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Merck & Co submits first regulatory filing for omarigliptin, in Japan

Merck & Co submits first regulatory filing for omarigliptin, in Japan

25-11-2014

US pharma giant Merck & Co has submitted a new drug application for omarigliptin, its investigational…

DiabetesJapanMerck & CoomarigliptinPharmaceuticalRegulation

Kissei files for Japanese approval of PA21 for hyperphosphatemia

21-11-2014

Japanese mid-sized drugmaker Kissei Pharmaceutical says that a new drug application for PA21 (development…

FreseniusJapanKissei PharmaceuticalNephrology and HepatologyPA21PharmaceuticalRegulationVelphoroVifor Pharma

Bayer/Regeneron’s Eylea approved in Japan for DME

18-11-2014

German pharma major Bayer’s Japanese subsidiary, Bayer Yakuhin, has received approval from the Ministry…

BayerBiotechnologyEyleaJapanOphthalmicsRegeneronRegulation

FDA accepts Eisai's supplemental New Drug Application for Fycompa in tonic-clonic seizures

FDA accepts Eisai's supplemental New Drug Application for Fycompa in tonic-clonic seizures

20-10-2014

Japanese drug major Eisai has had a supplemental New Drug Application for its in-house-discovered AMPA…

CNS DiseasesEisaiFycompaJapanPharmaceuticalRegulation

Daiichi Sankyo seeks wider indication for Cravit in Japan

Daiichi Sankyo seeks wider indication for Cravit in Japan

03-10-2014

Japanese drug major Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) in Japan…

Antibiotics and Infectious diseasesCravitDaiichi SankyoJapanPharmaceuticalRegulation

Added indication for Daiichi Sankyo’s Lixiana in Japan

Added indication for Daiichi Sankyo’s Lixiana in Japan

29-09-2014

The Japanese Ministry of Health, Labor and Welfare has granted approval for domestic pharma major Daiichi…

Cardio-vascularDaiichi SankyoJapanLixianaPharmaceuticalRegulation

Gilead files for Japanese approval of ledipasvir/sofosbuvir for hepatitis C

24-09-2014

Gilead Sciences has submitted a New Drug Application to Japan’s Pharmaceutical and Medical Devices…

Anti-viralsBiotechnologyGilead SciencesJapanledipasvirRegulationsofosbuvir

Mitsubishi Tanabe Pharma gains approval for Telavic in genotype 2 HCV

Mitsubishi Tanabe Pharma gains approval for Telavic in genotype 2 HCV

22-09-2014

Japanese pharma company Mitsubishi Tanabe Pharma has received approval for an additional indication of…

Anti-viralsJapanMitsubishi TanabePharmaceuticalRegulationTelavic

Bayer’s Eylea approved in Japan for myopic CNV

Bayer’s Eylea approved in Japan for myopic CNV

22-09-2014

Bayer Yakuhin, the Japanese health care subsidiary if Germany’s Bayer has received approval from Japan’s…

BayerEyleaJapanOphthalmicsPharmaceuticalRegeneron PharmaceuticalsRegulation

First Ph III data in Japanese patients for Merck’s omarigliptin for type 2 diabetes

18-09-2014

US pharma giant Merck & Co has announced the presentation of the first data from the Phase III clinical…

DiabetesJapanMerck & CoomarigliptinPharmaceuticalRegulationResearch

Eisai's Fycompa launches in Belgium for partial-onset seizures

Eisai's Fycompa launches in Belgium for partial-onset seizures

04-08-2014

Fycompa (perampanel), an epilepsy drug developed by Japanese dug major Eisai, launches today in Belgium.

BelgiumCentral nervous systemEisaiEpilepsyFycompaJapanNeurologicalPharmaceuticalRegulation

Kyowa Hakko Kirin files for KW-3357 approval in Japan

Kyowa Hakko Kirin files for KW-3357 approval in Japan

01-08-2014

Japanese drugmaker Kyowa Hakko Kirin has filed an application for marketing approval with the Ministry…

HematologyJapanKW-3357Kyowa Hakko KirinPharmaceuticalRare diseasesRegulationThrombus

Astellas submits sNDA for Irribow/Irribow OD in Japan

Astellas submits sNDA for Irribow/Irribow OD in Japan

14-07-2014

Japanese drug major Astellas Pharma has submitted a supplemental New Drug Application for the indication…

Astellas PharmaGastro-intestinalsIrribowJapanPharmaceuticalRegulation

$25 million milestone for Incyte on Japanese approval of Jakavi

$25 million milestone for Incyte on Japanese approval of Jakavi

08-07-2014

US biopharma company Incyte says it has earned a $25 million milestone payment from Swiss drug major…

BiotechnologyBusiness FinanceBusiness FinanceFinancialIncyteJakaviJapanMajorMedicineNovartisOncologyRegulationRuxolitinib

Bristol-Myers hepatitis C treatment Daklinza+Sunvepra OKed in Japan

Bristol-Myers hepatitis C treatment Daklinza+Sunvepra OKed in Japan

07-07-2014

The Japanese Ministry of Health, Labor and Welfare has approved Daklinza (daclatasvir), a potent, pan-genotypic…

Anti-viralsBristol-Myers SquibbDaklinzaDaklinza+SunvepraJapanPharmaceuticalRegulationSunvepra

Japan marketing approval for Canaglu; vaccine license for Daiichi Sankyo

Japan marketing approval for Canaglu; vaccine license for Daiichi Sankyo

04-07-2014

Japanese drug major Mitsubishi Tanabe Pharma has received approval to manufacture and market the SGLT2…

canagliflozinCanagluDaiichi SankyoDiabetesJapanMitsubishi TanabePharmaceuticalRegulationSanofi PasteurVaccines

Japan first to approve Roche’s lung cancer drug alectinib

Japan first to approve Roche’s lung cancer drug alectinib

04-07-2014

The Japanese Ministry of Health, Labor and Welfare has approved Swiss pharma major Roche’s alectinib…

alectinibJapanOncologyPharmaceuticalRegulationRoche

Gilead submits for approval of hepatitis C drug Sovaldi in Japan

Gilead submits for approval of hepatitis C drug Sovaldi in Japan

27-06-2014

US biotech firm Gilead Sciences revealed this morning it has submitted a New Drug Application to Japan's…

Anti-viralsBiotechnologyGilead SciencesJapanRegulationSovaldi

Eisai files first marketing application for lenvatinib in Japan

Eisai files first marketing application for lenvatinib in Japan

26-06-2014

Japanese pharma major Eisai said today that it has submitted its first marketing authorization application…

EisaiJapanlenvatinibOncologyPharmaceuticalRegulation

Bayer’s Nexavar cleared in Japan for differentiated thyroid cancer

Bayer’s Nexavar cleared in Japan for differentiated thyroid cancer

20-06-2014

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved German pharma major Bayer’s oral…

BayerJapanNexavarOncologyPharmaceuticalRegulation

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