News Releases

2016

Dec.27.2016 ONO Submits Supplemental Application of OPDIVO® (Nivolumab) for Unresectable Advanced or Recurrent Gastric Cancer for a Partial Change in Approved Items of Manufacturing and Marketing Approval in Japan (88.8KB)
Dec.22.2016 ONO Enters Into Worldwide OmniAb® Platform License Agreement With Ligand Pharmaceuticals, Inc. (34.6KB)
Dec.21.2016 Revisions of Consolidated Financial Forecasts (86.8KB)
Dec.19.2016 ONO Receives Manufacturing and Marketing Approval in Japan for PARSABIV® (INN: Etelcalcetide Hydrochloride; Development Code: ONO-5163), a Calcimimetic Agent, for the Treatment of Secondary Hyperparathyroidism in Patients on Hemodialysis (36.8KB)
Dec.16.2016 Notice of system (server) maintenance (27.1KB)
Dec.08.2016 Encouraging Survival Observed With Opdivo (nivolumab) Plus Yervoy (ipilimumab) With Longer Follow-up in First-line Advanced Non-small Cell Lung Cancer, in Updated Phase 1b CheckMate -012 Study (188KB)
Dec.07.2016 Opdivo (nivolumab) Alone or Combined With Yervoy (ipilimumab) Shows Encouraging Response and Survival Rates in Recurrent Small Cell Lung Cancer, From Phase 1/2 Study CheckMate -032 (161KB)
Dec.02.2016 OPDIVO® (nivolumab) Intravenous Injection Receives Approval for Supplemental Indication of Relapsed or Refractory Classical Hodgkin Lymphoma in Japan (104KB)
Nov.29.2016 European Commission Approves Bristol-Myers Squibb's Opdivo (nivolumab) for the Treatment of Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma After Autologous Stem Cell Transplant and Treatment With Brentuximab Vedotin (161KB)
Nov.18.2016 Phase 1/2 Data Combining Urelumab with Opdivo (nivolumab) in Hematologic and Solid Tumors Suggest Increased Antitumor Effect in Patients with Melanoma (164KB)
Nov.18.2016 ONO Announces Results from Phase 1/2 and Long-term Clinical Studies of “Etelcalcetide Hydrochloride (ONO-5163)” in Hemodialysis Patients with Secondary Hyperparathyroidism in Japan at ASN Kidney Week 2016 (43.6KB)
Nov.15.2016 Opdivo (nivolumab) and Yervoy (ipilimumab) Regimen Shows Promising Efficacy and Safety in Previously Treated Patients With Advanced Form of Bladder Cancer (159KB)
Nov.14.2016 Bristol-Myers Squibb's Opdivo® (nivolumab) is the First Immuno-Oncology Treatment to Receive FDA Approval Based on Overall Survival in Head and Neck Cancer (192KB)
Nov.14.2016 Amgen Receives Marketing Authorization Approval from European Commission for Parsabiv™ (Etelcalcetide) to Treat Patients with Secondary Hyperparathyroidism (31.8KB)
Nov.10.2016 Opdivo® (nivolumab) Intravenous Infusion Demonstrates a Significant Extension in Overall Survival Versus Placebo in Patients with Unresectable Advanced or Recurrent Gastric Cancer Refractory to or Intolerant of Standard Therapy in Phase III Clinical Study (ONO-4538-12 Study) (65.5KB)
Nov.07.2016 Announcement on Financial Results for FY2016 2Q
Oct.26.2016 New Results Presented for Opdivo (nivolumab) Demonstrated Encouraging Response Rate in an Expanded Population of Heavily Pre-Treated Classical Hodgkin Lymphoma Patients (177KB)
Oct.26.2016 U.S. Food and Drug Administration Accepts for Priority Review the Supplemental Biologics License Application for Opdivo (nivolumab) in Previously Treated Patients With Advanced Form of Bladder Cancer (153KB)
Oct.24.2016 Filing of Patent Infringement Lawsuit against MSD K.K. (81.5KB)
Oct.18.2016 Bristol-Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) for the Treatment of Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma After Autologous Stem Cell Transplant and Treatment With Brentuximab Vedotin (144KB)
Oct.11.2016 Opdivo (nivolumab) Shows Durable Response in Longest Follow-up for a PD-1 Inhibitor in Previously Treated Advanced Non-Small Cell Lung Cancer (149KB)
