2018.

• Dec.27.2018 R & D

  ONO Submits an Application for Manufacturing and Marketing Approval in Japan for Ivabradine Hydrochloride (ONO-1162) for the Treatment of Chronic Heart Failure(113 KB)

• Nov.27.2018 R & D

  Bristol-Myers Squibb Announces CheckMate -451 Study Did Not Meet Primary Endpoint of Overall Survival with Opdivo Plus Yervoy Vs. Placebo as A Maintenance Therapy in Patients with Extensive-Stage Small Cell Lung Cancer After Completion of First-Line Chemotherapy(47 KB)

• Nov.27.2018 R & D

  ONO Submits an Application for Manufacturing and Marketing Approval of Anamorelin (ONO-7643), a Ghrelin Receptor Agonist, for the Treatment of Cancer Cachexia in Japan(36 KB)

• Nov.16.2018 R & D

  Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma(47 KB)

• Nov.02.2018 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for Supplemental Indication of Intermediate and Poor Risk Previously Untreated Advanced Renal Cell Carcinoma in Combination Therapy with Ipilimumab in Taiwan(70 KB)

• Nov.01.2018 Management / Finance

  Announcement on Financial Results for FY2018 2Q

• Oct.23.2018 R & D

  Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Demonstrates Durable Clinical Benefit in Previously Untreated Patients with MSI-H or dMMR Metastatic Colorectal Cancer(47 KB)

• Oct.23.2018 R & D

  Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Demonstrates Durable Four-Year Survival Benefits in Patients with Advanced Melanoma(47 KB)

• Oct.23.2018 R & D

  Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Results in Significantly Longer Treatment-Free Survival in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma(47 KB)

• Oct.22.2018 R & D

  Bristol-Myers Squibb Provides Update on the Ongoing Regulatory Review of Opdivo Plus Low-Dose Yervoy in First-Line Lung Cancer Patients with Tumor Mutational Burden ≥10 mut/Mb(88 KB)

• Oct.22.2018 R & D

  Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Shows Promising Results in Patients with Advanced Form of Bladder Cancer(46 KB)

• Oct.15.2018 R & D

  Bristol-Myers Squibb Announces Phase 3 CheckMate -331 Study Does Not Meet Primary Endpoint of Overall Survival with Opdivo Versus Chemotherapy in Patients with Previously Treated Relapsed Small Cell Lung Cancer(47 KB)

• Oct.10.2018 R & D

  U.S. Food and Drug Administration Accepts Karyopharm's New Drug Application for Selinexor and Grants Priority Review(34 KB)

• Oct.09.2018 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for Indication of Previously Untreated Intermediate and Poor Risk Advanced Renal Cell Carcinoma in Combination with Ipilimumab, and Change in Administration Method for Intravenous Infusion Duration in South Korea(92 KB)

• Oct.03.2018 R & D

  FDA Approves KYPROLIS® (Carfilzomib) Once-Weekly 70 mg/㎡ in Combination with Dexamethasone (Kd70) for Patients with Relapsed or Refractory Multiple Myeloma(36 KB)

• Oct.01.2018 Products

  ONO Announces Transfer of 11 Long-listed Products (5 Brands: Injection) to Maruishi in Japan(75 KB)

• Sep.25.2018 R & D

  European Commission Approves BRAFTOVI® (encorafenib) in Combination with MEKTOVI® (binimetinib) for Advanced BRAF-mutant Melanoma(35 KB)

• Sep.20.2018 Sustainability

  Support for Relief Efforts to Hokkaido Eastern Iburi Earthquake in Japan(30 KB)

• Sep.19.2018 R & D

  ONO and Novartis Submit a Supplemental Application for Formulation with New Ingredient of Rivastach® Patch and Exelon® Patch for Treatment of Alzheimer's Disease Dementia(67 KB)

• Sep.18.2018 Licensing

  ONO announces collaboration with Fate Therapeutics for two iPSC-derived CAR-T Therapies for Cancers(66 KB)

