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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(72 KB)
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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(74 KB)
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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(25 KB)
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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 KB)
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- Dec.02.2015
- Bristol-Myers Squibb Announces Regulatory Update for Opdivo (nivolumab) in Advanced Melanoma(146 KB)
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- Dec.01.2015
- HELSINN ANNOUNCES EUROPEAN MEDICINES AGENCY ACCEPTANCE OF MARKETING AUTHORIZATION APPLICATION FOR ANAMORELIN HCL(37 KB)
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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(176 KB)
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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(179 KB)
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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(172 KB)
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- Nov.24.2015
- European Commission Approves Kyprolis® (carfilzomib) For Combination Use In The Treatment Of Patients With Relapsed Multiple Myeloma(28 KB)
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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(166 KB)
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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(126 KB)
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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(137 KB)
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- Oct.26.2015
- Revisions of Consolidated Financial Forecasts(19 KB)
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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(167 KB)
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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(193 KB)
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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(137 KB)
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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(176 KB)
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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(166 KB)
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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(406 KB)
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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(53 KB)
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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(154 KB)
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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(151 KB)
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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(230 KB)
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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 KB)
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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(153 KB)
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- Aug.26.2015
- AMGEN SUBMITS APPLICATION IN THE US FOR ETELCALCETIDE (AMG 416) FOR THE TREATMENT OF SECONDARY HYPERPARATHYROIDISM(16 KB)
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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(17 KB)
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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-(57 KB)
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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(126 KB)
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- Aug.04.2015
- Announcement on Financial Results for FY2015 1Q
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- Jul.31.2015
- ONO submits manufacturing approval partial amendment application for OPDIVO® (generic name: Nivolumab) for treatment of patients with unresectable melanoma in Japan(19 KB)
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- Jul.28.2015
- European Medicines Agency Validates Two Parallel Type II Variation Applications to Extend the Opdivo (nivolumab) Indication in Europe(132 KB)
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- Jul.27.2015
- FDA Approves Kyprolis® (carfilzomib) For Combination Use In The Treatment Of Patients With Relapsed Multiple Myeloma(82 KB)
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- Jul.22.2015
- CheckMate-025 (global clinical trial), a Pivotal Phase III Opdivo (nivolumab) Renal Cancer Trial Stopped Early(130 KB)
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- Jul.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(164 KB)
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- Jul.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(19 KB)
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- Jul.13.2015
- Notice Concerning Determination of Details of Issuance of Stock Options (Stock Acquisition Rights)(41 KB)
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- Jun.26.2015
- Notice Concerning Issuance of Stock Options (Stock Acquisition Rights)(112 KB)
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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(158 KB)
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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(273 KB)
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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(175 KB)
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- Jun.05.2015
- Phase III CheckMate-067 Trial Demonstrates Superior Progression-Free Survival of Opdivo+Yervoy Regimenor Opdivo Monotherapy vs. Yervoy Monotherapy in Previously Untreated Patients with Advanced Melanoma(176 KB)
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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(362 KB)
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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(203 KB)
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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(143 KB)
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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(152 KB)
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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(23 KB)
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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(143 KB)
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- May.12.2015
- Notice Concerning Issuance of Stock Options (Stock Acquisition Rights)(25 KB)
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- May.12.2015
- Position and Policies Concerning the Reduction of the Minimum Investment Unit(21 KB)
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- May.12.2015
- Announcement on Financial Results for FY2014
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- Apr.30.2015
- Bristol-Myers Squibb Company announced about Opdivo (nivolumab).(163 KB)
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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(306 KB)
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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(184 KB)
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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)(19 KB)
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- Apr.21.2015
- CheckMate -057, a Pivotal III Opdivo (nivolumab) Lung Cancer Trial, Stopped Early(147 KB)
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- Apr.06.2015
- Announcement on Candidates of Members of the Board of Directors, Corporate Auditors and Corporate Officers(40 KB)
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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(356 KB)
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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(98 KB)
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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(97 KB)
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- Mar.19.2015
- Opicapone significantly improves OFF-time in fluctuating Parkinson's Disease patients as add-on to levodopa(117 KB)
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- Mar.16.2015
- ONO and CCPC enter into an agreement on development and commercialization of Limaprost in Taiwan(18 KB)
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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(152 KB)
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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(138 KB)
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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 KB)
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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(12 KB)
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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)(64 KB)
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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(106 KB)
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- Jan.15.2015
- Outsourcing of Logistics Operation(39 KB)
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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(145 KB)