News Releases

2017

R&D
Dec.22.2017
ONO Submits Supplemental Application of Opdivo® (Nivolumab) for Indication of Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma in Japan for a Partial Change in Approved Items of Manufacturing and Marketing Approval (72.4KB)
R&D
Dec.22.2017
ONO Submit Supplemental Application of Opdivo® (Nivolumab) for Expanded Use of the Adjuvant Treatment of Melanoma in Japan for a Partial Change in Approved Items of Manufacturing and Marketing Approval (73.7KB)
R&D
Dec.22.2017
ONO Submits Supplemental Application of Opdivo® (Nivolumab) for Dosage and Administration of Single Dosing Regimen in Japan for a Partial Change in Approved Items of Manufacturing and Marketing Approval (49.6KB)
R&D
Dec.21.2017
Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease (44.7KB)
Licensing
Dec.19.2017
ONO enters into Collaboration Agreement with Schrödinger Inc. (41.2KB)
R&D
Dec.18.2017
U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb's Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Intermediate- and Poor-Risk Patients with Advanced Renal Cell Carcinoma and Grants Priority Review (62.3KB)
Licensing
Dec.14.2017
ONO Enters into License Agreement with Bristol-Myers Squibb for Prostaglandin E2 Receptor Antagonists relating to Immuno-Oncology Programs (44.1KB)
Licensing
Dec.12.2017
Ono Enters into Collaboration Agreement with Cyclenium Pharma, Inc. (33.8KB)
R&D
Dec.06.2017
CheckMate -078, a Pivotal, Multinational Phase 3 Opdivo (nivolumab) Lung Cancer Trial with Predominantly Chinese Patients, Stopped Early for Demonstrating Superior Overall Survival (44.6KB)
Corporate
Dec.01.2017
Ono Announces Participation in United Nations Global Compact (102KB)
R&D
Nov.29.2017
European Medicines Agency Validates Bristol-Myers Squibb's Type II Variation Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) in Intermediate- and Poor- Risk Patients with Advanced Renal Cell Carcinoma (43.9KB)
R&D
Nov.16.2017
Encouraging Response Observed with Opdivo (nivolumab) Plus Investigational IDO1 Inhibitor, BMS-986205, in Heavily Pre-Treated Patients with Advanced Cancers in Phase 1/2a Study CA017-003 (68.3KB)
R&D
Nov.10.2017
Opdivo Plus Yervoy Combination Delivered Overall Survival Benefit Across PD-L1 Expression Levels in Intermediate- and Poor-Risk Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (76.3KB)
Licensing
Nov.09.2017
ONO announces collaboration with Neurimmune in Neurodegenerative Diseases Field (59.7KB)
R&D
Nov.08.2017
Opdivo (nivolumab) Demonstrates Superior Three-Year Survival Benefit for Patients with Previously Treated Advanced Renal Cell Carcinoma (RCC) (44.1KB)
R&D
Nov.07.2017
Opdivo® (Nivolumab) Intravenous Infusion Approved in Taiwan for Expanded Use in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated with Platinum-based Therapy (65.0KB)
R&D
Oct.31.2017
European Medicines Agency Validates Bristol-Myers Squibb’s Type II Variation Application for Opdivo (nivolumab) for Treatment of Patients with Resected High-Risk Advanced Melanoma (44.4KB)
Management / Finance
Oct.31.2017
Notice Regarding Completion of Cancellation of Treasury Shares (87.3KB)
R&D
Oct.30.2017
Opdivo® (Nivolumab) Intravenous Infusion Approved in Taiwan for Additional Indications of Relapsed or Progressed Classical Hodgkin Lymphoma, Locally Advanced Unresectable or Metastatic Urothelial Carcinoma, and Unresectable or Metastatic Melanoma (66.9KB)
Management / Finance
Oct.26.2017
Revisions of Consolidated Financial Forecasts (77.5KB)
R&D
Oct.25.2017
Phase 3 A.R.R.O.W. Study of Once-Weekly Kyprolis® (Carfilzomib) Regimen Meets Primary Endpoint of Progression-Free Survival in Relapsed and Refractory Multiple Myeloma Patients (34.9KB)
R&D
Oct.17.2017
Opdivo Alone or Combined with Yervoy Shows Encouraging Response and Survival Rates in Recurrent Small Cell Lung Cancer Patients with High Tumor Mutation Burden, in Exploratory Analysis from Phase 1/2 Study CheckMate -032 (44.3KB)
