treat giant cell tumor of bone in Japan


Japanese drug major Daiichi Sankyo (TYO: 4568) has filed an application for approval in Japan to manufacture…

AmgenAsia-PacificDaiichi SankyoOncologyPharmaceuticalPraliaRanmarkRegulation

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…


Venus gets GMP certifications from Ukraine


Indian R&D-based drugmaker Venus Remedies (BSE: 526953) has been able to gain a Good Manufacturing Practice…

Antibiotics and Infectious diseasesAsia-PacificEuropeMarkets & MarketingOncologyPharmaceuticalProductionRegulationVenus Remedies

Chugai gains Japanese approval for Perjeta and Bonviva


Japanese drugmaker Chugai Pharmaceutical (TYO: 4519) said this morning (June 28) that it has obtained…

Anti-Arthritics/RheumaticsAsia-PacificBonvivaChugai PharmaceuticalOncologyPerjetaPharmaceuticalRegulationRoche

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

Kyowa Hakko launches PD drug Nouriast and files for additional indication of fluorouracil in Japan


Japanese drugmaker Kyowa Hakko Kirin (TYO: 4151) say that it launched its novel Parkinson's disease drug…

Asia-PacificfluorouracilKyowa Hakko KirinMarkets & MarketingNeurologicalNouriastOncologyPharmaceuticalRegulation

Astellas and Medivation file for approval of enzalutamide in Japan


Japanese drug major Astellas Pharma (TYO: 4503) has submitted an application for marketing approval of…

Asia-PacificAstellas PharmaenzalutamideMedivationOncologyPharmaceuticalRegulationXtandi

Proposal to list Roche's Neulastim and Actemra in New Zealand


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


New Zealand considers listing of Neulastim and Actemra


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


Takeda files for brentuximab vedotin approval in Japan; sanctioned by JPMA


Japan's largest drugmaker, Takeda Pharmaceutical (TYO: 4502) and its oncology subsidiary Millennium have…

AdcetrisAlinamin-F5Asia-PacificbrentuximabMillennium LaboratoriesOncologyPharmaceuticalRegulationSeattle GeneticsTakeda Pharmaceuticals

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

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

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