News Releases

2015

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Dec.18.2015
Initiating AVERT-2 Study in Japan, an International Phase IIIb Clinical Study of Orencia in Previously Untreated Rheumatoid Arthritis Patients (74.5KB)
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Dec.17.2015
ONO receives manufacturing and marketing approval partial amendment approval for OPDIVO® (generic name: nivolumab) for treatment of patients with unresectable, advanced or recurrent non-small cell lung cancer in Japan (82.2KB)
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Dec.11.2015
ONO submits manufacturing and marketing approval partial amendment application for OPDIVO® (generic name: nivolumab) for treatment of patients with unresectable or metastatic renal cell carcinoma in Japan (33.5KB)
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Dec.09.2015
Amgen Submits Application In Europe To Expand Indication Of Kyprolis® (carfilzomib) For The Treatment Of Relapsed Multiple Myeloma (29.4KB)
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Dec.02.2015
Bristol-Myers Squibb Announces Regulatory Update for Opdivo (nivolumab) in Advanced Melanoma (149KB)
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Dec.01.2015
HELSINN ANNOUNCES EUROPEAN MEDICINES AGENCY ACCEPTANCE OF MARKETING AUTHORIZATION APPLICATION FOR ANAMORELIN HCL (37.8KB)
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Nov.30.2015
Bristol-Myers Squibb Announces U.S. Food and Drug Administration Approval for Opdivo (nivolumab) as a Single Agent for the Treatment of Patients with Previously Untreated BRAF Wild-Type Advanced Melanoma (180KB)
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Nov.25.2015
Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab), the Only Treatment to Deliver Significant Overall Survival in Advanced Renal Cell Carcinoma vs. a Standard of Care, in Patients Who Have Received Prior Anti-Angiogenic Therapy (176KB)
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Nov.25.2015
New Long-Term Data on Opdivo and the Opdivo + Yervoy Regimen Shows Survival Benefit Across Lines of Therapy in Advanced Melanoma (183KB)
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Nov.24.2015
European Commission Approves Kyprolis® (carfilzomib) For Combination Use In The Treatment Of Patients With Relapsed Multiple Myeloma (21.4KB)
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Nov.17.2015
U.S. Food and Drug Administration Accepts for Priority Review the Supplemental Biologics License Application for Opdivo (nivolumab) in Patients with Advanced Renal Cell Carcinoma (172KB)
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Nov.06.2015
European Medicines Agency Validates Bristol-Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) in Previously Treated Advanced Renal Cell Carcinoma (129KB)
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Nov.04.2015
Announcement on Financial Results for FY2015 2Q
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Oct.30.2015
Bristol-Myers Squibb's Opdivo (nivolumab) Recipient of Prix Galien USA 2015 Award for Best Biotechnology Product (147KB)
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Oct.26.2015
Revisions of Consolidated Financial Forecasts (25.8KB)
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Oct.14.2015
Bristol-Myers Squibb's Opdivo (nivolumab) Receives Expanded FDA Approval in Previously-Treated Metastatic Non-Small Cell Lung Cancer (NSCLC), Offering Improved Survival to More Patients (171KB)
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Oct.05.2015
Bristol-Myers Squibb Receives Approval from the U.S. Food and Drug Administration for the Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Unresectable or Metastatic Melanoma (205KB)
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Sep.30.2015
Opdivo (nivolumab) Demonstrates Long Term Survival Benefit in Patients with Previously Treated Non-Squamous Non-Small Cell Lung Cancer in CheckMate -057 (147KB)
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Sep.29.2015
Bristol-Myers Squibb Announces U.S. Food and Drug Administration Regulatory Filing Update for the Opdivo+Yervoy Regimen in Patients with Previously Untreated Advanced Melanoma (180KB)
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Sep.28.2015
Opdivo (nivolumab) Demonstrates Superior Overall Survival in a Phase 3 Trial Compared to Standard of Care in Patients with Previously Treated Advanced Renal Cell Carcinoma (165KB)
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Sep.24.2015
FDA GRANTS PRIORITY REVIEW FOR AMGEN'S SUPPLEMENTAL NEW DRUG APPLICATION FOR EXPANDED LABELING OF KYPROLIS® (CARFILZOMIB) IN RELAPSED MULTIPLE MYELOMA (416KB)
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Sep.17.2015
Bristol-Myers Squibb's Opdivo (nivolumab) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Advanced Renal Cell Carcinoma (157KB)
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Sep.17.2015
ONO Received Two Prizes in “Award of Companies Promoting Gender Equality and Work-Family Balance 2015” Hosted by the Ministry of Health, Labour and Welfare (55.9KB)
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Sep.11.2015
New Cohorts from CheckMate -012 Assess Optimal Dosing of Opdivo+Yervoy in the First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer (236KB)
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Sep.11.2015
