Regulation - Asia-Pacific, Oncology

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Astellas’ Xtandi cleared in Japan for prostate cancer treatment

24-03-2014

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

24-03-2014

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

10-02-2014

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

21-01-2014

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

16-01-2014

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

Asia-PacificBiosimilarsCellTrionGenericsHerceptinHerzumaOncologyRegulationRoche

Ono Pharma files for approval of nivolumab for melanoma in Japan

30-12-2013

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

09-12-2013

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

26-11-2013

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

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

CHMP positive decision for Kadcyla, and approval in Japan

20-09-2013

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

Asia-PacificEuropeImmunoGenKadcylaOncologyPharmaceuticalRegulationRoche

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

29-08-2013

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

20-08-2013

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

Asia-PacificBayerBiotechnologyOncologyPharmaceuticalRegulationStivarga

Venus gets GMP certifications from Ukraine

22-07-2013

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

28-06-2013

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

17-06-2013

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

31-05-2013

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

24-05-2013

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

24-05-2013

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

ActemraAnti-Arthritics/RheumaticsAsia-PacificNeulastimOncologyPharmaceuticalPricingRegulationRoche

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

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

22-03-2013

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

27-02-2013

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

12-02-2013

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

Asia-PacificBiotechnologyCelgeneNorth AmericaOncologyRegulationRevlimid

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