R&D
Oct.17.2017
U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb's Application for Opdivo (nivolumab) in Patients with Resected High-Risk Advanced Melanoma and Grants Priority Review (44.3KB)
Licensing
Oct.12.2017
Ono Enters into Exclusive License Agreement with Karyopharm to Develop and Commercialize Selinexor and KPT-8602, XPO1 Inhibitors (77.9KB)
Management / Finance
Oct.02.2017
Notice of Completion of Acquisition of Own Shares (90.8KB)
R&D
Sep.29.2017
ONO and BMSKK Submit Supplemental Application for Opdivo® (Nivolumab) and Yervoy® (Ipilimumab) Combination Therapy for Unresctable Melanoma in Japan (51.7KB)
R&D
Sep.28.2017
Ono and Seikagaku Announce Initiation of a Late-Stage Phase II Clinical Trial of SI-613 for Treatment of Enthesopathy (98.6KB)
R&D
Sep.27.2017
Bristol-Myers Squibb's Opdivo® (nivolumab) Receives FDA Approval for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib (45.0KB)
R&D
Sep.22.2017
ONO Receives Approval for OPDIVO® (Nivolumab) Intravenous Infusion for Treatment of Unresectable Advanced or Recurrent Gastric Cancer which Has Progressed after Chemotherapy as a Partial Change in Approved Items of Manufacturing and Marketing Approval in Japan (83.1KB)
R&D
Sep.20.2017
Opdivo® (Nivolumab) Intravenous Infusion Approved for Expanded Use in Advanced Non-squamous Non-small Cell Lung Cancer which Has Been Previously Treated with Platinum-based Therapy in Taiwan (65.2KB)
R&D
Sep.19.2017
Opdivo® (Nivolumab) Intravenous Infusion Approved for Expanded Use in Unresectable or Metastatic Melanoma in South Korea (40.7KB)
R&D
Sep.14.2017
Array BioPharma Announces FDA Acceptance for Review of Binimetinib and Encorafenib New Drug Applications for Patients with Advanced BRAF-mutant Melanoma (31.3KB)
R&D
Sep.13.2017
Phase 3 BEACON CRC Safety Lead-In Results in BRAF-Mutant Colorectal Cancer Presented at European Society for Medical Oncology Congress (31.1KB)
R&D
Sep.13.2017
Phase 3 COLUMBUS Part 2 Results in BRAF-Mutant Melanoma Presented at European Society for Medical Oncology Congress (30.9KB)
R&D
Sep.12.2017
Opdivo Plus Yervoy Combination Demonstrated Superior Overall Survival and Showed Durable Responses in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma in Phase 3 CheckMate -214 Trial (45.6KB)
R&D
Sep.11.2017
Two Pivotal Opdivo (nivolumab) Trials Show Three-Year Survival Benefit in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer (64.6KB)
R&D
Sep.11.2017
Opdivo (nivolumab) Demonstrates Superior Recurrence-Free Survival Versus Yervoy (ipilimumab) for Patients with Resected High-Risk Melanoma in Phase 3 CheckMate -238 Study (43.6KB)
R&D
Sep.08.2017
CheckMate -214 Study Evaluating Opdivo in Combination with Yervoy Stopped Early for Demonstrating Overall Survival Benefit in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (44.3KB)
Licensing
Sep.08.2017
CONCLUSION OF DEVELOPMENT COLLABORATION AGREEMENT FOR OPDIVO® (NIVOLUMAB) AND LENVIMA® (LENVATINIB MESYLATE) COMBINATION THERAPY FOR TREATMENT OF HEPATOCELLULAR CARCINOMA (124KB)
R&D
Sep.01.2017
Long-Term Analysis of Phase 3 Head-To-Head Study Confirms KYPROLIS® (Carfilzomib) Regimen Extends Overall Survival in Patients with Relapsed Multiple Myeloma (35.4KB)
Management / Finance
Sep.01.2017
Ono Pharmaceutical Announces Status of Acquisition of Own Shares (150KB)
Licensing
Sep.01.2017
Ono and Seikagaku Reach a Definitive Agreement Related to Co-development and Marketing Collaboration on SI-613 for the Treatment of Osteoarthritis in Japan (48.1KB)
R&D
Aug.30.2017
Opdivo® (Nivolumab) Intravenous Infusion Approved for Supplemental Indications of Advanced Renal Cell Carcinoma, Relapsed or Progressed Classical Hodgkin Lymphoma, Recurrent or Metastatic Head and Neck, Locally Advanced or Metastatic Urothelial Carcinoma, and Unresectable or Metastatic Melanoma in Combination with Ipilimumab in South Korea (66.6KB)
R&D
Aug.16.2017
Opdivo® (Nivolumab) Intravenous Infusion Approved for Supplemental Indication of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck with Disease Progression on or after Platinum-based Therapy in Taiwan (74.5KB)
R&D
Aug.16.2017
Bristol-Myers Squibb Announces Topline Results from CheckMate -214, a Phase 3 Study of Opdivo in Combination with Yervoy in Intermediate and Poor-Risk Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (45.4KB)
R&D
Aug.03.2017
Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in MSI-H or dMMR Metastatic Colorectal Cancer That Has Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin, and Irinotecan (46.1KB)
Management / Finance
Aug.01.2017
Ono Pharmaceutical Announces Status of Acquisition of Own Shares (150KB)
CSR
Jul.18.2017
Support for Relief Efforts to the Northern Kyushu Heavy Rain (34.4KB)
Management / Finance
Jul.14.2017
Notice Concerning Determination of Details of Issuance of Stock Options (Stock Acquisition Rights) (92.6KB)
R&D
Jul.13.2017
Second Phase III Study Shows Kyprolis® (Carfilzomib) Regimen Significantly Improves Overall Survival in Patients with Relapsed Multiple Myeloma (35.3KB)
R&D
Jul.06.2017
Phase 3 Study Evaluating the Safety and Efficacy of Adjuvant Opdivo in Resected High-Risk Melanoma Patients Meets Primary Endpoint (43.8KB)
R&D
Jul.06.2017
Array BioPharma Submits New Drug Applications to FDA for Binimetinib and Encorafenib in Advanced Melanoma (30.8KB)
Management / Finance
Jul.03.2017
Ono Pharmaceutical Announces Status of Acquisition of Own Shares (150KB)
Management / Finance
Jun.29.2017
Notice Concerning Issuance of Stock Options (Stock Acquisition Rights) (212KB)
R&D
Jun.19.2017
Extended Follow-Up Data Evaluating Opdivo (nivolumab) Shows Durable Response in Adult Patients with Relapsed or Progressed Classical Hodgkin Lymphoma (137KB)
Management / Finance
Jun.13.2017
Announcement on Acquisition and Retirement of Own Shares (93.7KB)
R&D
Jun.05.2017
European Commission Approves Bristol-Myers Squibb's Opdivo (nivolumab) for Previously Treated Locally Advanced Unresectable or Metastatic Urothelial Carcinoma in Adults After Failure of Prior Platinum-Containing Therapy (186KB)
R&D
Jun.05.2017
First Presentation of Efficacy Data from CheckMate -204 Evaluating the Combination of Opdivo (nivolumab) and Yervoy (ipilimumab) Demonstrates Anti-tumor Activity in Advanced Melanoma Patients with Brain Metastases (168KB)
R&D
Jun.05.2017
Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Demonstrated Promising Activity in Previously Treated Patients with dMMR or MSI-H Metastatic Colorectal Cancer in Phase 2 CheckMate -142 Study (182KB)
R&D
Jun.05.2017
Anti-LAG-3 (BMS-986016) in Combination with Opdivo (nivolumab) Showed Activity in Patients with Melanoma Who Were Relapsed or Refractory to Anti-PD-1/PD-L1 Therapy (175KB)
R&D
Jun.05.2017
Opdivo (nivolumab) Data in Patients with Advanced Cervical, Vaginal and Vulvar Cancers from Phase 1/2 CheckMate -358 Presented at ASCO (181KB)
Licensing
May.31.2017
ONO Concludes a License Agreement with Array Biopharma related to Binimetinib, a MEK inhibitor and Encorafenib, a BRAF inhibitor (59.8KB)
R&D
May.25.2017
U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb's Application for Opdivo (nivolumab) in Previously Treated Hepatocellular Carcinoma (154KB)
R&D
May.18.2017
ONO Receives Supplemental Manufacturing and Marketing Approval of KYPROLIS® for Intravenous Injection 10 mg and 40 mg, a Proteasome Inhibitor, in Relapsed or Refractory Multiple Myeloma (66.3KB)
Licensing
May.12.2017
Seikagaku and Ono Reach a Basic Agreement Related to Co-development and Marketing Collaboration on SI-613 for the Treatment of Osteoarthritis in Japan (47.8KB)
Management / Finance
May.11.2017
Notice regarding Differences between Non-consolidated Results for the Fiscal year Ended March 31, 2017 and those for the Previous Fiscal Year (56.5KB)