• Aug.31.2018 R & D

  Amgen Submits Supplemental New Drug Application for KYPROLIS® (carfilzomib) Once-Weekly 70 mg/㎡ in Combination with Dexamethasone(36 KB)

• Aug.28.2018 Licensing

  Ono Enters into Collaboration Agreement on Combination Therapy of Opdivo® and Rubraca® with BMS and Clovis(68 KB)

• Aug.22.2018 Licensing

  Ono and Takeda Initiate Clinical Collaboration on Combination Therapy of Opdivo® (Nivolumab) and Cabozantinib in Japan(74 KB)

• Aug.21.2018 Corporate

  Announcement of Expansion of Initiatives to Return the Allowances Corresponding to Overtime Work Reduced through Work Style Reform to Employees and Society(103 KB)

• Aug.21.2018 R & D

  Opdivo Approved for Supplemental Applications for Expanded Indications of Malignant Pleural Mesothelioma and Adjuvant Treatment of Melanoma, Change in Dosage and Administration (D&A) of Single Dosing Regimen, and Expanded indication of Renal Cell Carcinoma in Opdivo and Yervoy Combination Therapy(78 KB)

• Aug.20.2018 R & D

  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as the First New Medication in Nearly 20 Years for Certain Patients with Previously Treated Small Cell Lung Cancer(47 KB)

• Aug.08.2018 R & D

  Array BioPharma Receives FDA Breakthrough Therapy Designation for BRAFTOVI^TM in Combination with MEKTOVI® and Cetuximab for BRAF^V600E-mutant Metastatic Colorectal Cancer(34 KB)

• Aug.07.2018 R & D

  Karyopharm Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma(34 KB)

• Aug.02.2018 R & D

  European Commission Approves Bristol-Myers Squibb's Opdivo (nivolumab) for the Adjuvant Treatment of Adult Patients with Melanoma with Involvement of Lymph Nodes or Metastatic Disease Who Have Undergone Complete Resection(47 KB)

• Aug.01.2018 Management / Finance

  Announcement on Financial Results for FY2018 1Q

• Jul.30.2018 R & D

  BRAFTOVI™ (encorafenib) + MEKTOVI® (binimetinib) Receives Positive CHMP Opinion for Advanced BRAF-mutant Melanoma(34 KB)

• Jul.30.2018 R & D

  ONO Submits Supplemental Application of ONOACT® for Intravenous Infusion 50mg・150mg, Short-Acting Selective β₁ Blocker for Indication of Ventricular Arrhythmia for a Partial Change in Approved Items of Manufacturing and Marketing Approval in Japan(118 KB)

• Jul.19.2018 R & D

  Karyopharm Initiates Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Selinexor as a Treatment for Patients with Penta-Refractory Multiple Myeloma(33 KB)

• Jul.13.2018 Sustainability

  ONO Announces the Number of Medical Institutes at Dementia-Related Information Website “Dementia Healthcare Connected with Smile and Heart” Reached 400 Institutes, Where Interview Articles from the Institutes Have Been Posted(33 KB)

• Jul.13.2018 Sustainability

  Support for the Torrential Rain Damage in Western Japan(36 KB)

• Jul.12.2018 R & D

  Opdivo + Low-Dose Yervoy is the First Immuno-Oncology Combination Approved for MSI-H/dMMR mCRC Patients Who Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin and Irinotecan(47 KB)

• Jul.09.2018 Management / Finance

  Notice Concerning Determination of Details of Issuance of Stock Options (Stock Acquisition Rights)(132 KB)

• Jul.02.2018 R & D

  Bristol-Myers Squibb Receives Positive CHMP Opinion Recommending Approval of Opdivo (nivolumab) for the Adjuvant Treatment of Adult Patients with Melanoma First and only PD-1 agent to receive positive CHMP opinion in the adjuvant setting(47 KB)

• Jun.29.2018 R & D

  Announcement of an Approval for OPALMON TABLET5μg, an Oral Prostaglandin E₁ Analogue, in Thailand(35 KB)

• Jun.28.2018 Sustainability

  Support for Relief Efforts to Earthquake in Northern Part of Osaka(36 KB)