Oct.11.2016 Updated Results Presented for the Opdivo (nivolumab) and Yervoy (ipilimumab) Combination in Metastatic Renal Cell Carcinoma From Phase 1 Study (151KB)
Oct.11.2016 Bristol-Myers Squibb Presents Results From CheckMate -026, a Phase 3 Study of Opdivo (nivolumab) Monotherapy Versus Chemotherapy as First-Line Therapy in a Broad PD-L1 Positive Population With Advanced Lung Cancer (165KB)
Oct.11.2016 Opdivo (nivolumab) Stabilized Patient-reported Outcomes in Patients With Previously Treated Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck in Pivotal Phase 3 CheckMate -141 Study (166KB)
Oct.11.2016 Results From CheckMate-275 Validate Further Study of Opdivo (nivolumab) in Patients With Advanced Form of Bladder Cancer (167KB)
Sep.28.2016 Amgen Announces Top-line Results from Phase III Kyprolis® (Carfilzomib) CLARION Study in Newly Diagnosed Multiple Myeloma Patients (57.2KB)
Sep.21.2016 European Medicines Agency Validates Bristol-Myers Squibb's Type II Variation Application for Opdivo (nivolumab) in Advanced Form of Bladder Cancer (189KB)
Sep.14.2016 European Commission Approves Bristol-Myers Squibb's ORENCIA® (abatacept) for the Treatment of Highly Active and Progressive Disease in Adult Patients with Rheumatoid Arthritis Not Previously Treated with Methotrexate (133KB)
Sep.07.2016 ONO Receives Approval for OPDIVO® (nivolumab) Intravenous Infusion for Treatment of Unresectable or Metastatic Renal Cell Carcinoma in Japan as Part of Partial Change in Approved Items of Manufacturing and Marketing Authorization (53.2KB)
Sep.07.2016 ONO Launches KYPROLIS® for Intravenous Injection 10 mg and 40 mg Proteasome Inhibitor (80.9KB)
Sep.07.2016 ONO Submits Supplemental New Drug Application in Japan for “KYPROLIS® for Intravenous Injection 10 mg and 40 mg", a Proteasome Inhibitor, for Relapsed or Refractory Multiple Myeloma (36.8KB)
Sep.05.2016 Announcement on posting of Corporate Report 2016
Aug.09.2016 Influence of Cliical Results from CheckMate-026, a Phase III Study of Opdivo® (nivolumab) in Treatment-Naïve Patients with Advanced Non-Small Cell Lung Cancer (82.1KB)
Aug.08.2016 Bristol-Myers Squibb Announces Top-Line Results from CheckMate-026, a Phase 3 Study of Opdivo (nivolumab) in Treatment-Naïve Patients with Advanced Non-Small Cell Lung Cancer (294KB)
Aug.02.2016 Announcement on Financial Results for FY2016 1Q
Jul.27.2016 ONO Submits Supplemental Application of OPDIVO® (Nivolumab) for Recurrent or Metastatic Head and Neck Cancer for a Partial Change in Approved Items of Manufacturing and Marketing Approval in Japan (49.5KB)
Jul.19.2016 Bristol-Myers Squibb Announces Regulatory Updates for Opdivo (nivolumab) in Previously Treated Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (207KB)
Jul.14.2016 Notice Concerning Determination of Details of Issuance of Stock Options (Stock Acquisition Rights) (20.1KB)
Jul.12.2016 Amgen Receives Approval for Kyprolis® (Carfilzomib) For Expanded Indication for the Treatment of Relapsed Multiple Myeloma (49.5KB)
Jul.11.2016 ONO enters into license agreement with Celyad for its allogeneic CAR T-cell therapy (NKR-2) (49.8KB)
Jul.06.2016 European Commission approves ONGENTYS® (opicapone) a novel treatment for Parkinson's disease patients with motor fluctuations (352KB)
Jul.04.2016 ONO Receives Manufacturing and Marketing Approval in Japan for KYPROLIS® (INN: Carfilzomib; development code: ONO-7057), a Proteasome Inhibitor, in Relapsed or Refractory Multiple Myeloma (49.8KB)
Jun.29.2016 Notice of Resolutions Passed at The 68th Ordinary General Shareholders' Meeting
Jun.29.2016 Notice Concerning Issuance of Stock Options (Stock Acquisition Rights) (188KB)