R&D
May.08.2017
European Commission Approves Bristol-Myers Squibb’s Opdivo (nivolumab) for Squamous Cell Cancer of the Head and Neck in Adults Progressing On or After Platinum-based Therapy (192KB)
Corporate
Apr.28.2017
Announcement on Candidates of Members of the Board of Directors and Corporate Officers (42.5KB)
R&D
Apr.28.2017
OPDIVO® (Nivolumab) Intravenous Infusion Approved for Supplemental Indication of Advanced Renal Cell Carcinoma Who Have Received Prior Anti-angiogenic Therapy in Taiwan (49.8KB)
R&D
Apr.24.2017
Opdivo® (nivolumab) Designated for the Treatment of Biliary Tract Cancer Under the SAKIGAKE Designation System (42.8KB)
R&D
Apr.24.2017
Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) for the Treatment of Patients with Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer (149KB)
CSR
Apr.20.2017
Reconstruction Assistance Activities “Operation Slimmer and Healthier” (SUKOYAKARADA DAISAKUSEN) Held in Iwate Prefecture - Recreation with the Athletes or Holding a Lifestyle Seminar - (529KB)
R&D
Apr.06.2017
U.S. Food and Drug Administration Accepts for Priority Review Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Previously Treated dMMR or MSI-H Metastatic Colorectal Cancer (151KB)
R&D
Apr.05.2017
Five-Year Survival Observed With Opdivo (nivolumab) in Patients With Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC), in Phase 1 Study CA209-003 (152KB)
R&D
Apr.05.2017
Bristol-Myers Squibb Announces Results from CheckMate -143, a Phase 3 Study of Opdivo (nivolumab) in Patients with Glioblastoma Multiforme (125KB)
R&D
Apr.05.2017
Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) and Opdivo Monotherapy Significantly Improved Overall Survival Versus Yervoy Alone in Patients with Previously Untreated Advanced Melanoma (160KB)
R&D
Mar.30.2017
Supplemental Application of Orencia® (Abatacept) Intravenous Injection 250 mg a Selective T-cell Co-stimulation Modulator for Treatment of Juvenile Idiopathic Arthritis for a Partial Change in Approved Items of Manufacturing and Marketing Approval (80.9KB)
Licensing
Mar.28.2017
ONO Enters into a Research and Option Agreement with Numab (42.6KB)
R&D
Mar.28.2017
Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Opdivo (nivolumab) for the Treatment of Squamous Cell Cancer of the Head and Neck in Adults Progressing on or After Platinum-based Therapy (132KB)
R&D
Mar.24.2017
ONO Receives Approval for OPDIVO® (Nivolumab) Intravenous Infusion for Treatment of Recurrent or Metastatic Head and Neck Cancer as a Partial Change in Approved Items of Manufacturing and Marketing Approval in Japan (63.8KB)
Licensing
Mar.21.2017
Ono Enters into Collaboration Agreement with X-Chem, Inc. (53.8KB)
R&D
Mar.02.2017
Phase III Head-to-Head Trial Showed KYPROLIS® (Carfilzomib) Significantly Improved Overall Survival Compared to Velcade® (Bortezomib) in Relapsed or Refractory Multiple Myeloma Patients (33.8KB)
Products
Feb.15.2017
Launch of PARSABIV® Intravenous Injection for Dialysis (Generic Name: Etelcalcetide Hydrochloride), a Calcimimetic Agent, for Treatment of Secondary Hyperparathyroidism in Patients on Hemodialysis (65.8KB)
R&D
Feb.08.2017
U.S. Food and Drug Administration Approves Parsabiv™ (Etelcalcetide) to Treat Secondary Hyperparathyroidism in Adult Patients on Hemodialysis (32.6KB)
R&D
Feb.03.2017
Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer (182KB)
Licensing
Jan.21.2017
Ono Pharmaceutical Company and Bristol-Myers Squibb Enter Settlement and License Agreement with Merck for Anti-PD-1 Antibody Patent Infringement Litigation (81.7KB)
R&D
Jan.20.2017
Bristol-Myers Squibb Provides Regulatory Update in First-line Lung Cancer (137KB)
R&D
Jan.20.2017
Data with OPDIVO® (nivolumab) Intravenous Infusion in Gastric Cancer from Phase III Clinical Study (ONO-4538-12) Presented at 2017 Gastrointestinal Cancer Symposium (ASCO GI 2017) (77.6KB)