Regulation - Asia-Pacific, Daiichi Sankyo

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Daiichi Sankyo submits edoxaban application to the EMA for stroke prevention

Daiichi Sankyo submits edoxaban application to the EMA for stroke prevention

08-01-2014

Japanese drug major Daiichi Sankyo (TYO: 4568) has submitted a Marketing Authorization Application to…

Asia-PacificCardio-vascularDaiichi SankyoedoxabanPharmaceuticalRegulation

Ban on FDA-regulated drugs from Ranbaxy's Mohali plant

17-09-2013

There was another blow for India's largest drugmaker Ranbaxy Laboratories (BSE: 500359) yesterday (September…

Asia-PacificDaiichi SankyoGenericsNorth AmericaProductionRanbaxy LaboratoriesRegulation

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

Japan vaccines briefs: Gardasil and Cervarix; Daiichi Sankyo files NDA

21-06-2013

The Japanese Ministry of Health, Labor and Welfare has decided to withdraw its recommendation for a vaccination…

Asia-PacificCervarixDaiichi SankyoGardasilGlaxoSmithKlineMerck & CoPharmaceuticalRegulationVaccinesWomen's Health

Daiichi Sankyo files for Japanese approval of Prasugrel

18-06-2013

Japanese drug major Daiichi Sankyo (TYO: 4568) says that it has submitted a New Drug Application to the…

Asia-PacificCardio-vascularDaiichi SankyoEffientEli LillyPharmaceuticalprasugrelRegulation

US DoJ says Ranbaxy pleads guilty and agrees to pay $500 million in settlements

14-05-2013

In the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA, a subsidiary…

Asia-PacificDaiichi SankyoFinancialGenericsLegalNorth AmericaProductionRanbaxy LaboratoriesRegulation

Daiichi Sankyo updates on PRASFIT-Elective study, NDA filing

14-03-2013

Japanese drug major Daiichi Sankyo (TYO: 4568) says that the follow-up period for the Phase III PRASFIT-Elective…

Asia-PacificAspirinCardio-vascularDaiichi SankyoEffientPharmaceuticalprasugrelRegulationResearch

Daiichi Sankyo to file prasugrel in Japan next year, following strong results

25-09-2012

Japanese drug major Daiichi Sankyo (TYO: 4568) has announced data from the PRASFIT-ACS study, a double-blind…

Asia-PacificCardio-vascularDaiichi SankyoPharmaceuticalprasugrelRegulationResearch

Daiichi Sankyo files denosumab in Japan for osteoporosis

26-03-2012

Japanese drug major Daiichi Sankyo (TYO: 4568) revealed on Friday that it has filed for approval in Japan…

AmgenAnti-Arthritics/RheumaticsAsia-PacificDaiichi SankyodenosumabPharmaceuticalRegulation

Additional indications in Japan for Diagnogreen and Sawacillin

22-02-2012

Japanese drug major Daiichi Sankyo (TYO: 4568) says it has received approval in Japan for a supplemental…

Antibiotics and Infectious diseasesAsia-PacificAstellas PharmaDaiichi SankyoPharmaceuticalRegulationSawacillin

Japanese approval for Regnite and Ranmark

18-01-2012

Japanese drug major Astellas Pharma (TYO: 4503) and USA-based XenoPort (Nasdaq: XNPT) revealed yesterday…

AmgenAsia-PacificAstellas PharmaAstraZenecaBiotechnologyDaiichi SankyodenosumabFinancialNeurologicalOncologyPharmaceuticalRanmarkRegniteRegulationXenoPort

Backing for Japanese approval of Regnite, Ranmark and Cancidas

05-12-2011

USA-based XenoPort (Nasdaq: XNPT) saw its shares rise 3% to $4.73 on Friday, when the company said it…

Antibiotics and Infectious diseasesAsia-PacificCancidasDaiichi SankyodenosumabHorizantMerck & CoOncologyPharmaceuticalRegniteRegulationXenoPort

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