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Otsuka Holdings Co Ltd (4578.T)

4578.T on Tokyo Stock Exchange

5,310JPY
18 May 2018
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Latest Key Developments (Source: Significant Developments)

Otsuka's tolvaptan approved by U.S. FDA as first treatment to slow kidney function decline in adults at risk of rapidly progressing ADPKD
Wednesday, 25 Apr 2018 

April 25 (Reuters) - Otsuka Holdings Co Ltd <4578.T>:Says its unit Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the U.S. Food and Drug Administration (FDA) has approved JYNARQUE™ (tolvaptan) as the first drug treatment available to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).  Full Article

Otsuka's JYNARQUE Approved By FDA As First Treatment to Slow Kidney Function Decline
Wednesday, 25 Apr 2018 

April 24 (Reuters) - Otsuka Pharmaceutical::U.S. FDA APPROVED JYNARQUE AS DRUG TREATMENT TO SLOW KIDNEY FUNCTION DECLINE IN ADULTS AT RISK OF RAPIDLY PROGRESSING ADPKD.  Full Article

Otsuka Pharmaceutical Says Co, X-Chem Have Signed Collaborative Research Agreement To Advance Discovery Process For New Otsuka Drug Compounds
Wednesday, 20 Dec 2017 

Dec 19 (Reuters) - Otsuka Holdings Co Ltd <4578.T>::OTSUKA PHARMACEUTICAL SAYS CO, X-CHEM INC HAVE SIGNED COLLABORATIVE RESEARCH AGREEMENT TO ADVANCE DISCOVERY PROCESS FOR NEW OTSUKA DRUG COMPOUNDS.  Full Article

GW Pharmaceuticals Reacquires Full Rights To Develop And Commercialize Sativex In U.S.
Wednesday, 13 Dec 2017 

Dec 13 (Reuters) - GW Pharmaceuticals Plc ::GW PHARMACEUTICALS REACQUIRES FULL RIGHTS TO DEVELOP AND COMMERCIALIZE SATIVEX® IN U.S..GW PHARMACEUTICALS - NOW REACQUIRED FULL OWNERSHIP OF DEVELOPMENT, COMMERCIALIZATION RIGHTS TO PRODUCT IN U.S. WITHOUT UPFRONT PAYMENT TO OTSUKA​.GW PHARMACEUTICALS - ‍AGREED TO MAKE CONTINGENT MILESTONE PAYMENTS TO OTSUKA, FIRST OF WHICH WOULD BECOME DUE UPON FDA APPROVAL OF SATIVEX​.GW PHARMACEUTICALS PLC - ‍TERMINATION OF PREVIOUS LICENSE AGREEMENT WITH OTSUKA PHARMACEUTICAL CO IN RELATION TO SATIVEX IN U.S.​.  Full Article

Otsuka Holdings to transfer medical device business to unit
Tuesday, 14 Nov 2017 

Nov 14 (Reuters) - Otsuka Holdings Co Ltd <4578.T>:Says co plans to transfer medical device business to co's wholly owned unit Otsuka Medical Devices Co Ltd, with effective date of Jan. 1, 2018.Says unit will issue 80,000 shares of its common stock to the co.  Full Article

FDA accepts Otsuka's resubmission to support a regulatory review of Tolvaptan in the treatment of ADPKD
Thursday, 9 Nov 2017 

Nov 9 (Reuters) - Otsuka Holdings Co Ltd <4578.T>:FDA accepts Otsuka's resubmission to support a regulatory review of Tolvaptan in the treatment of ADPKD.‍otsuka Pharmaceutical - FDA accepts Otsuka's resubmission to support a regulatory review of tolvaptan in treatment of adpkd​.Otsuka Holdings Co Ltd - ‍April 2018 is anticipated completion timing of FDA's review based on PDUFA timeline ​.  Full Article

Otsuka Canada Pharmaceutical says Health Canada approves Otsuka and Lundbeck's Abilify Maintena as treatment for bipolar I disorder in adults​
Friday, 3 Nov 2017 

Nov 2 (Reuters) - Otsuka Holdings Co Ltd <4578.T> -:Otsuka Canada Pharmaceutical Inc-Health Canada approves Otsuka and Lundbeck's Abilify Maintena as treatment for bipolar I disorder in adults​.  Full Article

Otsuka Holdings unit and Lundbeck to initiate third Phase 3 trial to evaluate brexpiprazole in treatment of agitation in patients with dementia of Alzheimer's type
Wednesday, 1 Nov 2017 

Nov 1 (Reuters) - Otsuka Holdings Co Ltd <4578.T>:Says co's unit Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S will initiate a third clinical phase 3 study for brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer's type, in the first half of 2018.  Full Article

Health Canada grants priority review status to trifluridine and tipiracil for refractory metastatic colorectal cancer
Friday, 20 Oct 2017 

Oct 20 (Reuters) - Otsuka Holdings Co Ltd <4578.T>:Taiho Pharma Canada - Health Canada accepted for review new drug submission for trifluridine, tipiracil,NDS granted priority review status​.Taiho Pharma Canada - Health Canada's review of NDS under priority review is expected to be completed in early 2018​.  Full Article

Otsuka and Lundbeck announce initiation of two phase 3 trials of brexpiprazole in patients with bipolar I disorder
Thursday, 12 Oct 2017 

Oct 12 (Reuters) - Otsuka Holdings Co Ltd <4578.T>:unit Otsuka Pharmaceutical Co., Ltd. and Lundbeck announce that patient enrollment has been initiated in two global Phase 3 clinical trials to evaluate brexpiprazole for the treatment of patients with manic episodes associated with bipolar I disorder.  Full Article

BRIEF-Otsuka Pharmaceutical Says Co, X-Chem Have Signed Collaborative Research Agreement To Advance Discovery Process For New Otsuka Drug Compounds

* OTSUKA PHARMACEUTICAL SAYS CO, X-CHEM INC HAVE SIGNED COLLABORATIVE RESEARCH AGREEMENT TO ADVANCE DISCOVERY PROCESS FOR NEW OTSUKA DRUG COMPOUNDS Source text for Eikon: Further company coverage: