News Releases

2015

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)
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)
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)
Dec.09.2015 Amgen Submits Application In Europe To Expand Indication Of Kyprolis® (carfilzomib) For The Treatment Of Relapsed Multiple Myeloma (29.4KB)
Dec.02.2015 Bristol-Myers Squibb Announces Regulatory Update for Opdivo (nivolumab) in Advanced Melanoma (149KB)
Dec.01.2015 HELSINN ANNOUNCES EUROPEAN MEDICINES AGENCY ACCEPTANCE OF MARKETING AUTHORIZATION APPLICATION FOR ANAMORELIN HCL (37.8KB)
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)
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)
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)
Nov.24.2015 European Commission Approves Kyprolis® (carfilzomib) For Combination Use In The Treatment Of Patients With Relapsed Multiple Myeloma (21.4KB)
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)
Nov.06.2015 European Medicines Agency Validates Bristol-Myers Squibbfs Type II Variation Application for Opdivo (nivolumab) in Previously Treated Advanced Renal Cell Carcinoma (129KB)
Nov.04.2015 Announcement on Financial Results for FY2015 2Q
Oct.30.2015 Bristol-Myers Squibb's Opdivo (nivolumab) Recipient of Prix Galien USA 2015 Award for Best Biotechnology Product (147KB)
Oct.26.2015 Revisions of Consolidated Financial Forecasts (25.8KB)
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)
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)
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)
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)
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)
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)
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)
Sep.17.2015 ONO Received Two Prizes in gAward of Companies Promoting Gender Equality and Work-Family Balance 2015h Hosted by the Ministry of Health, Labour and Welfare (55.9KB)
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)
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)
Sep.07.2015 AMGEN SUBMITS MARKETING AUTHORIZATION APPLICATION FOR NOVEL INTRAVENOUS CALCIMIMETIC ETELCALCETIDE (AMG 416) TO THE EUROPEAN MEDICINES AGENCY (16.2KB)
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)
Aug.26.2015 ONO Submits Manufacturing and Marketing Approval Application in Japan for gCarfilzomib (ONO-7057)h, a Proteasome Inhibitor, in Relapsed or Refractory Multiple Myeloma (25.7KB)
Aug.26.2015 AMGEN SUBMITS APPLICATION IN THE US FOR ETELCALCETIDE (AMG 416) FOR THE TREATMENT OF SECONDARY HYPERPARATHYROIDISM (16.4KB)
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)
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)
Aug.04.2015 Announcement on Financial Results for FY2015 1Q
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)
July.28.2015 European Medicines Agency Validates Two Parallel Type II Variation Applications to Extend the Opdivo (nivolumab) Indication in Europe(139KB)
July.27.2015 FDA Approves Kyprolis® (carfilzomib) For Combination Use In The Treatment Of Patients With Relapsed Multiple Myeloma(90.2KB)
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)
July.22.2015 CheckMate-025 (global clinical trial), a Pivotal Phase III Opdivo (nivolumab) Renal Cancer Trial Stopped Early(139KB)
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)
July.13.2015 Notice Concerning Determination of Details of Issuance of Stock Options (Stock Acquisition Rights)(42.3KB)
Jun.26.2015 Notice Concerning Issuance of Stock Options (Stock Acquisition Rights)(115KB)
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)
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)
Jun.10.2015 TECOS, the Trial Evaluating Cardiovascular Outcomes with JANUVIA® (Sitagliptin), Met Primary Endpoint in Patients with Type 2 Diabetes(180KB)
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)
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)
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)
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)
Jun.02.2015 Phase I/II Opdivo (nivolumab) Trial Shows Bristol-Myers Squibbfs PD-1 Immune Checkpoint Inhibitor is First to Demonstrate Anti-Tumor Activity In Patients With Hepatocellular Carcinoma(147KB)
Jun.01.2015 Notice to Convene the 67th Ordinary General Shareholders' Meeting
May.27.2015 ONO Submits Additional Indication Application for gPROEMEND® for Intravenous Infusion 150mgh for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients Aged 6 Months and Older(25.6KB)
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)
May.12.2015 Announcement on Financial Results for FY2014
May.12.2015 Position and Policies Concerning the Reduction of the Minimum Investment Unit(25.1KB)
May.12.2015 Notice Concerning Issuance of Stock Options (Stock Acquisition Rights)
Apr.30.2015 Bristol-Myers Squibb Company announced about Opdivo (nivolumab).(172KB)
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)
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)
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)
Apr.21.2015 CheckMate -057, a Pivotal III Opdivo (nivolumab) Lung Cancer Trial, Stopped Early(146KB)
Apr.20.2015 (Warning) Be cautious about SNS sites under the name of eONO PHARMACEUTICAL CO., LTD.f
Apr.06.2015 Announcement on Candidates of Members of the Board of Directors, Corporate Auditors and Corporate Officers(40.3KB)
Mar.27.2015 Reconstruction Assistance ActivitiesgOperation Slimmer and Healthierh (SUKOYAKARADA DAISAKUSEN) Start from Fukushima Prefecture Exercise Measurement and Recreation with the athletes or Holding a Lifestyle Seminar(358KB)
Mar.26.2015 ONO Holds The Visiting Lecture about Alzheimer's disease for Junior high school and Senior high school Students(106KB)
Mar.23.2015 ONO Receives the Approval of the New Drug Application (NDA) for Human Anti-human PD-1 Monoclonal Antibody gOPDIVO®h for the Treatment of Melanoma in South Korea(96.6KB)
Mar.19.2015 Opicapone significantly improves OFF-time in fluctuating Parkinson's Disease patients as add-on to levodopa(115KB)
Mar.16.2015 ONO and CCPC enter into an agreement on development and commercialization of Limaprost in Taiwan(18.2KB)
Mar.05.2015 FDA Approves Opdivo (nivolumab) for the Treatment of Patients with Previously Treated Metastatic Squamous Non-Small Cell Lung Cancer(151KB)
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)
Mar.02.2015 HEAD-TO-HEAD PHASE 3 TRIAL OF KYPROLIS® (CARFILZOMIB) VERSUS VELCADE® (BORTEZOMIB) MET PRIMARY ENDPOINT OF PROGRESSION-FREE SURVIVAL(91.4KB)
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)
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)
Feb.03.2015 Announcement on Financial Results for FY2014 3Q
Jan.29.2015 AMGEN SUBMITS APPLICATIONS IN THE US AND EUROPE FOR KYPROLIS® (CARFILZOMIB) FOR THE TREATMENT OF RELAPSED MULTIPLE MYELOMA(115KB)
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)
Jan.15.2015 Outsourcing of Logistics Operation(38.9KB)