• Jun.28.2018 R & D

  Array Biopharma Announces FDA Approval of Braftovi™ (Encorafenib) in Combination with Mektovi® (Binimetinib)(50 KB)

• Jun.25.2018 R & D

  Array BioPharma Announces a 62% Observed Overall Survival at One Year from the Phase 3 BEACON CRC Safety Lead-In of the Combination of Encorafenib, Binimetinib and Cetuximab in BRAF-Mutant CRC at the ESMO 20th World Congress on Gastrointestinal Cancer(35 KB)

• Jun.22.2018 R & D

  U.S. Food and Drug Administration (FDA) Accepts Application for Opdivo Plus Low-Dose Yervoy for Treatment of First-Line Non-Small Cell Lung Cancer in Patients with Tumor Mutational Burden ≥10 mut/Mb(99 KB)

• Jun.22.2018 Management / Finance

  Notice Concerning Issuance of Stock Options (Stock Acquisition Rights)(252 KB)

• Jun.18.2018 R & D

  China National Drug Administration Approves Country's First Immuno-Oncology Agent, Opdivo (nivolumab injection), for Previously Treated Non-Small Cell Lung Cancer (NSCLC)(46 KB)

• Jun.05.2018 R & D

  Array BioPharma Announces Additional Median Overall Survival Results of Encorafenib and Binimetinib in Patients with BRAF-mutant Advanced Melanoma(35 KB)

• Jun.05.2018 R & D

  Opdivo (nivolumab) 3 mg/kg Demonstrates Sustained, Superior Recurrence-Free Survival Versus Yervoy (ipilimumab) 10 mg/kg for Broad Range of Patients with Resected Stage III or IV Melanoma(47 KB)

• Jun.05.2018 R & D

  Opdivo Plus Chemotherapy Showed Improved Progression-Free Survival Versus Chemotherapy in First-Line Lung Cancer Patients with PD-L1 <1%, in CheckMate -227 Study to Be Presented at ASCO 2018(103 KB)

• Jun.04.2018 R & D

  Opdivo (nivolumab) Plus Low-Dose (1mg/kg) Yervoy (ipilimumab) Provided Significant and Sustained Health-Related Quality of Life Improvements in Intermediate- and Poor-Risk Patients with Advanced Renal Cell Carcinoma in CheckMate -214 Study(48 KB)

• May.30.2018 R & D

  Announcement on Establishment of Immune-mediated Inflammatory Diseases Consortium for Drug Development(34 KB)

• May.25.2018 R & D

  ONO and BMSKK Receive Approval for Opdivo® and Yervoy® Combination Therapy for Treatment of Unresectable Melanoma as a Partial Change in Approved Items of Manufacturing and Marketing Approval in Japan(72 KB)

• May.10.2018 Management / Finance

  Announcement on Financial Results for FY2017

• May.07.2018 R & D

  Karyopharm Announces Positive Top-Line Data from Phase 2b STORM Study Evaluating Selinexor in Patients with Penta-Refractory Multiple Myeloma(66 KB)

• May.07.2018 R & D

  European Medicines Agency Validates Bristol-Myers Squibb’s Type II Variation Application for Opdivo Plus Yervoy Combination for Treatment of First-Line Metastatic Non-Small Cell Lung Cancer (NSCLC)(68 KB)

• Apr.26.2018 R & D

  ONO Submits an Application for Manufacturing and Marketing Approval for Metyrosine (ONO-5371), a Tyrosine Hydroxylase Inhibitor, for Improvement of Status of Catecholamine Excess Secretion and its Accompanying Symptoms in Patients with Pheochromocytoma in Japan(56 KB)

• Apr.25.2018 R & D

  ONO Submits Applications for Manufacturing and Marketing Approval for Encorafenib, a BRAF Inhibitor and Binimetinib, a MEK Inhibitor for Indication of Unresectable BRAF-mutant Melanoma in Japan(67 KB)

• Apr.19.2018 R & D

  U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo (nivolumab) in Previously Treated Patients with Small Cell Lung Cancer and Grants Priority Review(43 KB)