Jun.28.2016 Opdivo® (nivolumab) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Advanced Form of Bladder Cancer (203KB)
Jun.15.2016 New Data on Opdivo (nivolumab) Indicate Benefit in Heavily Pre-Treated Classical Hodgkin Lymphoma Patients in Phase 2, Single-Arm Pivotal Trial (167KB)
Jun.09.2016 First Presentation of Phase 2 CheckMate-142 Study Evaluating Opdivo® (nivolumab) Alone or in Combination with Yervoy® (ipilimumab) Demonstrates Encouraging Clinical Activity in MSI-High Metastatic Colorectal Cancer (186KB)
Jun.08.2016 Opdivo® (nivolumab) and Yervoy® (ipilimumab) Combination Regimen Shows Clinically Meaningful Responses in First-Line Advanced Non-Small Cell Lung Cancer In Updated Phase 1b CheckMate -012 (221KB)
Jun.07.2016 Long-Term Data from Two Trials Evaluating the Opdivo® (nivolumab) and Yervoy® (ipilimumab) Regimen in Advanced Melanoma Continues to Validate Bristol-Myers Squibb's Immuno-Oncology Combination Approach (191KB)
Jun.06.2016 Long-Term Survival and Improvement in Quality of Life Observed with Opdivo® (nivolumab) in Advanced Renal Cell Carcinoma Patients Based on New Data Presented at the 2016 ASCO Annual Meeting (169KB)
Jun.06.2016 Promising Response Rates with Opdivo® (nivolumab) Observed In Advanced Form of Bladder Cancer From Phase 1/2 Study CheckMate-032 (167KB)
Jun.03.2016 Amgen Receives Positive CHMP Opinion to Extend Indication of Kyprolis® (Carfilzomib) for the Treatment of Relapsed Multiple Myeloma (49.6KB)
Jun.01.2016 Notice to Convene the 68th Ordinary General Shareholders' Meeting
May.25.2016 Launch of Orencia® SC 125 mg Auto-injector 1 mL for Treatment of Rheumatoid Arthritis (98.6KB)
May.24.2016 Two-Year Overall Survival Data from Two Pivotal Opdivo® (nivolumab) Trials Demonstrate Sustained Benefit In Patients with Advanced Non-Small Cell Lung Cancer (196KB)
May.24.2016 ONO Announces Results from Phase 1/2 and Phase 3 Clinical Studies of gEtelcalcetide Hydrochloride (ONO-5163)h in Hemodialysis Patients with Secondary Hyperparathyroidism in Japan at ERA-EDTA Congress (35.8KB)
May.20.2016 Opdivo® (nivolumab) Granted First Approval of a PD-1 Inhibitor in Hematology for the Treatment of Classical Hodgkin Lymphoma Patients Who Have Relapsed or Progressed After Auto-HSCT and Post-transplantation Brentuximab Vedotin by the FDA (156KB)
May.20.2016 European Commission Approves the First and Only Immuno-Oncology Combination, Opdivo® (nivolumab) + Yervoy® (ipilimumab) Regimen, for Treatment of Advanced Melanoma (177KB)
May.17.2016 ONO Enters an Agreement with IDAC Theranostics relating to Exclusive Evaluation and License Negotiation on IT1208, anti-CD4 antibody (75.3KB)
May.11.2016 Announcement on Financial Results for FY2015
May.09.2016 ONO PHARMA TAIWAN Receives Approval of OPDIVO® (Nivolumab) for New Drug Application for Unresectable or Metastatic Melanoma and Metastatic Squamous Non-Small Cell Lung Cancer in Taiwan (28.7KB)
May.09.2016 Bristol-Myers Squibb's Opdivo® (nivolumab) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Previously Treated Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (138KB)
May.06.2016 Revision of Consolidated Financial Forecasts (37.0KB)
May.06.2016 Notice regarding Differences between Non-consolidated Results for the Fiscal year Ended March 31, 2016 and those for the Previous Fiscal Year (55.3KB)
Apr.28.2016 Announcement on Candidates of Members of the Board of Directors, Audit & Supervisory Board Members and Corporate Officers (66.2KB)
Apr.22.2016 First Presentation of Two-Year Overall Survival Data for Opdivo® (nivolumab) in Combination with Yervoy® (ipilimumab) Showed Superior Efficacy Versus Yervoy Alone in Advanced Melanoma (180KB)