Follow-up Data from Two Pivotal Opdivo (nivolumab) Trials Demonstrates Sustained Survival Results in Patients with Previously Treated Squamous Non-Small Cell Lung Cancer (154KB)
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Sep.07.2015
AMGEN SUBMITS MARKETING AUTHORIZATION APPLICATION FOR NOVEL INTRAVENOUS CALCIMIMETIC ETELCALCETIDE (AMG 416) TO THE EUROPEAN MEDICINES AGENCY (16.2KB)
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Sep.03.2015
U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo (nivolumab) in Previously Treated Non-Squamous Non-Small Cell Lung Cancer Patients (164KB)
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Aug.26.2015
ONO Submits Manufacturing and Marketing Approval Application in Japan for “Carfilzomib (ONO-7057)”, a Proteasome Inhibitor, in Relapsed or Refractory Multiple Myeloma (25.7KB)
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Aug.26.2015
AMGEN SUBMITS APPLICATION IN THE US FOR ETELCALCETIDE (AMG 416) FOR THE TREATMENT OF SECONDARY HYPERPARATHYROIDISM (16.4KB)
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Aug.24.2015
ONO obtained approval for additional "dosage and administration" of RIVASTACH® PATCH for the treatment of Alzheimer-Type Dementia -Introduction of a one-step titration that enables more rapid administration of effective dosage- (66.8KB)
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Aug.18.2015
U.S. Food and Drug Administration Extends Action Date for Supplemental Biologics License Application for Opdivo (nivolumab) in Previously Untreated Advanced Melanoma(125KB)
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Aug.04.2015
Announcement on Financial Results for FY2015 1Q
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July.31.2015
ONO submits manufacturing approval partial amendment application for OPDIVO® (generic name: Nivolumab) for treatment of patients with unresectable melanoma in Japan(25.3KB)
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July.28.2015
European Medicines Agency Validates Two Parallel Type II Variation Applications to Extend the Opdivo (nivolumab) Indication in Europe(139KB)
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July.27.2015
FDA Approves Kyprolis® (carfilzomib) For Combination Use In The Treatment Of Patients With Relapsed Multiple Myeloma(90.2KB)
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July.22.2015
European Commission Approves Nivolumab BMS, the First PD-1 Immune Checkpoint Inhibitor in Europe Proven to Extend Survival for Patients with Previously-Treated Advanced Squamous Non-Small Cell Lung Cancer(172KB)
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July.22.2015
CheckMate-025 (global clinical trial), a Pivotal Phase III Opdivo (nivolumab) Renal Cancer Trial Stopped Early(139KB)
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July.21.2015
ONO submits additional indication application for OPDIVO® (generic name: Nivolumab) for the treatment of patients with unresectable, advanced or recurrent non-small cell lung cancer(25.2KB)
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July.13.2015
Notice Concerning Determination of Details of Issuance of Stock Options (Stock Acquisition Rights)(42.3KB)
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Jun.26.2015
Notice Concerning Issuance of Stock Options (Stock Acquisition Rights)(115KB)
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Jun.22.2015
European Commission Approves Bristol-Myers Squibb's Opdivo (nivolumab), the First and Only PD-1 Checkpoint Inhibitor Approved in Europe, for Both First-Line and Previously-Treated Advanced Melanoma Patients(164KB)
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Jun.12.2015
New Post Hoc Analyses of Phase 3b Data Examine Treatment with Orencia® (abatacept) Plus Methotrexate (MTX) in Patients with Early Moderate to Severe Rheumatoid Arthritis (RA) and Markers of Poor Prognosis(287KB)
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Jun.10.2015
TECOS, the Trial Evaluating Cardiovascular Outcomes with JANUVIA® (Sitagliptin), Met Primary Endpoint in Patients with Type 2 Diabetes(180KB)
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Jun.05.2015
U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo+Yervoy Regimen in Patients with Previously Untreated Advanced Melanoma(377KB)
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Jun.05.2015
Phase III CheckMate-067 Trial Demonstrates Superior Progression-Free Survival of Opdivo+Yervoy Regimenor Opdivo Monotherapyvs. Yervoy Monotherapy in Previously Untreated Patients with Advanced Melanoma(188KB)
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Jun.03.2015
Opdivo (nivolumab) First PD-1 Inhibitor to Demonstrate Superior Overall Survival Versus Standard of Care (docetaxel) in Previously-Treated Non-Squamous Non-Small Cell Lung Cancer in Pivotal Phase III Trial(213KB)
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Jun.02.2015
Opdivo (nivolumab) Demonstrates Superior Survival Compared to Standard of Care (docetaxel) for Previously-Treated Squamous Non-Small Cell Lung Cancer in Phase III Trial(156KB)
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Jun.02.2015
Phase I/II Opdivo (nivolumab) Trial Shows Bristol-Myers Squibb’s PD-1 Immune Checkpoint Inhibitor is First to Demonstrate Anti-Tumor Activity In Patients With Hepatocellular Carcinoma(147KB)