• Apr.18.2018 R & D

  U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combination as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma(45 KB)

• Apr.17.2018 R & D

  In CheckMate -141, Opdivo (nivolumab) Demonstrated Sustained Overall Survival (OS) Advantage over Standard of Care in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)(45 KB)

• Apr.17.2018 R & D

  Opdivo Plus Low-Dose Yervoy Combination Reduces the Risk of Progression or Death by 42% Versus Chemotherapy in First-Line Lung Cancer Patients with High Tumor Mutational Burden (TMB)(70 KB)

• Apr.16.2018 R & D

  Opdivo (nivolumab), First PD-1 Inhibitor to Demonstrate Superior Survival Benefit Compared with Chemotherapy in a Predominantly Chinese Population with Previously Treated Non-Small Cell Lung Cancer (NSCLC)(38 KB)

• Apr.12.2018 R & D

  Karyopharm's Selinexor Receives Fast Track Designation from FDA for the Treatment of Patients with Penta-Refractory Multiple Myeloma(23 KB)

• Apr.05.2018 Corporate

  Announcement on Candidates of Members of the Board of Directors and Corporate Officers(101 KB)

• Mar.28.2018 R & D

  U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb's Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for Previously Treated Patients with MSI-H or dMMR Metastatic Colorectal Cancer for Priority Review(44 KB)

• Mar.26.2018 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved for Supplemental Indication of Advanced or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma and for Expanded Use in Recurrent or Advanced Classical Hodgkin Lymphoma in South Korea(43 KB)

• Mar.19.2018 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved in Taiwan for Supplemental Indication of Hepatocellular Carcinoma Previously Treated with Sorafenib(65 KB)

• Mar.14.2018 Licensing

  Ono Enters into New Collaboration Agreement with Merus N.V.(104 KB)

• Mar.01.2018 Corporate

  Completion of a New Tokyo Building(208 KB)

• Feb.23.2018 R & D

  Orencia® for Intravenous Infusion 250 mg, Selective T-cell Co-stimulation Modulator: Approval for Additional Indication of Active Polyarticular Juvenile Idiopathic Arthritis for Partial Change in Approved items of Manufacturing and Marketing Approval in Japan(164 KB)

• Feb.13.2018 Sustainability

  Support for Relief Efforts to Eastern Taiwan Earthquake(21 KB)

• Feb.07.2018 R & D

  Encorafenib and Binimetinib Combination Treatment Demonstrates 33.6 Month Median Overall Survival (OS) in Patients with BRAF-Mutant Melanoma in Phase 3 COLUMBUS Trial(31 KB)

• Feb.06.2018 R & D

  Pivotal Phase 3 CheckMate -227 Study Demonstrates Superior Progression-Free Survival (PFS) with the Opdivo Plus Yervoy Combination Versus Chemotherapy in First-Line Non-Small Cell Lung Cancer (NSCLC) Patients with High Tumor Mutation Burden (TMB)(87 KB)

• Feb.02.2018 Management / Finance

  Announcement on Financial Results for FY2017 3Q

• Jan.25.2018 R & D

  Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Demonstrates Clinical Activity in Previously Treated Patients with dMMR or MSI-H Metastatic Colorectal Cancer(44 KB)

• Jan.23.2018 R & D

  Opdivo® (Nivolumab) Intravenous Infusion Approved in Taiwan for Supplemental Indication of Advanced or Recurrent Gastric Cancer or Gastro-esophageal Junction Cancer(65 KB)

• Jan.22.2018 R & D

  Combination of Encorafenib, Binimetinib and Cetuximab Demonstrated an 8 Month Median Progression-Free Survival in BRAF-Mutant Colorectal Cancer in Updated Safety Lead-In Results from BEACON Phase 3 Trial(31 KB)

• Jan.15.2018 R & D

  ONO and BMSKK Submit Supplemental Application for Opdivo and Yervoy Combination Therapy for Unresctable or Metastatic Renal Cell Carcinoma in Japan for a Partial Change in Approved Items of Manufacturing and Marketing Approval(47 KB)