Apr.21.2016 First Presentation of Overall Survival Data for Opdivo® (nivolumab) Shows Significant Survival Benefit at One-Year Versus Investigator's Choice in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (229KB)
Apr.19.2016 Support for Relief Efforts to the Kumamoto Earthquake (25.5KB)
Apr.19.2016 U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb's Supplemental Biologics License Application for Opdivo® (nivolumab) for the Treatment of Classical Hodgkin Lymphoma Patients (147KB)
Apr.13.2016 European Commission Approves Expanded Use of Opdivo® (nivolumab) to Include Previously Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer (131KB)
Apr.11.2016 ONO Announces Sales Results of OPDIVO® (Nivolumab), Antineoplastic Agent for Fiscal Year 2015 and its Sales Forecasts for Fiscal Year 2016 (33.8KB)
Apr.08.2016 European Commission Approves Bristol-Myers Squibb's Opdivo® (nivolumab) for Previously Treated Advanced Renal Cell Carcinoma (188KB)
Apr.06.2016 Bristol-Myers Squibb Receives Positive CHMP Opinion for Opdivo® (nivolumab) in Combination with Yervoy® (ipilimumab) for Treatment of Advanced Melanoma (139KB)
Apr.04.2016 ONO PHARMA KOREA Receives Approval for OPDIVO® (Nivolumab) for Expanded Application of Unresectable or Metastatic Melanoma and Additional Indication of Locally Advanced or Metastatic Non-small Cell Lung Cancer Refractory to Existing Chemotherapy in South Korea (90.2KB)
Apr.01.2016 European Medicines Agency Validates Bristol-Myers Squibb's Application for Opdivo® (nivolumab) for the Treatment of Classical Hodgkin Lymphoma Patients (156KB)
Mar.30.2016 ONO Enters Licensing Agreement with Santen for ONO-9054, FP/EP3 Dual Receptor Agonist (33.5KB)
Mar.18.2016 ONO Submits Supplemental Application of OPDIVO® (Nivolumab) for Additional Indication of Relapsed or Refractory Hodgkinfs Lymphoma (82.7KB)
Mar.18.2016 ONO Receives Approval for PROEMEND® for Intravenous Infusion 150 mg for Treatment of Chemotherapy-Induced Nausea and Vomiting for a Partial Change in Approved Items for Additional Application to Pediatric Patients (50.6KB)
Mar.11.2016 Reconstruction Assistance Activities gOperation Slimmer and Healthierh (SUKOYAKARADA DAISAKUSEN) Held in Miyagi Prefecture - Recreation with the Athletes or Holding a Lifestyle Seminar - (655KB)
Mar.04.2016 ONO Announces Stock Split and Partial Amendment to the Articles of Incorporation (27.8KB)
Mar.02.2016 Bristol-Myers Squibb Receives Two Positive CHMP Opinions for Opdivo® (nivolumab) for Patients with Previously Treated Advanced Non-Squamous Non-Small Cell Lung Cancer and Renal Cell Carcinoma (127KB)
Mar.01.2016 Completion of the new Research Building (The Third Building) in the Minase Research Institute (238KB)
Feb.29.2016 ONO Receives Approval for OPDIVO® (Nivolumab) for a Partial Change in Approved Items for Treatment of Unresectable Melanoma in Japan (49.8KB)
Feb.26.2016 Manufacturing and Marketing Approval of Orencia®SC 125mg Auto-injector 1mL for Rheumatoid Arthritis Treatment (186KB)
Feb.12.2016 Support for Relief Efforts to Southern Taiwan Earthquake (21.8KB)
Feb.02.2016 CheckMate -141, a Pivotal Phase 3 Opdivo (nivolumab) Head and Neck Cancer Trial, Stopped Early (144KB)
Feb.02.2016 Announcement on Financial Results for FY2015 3Q
Feb.02.2016 Revision of Consolidated Financial Forecasts (33.9KB)
Jan.28.2016 Bristol-Myers Squibb's Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status (197KB)
Jan.22.2016 FDA Approves NEW Kyprolis® (Carfilzomib) COMBINATION THERAPY for the treatment of patients with Relapsed Or Refractory multiple myeloma (25.7KB)
Jan.14.2016 ONO Submits Manufacturing and Marketing Approval Application in Japan for “Etelcalcetide Hydrochloride” (ONO-5163), a Calcimimetic Agent, for Secondary Hyperparathyroidism in Patients on Hemodialysis (25.2KB)