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Jun.01.2015
Notice to Convene the 67th Ordinary General Shareholders' Meeting
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May.27.2015
ONO Submits Additional Indication Application for “PROEMEND® for Intravenous Infusion 150mg” for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients Aged 6 Months and Older(25.6KB)
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May.26.2015
Bristol-Myers Squibb Receives Positive CHMP Opinion in the European Union for Nivolumab (Opdivo, Nivolumab BMS) for the Treatment of Advanced Squamous Non-Small Cell Lung Cancer in Previously-Treated Patients(147KB)
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May.12.2015
Announcement on Financial Results for FY2014
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May.12.2015
Position and Policies Concerning the Reduction of the Minimum Investment Unit(25.1KB)
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May.12.2015
Notice Concerning Issuance of Stock Options (Stock Acquisition Rights)
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Apr.30.2015
Bristol-Myers Squibb Company announced about Opdivo (nivolumab).(172KB)
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Apr.27.2015
Bristol-Myers Squibb Receives Positive CHMP Opinion in the European Union for Opdivo (nivolumab) for the Treatment of Advanced Melanoma in Both First-Line and Previously Treated Patients(246KB)
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Apr.22.2015
ONO submits additional indication application for OPDIVO® (generic name: Nivolumab) for the treatment of patients with unresectable, advanced or recurrent non-small cell lung cancer (except non-squamous cell carcinoma)(18.9KB)
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Apr.22.2015
First Randomized Study Evaluating Opdivo (nivolumab)+Yervoy (ipilimumab) Regimen Demonstrates Superior Efficacy Versus Yervoy Alone in Patients with Previously Untreated Advanced Melanoma(184KB)
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Apr.21.2015
CheckMate -057, a Pivotal III Opdivo (nivolumab) Lung Cancer Trial, Stopped Early(146KB)
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Apr.20.2015
(Warning) Be cautious about SNS sites under the name of ‘ONO PHARMACEUTICAL CO., LTD.’
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Apr.06.2015
Announcement on Candidates of Members of the Board of Directors, Corporate Auditors and Corporate Officers(40.3KB)
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Mar.27.2015
Reconstruction Assistance Activities“Operation Slimmer and Healthier” (SUKOYAKARADA DAISAKUSEN) Start from Fukushima Prefecture Exercise Measurement and Recreation with the athletes or Holding a Lifestyle Seminar(358KB)
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Mar.26.2015
ONO Holds The Visiting Lecture about Alzheimer's disease for Junior high school and Senior high school Students(106KB)
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Mar.23.2015
ONO Receives the Approval of the New Drug Application (NDA) for Human Anti-human PD-1 Monoclonal Antibody “OPDIVO®” for the Treatment of Melanoma in South Korea(96.6KB)
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Mar.19.2015
Opicapone significantly improves OFF-time in fluctuating Parkinson's Disease patients as add-on to levodopa(115KB)
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Mar.16.2015
ONO and CCPC enter into an agreement on development and commercialization of Limaprost in Taiwan(18.2KB)
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Mar.05.2015
FDA Approves Opdivo (nivolumab) for the Treatment of Patients with Previously Treated Metastatic Squamous Non-Small Cell Lung Cancer(151KB)
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Mar.03.2015
U.S. Food and Drug Administration Accepts Biologics Licensing Application for Opdivo (nivolumab) for the Treatment of Advanced Squamous Non-Small Cell Lung Cancer(138KB)
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Mar.02.2015
HEAD-TO-HEAD PHASE 3 TRIAL OF KYPROLIS® (CARFILZOMIB) VERSUS VELCADE® (BORTEZOMIB) MET PRIMARY ENDPOINT OF PROGRESSION-FREE SURVIVAL(91.4KB)
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Feb.27.2015
Amgen Announces Results from Phase 3 Clinical Study Comparing AMG 416/ONO-5163 with Cinacalcet Hydrochloride for the Treatment of Patients with Secondary Hyperparathyroidism(11.5KB)
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Feb.16.2015
ONO PHARMACEUTICAL CO., LTD. , and Dako, an Agilent Technologies company announce collaboration on development of PD-L1 companion diagnostic test for investigational cancer drug Opdivo® (nivolumab)(66KB)
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Feb.03.2015
Announcement on Financial Results for FY2014 3Q
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Jan.29.2015
AMGEN SUBMITS APPLICATIONS IN THE US AND EUROPE FOR KYPROLIS® (CARFILZOMIB) FOR THE TREATMENT OF RELAPSED MULTIPLE MYELOMA(115KB)
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Jan.15.2015
CheckMate -017, A Phase 3 Study of Opdivo (Nivolumab) Compared to Docetaxel in Patients with Second-Line Squamous Cell Non-small Cell Lung Cancer, Stopped Early(144KB)
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Jan.15.2015
Outsourcing of Logistics Operation(38.9KB)