Eisai Co Ltd (ESALF) 41.6500 $ESALF
Lorcaserin HCl Data to be Presented at the American Society of Bariatric Physicians' 64th Annual Obesity & Associated Conditions Symposium
PR Newswire - Wed Sep 10, 7:00AM CDT
Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that data from the Phase 3 clinical trial program for BELVIQ® (lorcaserin HCl) CIV will be presented at the American Society of Bariatric Physicians' (ASBP) 64th Annual Obesity & Associated Conditions Symposium taking place September 10-13, 2014, in Austin, Texas.
Eisai Sells U.S. Rights to Zonegran® (zonisamide) Capsules to Concordia Pharmaceuticals Inc.
PR Newswire - Wed Sep 03, 6:00AM CDT
Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced it has entered into an agreement with Concordia Pharmaceuticals Inc. ("Concordia"
, a subsidiary of Concordia Healthcare Corp., to purchase Eisai's U.S. and Puerto Rican commercialization and distribution rights to Zonegran. As part of the deal terms, Eisai will receive full payment from Concordia upon closing. In addition, Eisai and Concordia are expected to enter into a supply agreement under which Eisai will serve as Concordia's supplier of Zonegran for the U.S. and Puerto Rican markets.
Global Peptic Ulcer Drugs Market 2014-2018: Key Vendors are AstraZeneca, Eisai, Daewoong and Takeda
M2 - Fri Aug 29, 3:47AM CDT
Research and Markets (http://www.researchandmarkets.com/research/hx23pt/global_peptic) has announced the addition of the "Global Peptic Ulcer Drugs Market 2014-2018" report to their offering. A peptic ulcer is an open lesion that develops on the mucosal lining of the stomach and small intestine because of the caustic effect of the gastric acids and enzymes in these organs. The symptoms of peptic ulcers are pain in the abdomen, nausea, vomiting, and bloated stomach. The major symptoms include bleeding from the ulcer, which can be life-threatening. It is detected by bloody and sticky stools, often black in color. Peptic ulcers are caused mainly by a Helicobacter pylori infection followed by the overuse of OTC NSAIDs such as Naproxen, Aspirin and Ibuprofen. Peptic ulcers can be of two types based on the site of the ulcer: gastric ulcer and duodenal ulcer. The analysts forecast the Global Peptic Ulcer Drugs market to grow at a CAGR of 2.9 percent over the period 2013-2018. This report covers the present scenario and the growth prospects of the Global Peptic Ulcer Drugs market for the period 2014-2018. To calculate the market size, the report considers the revenue generated from the sales of various drugs used in the treatment of peptic ulcers that are available in the market. Key Topics Covered: 01. Executive Summary 02. List of Abbreviations 03. Scope of the Report 04. Product Profiles 05. Market Research Methodology 06. Introduction 07. Market Landscape 08. Pipeline Portfolio 09. Market Segmentation by Class of Drugs 10. Geographical Segmentation 11. Buying Criteria 12. Market Growth Drivers 13. Drivers and their Impact 14. Market Challenges 15. Impact of Drivers and Challenges 16. Market Trends 17. Trends and their Impact 18. Vendor Landscape 19. Key Vendor Analysis Companies Mentioned: - AstraZeneca plc - Eisai Co. Ltd. - Daewoong Pharmaceutical Co. Ltd. - Takeda Pharmaceutical Co. Ltd. - Daiichi Sankyo - Dr. Reddy's Laboratories - Eumedica - Ferring Pharmaceuticals - Horizon Pharma - Johnson and Johnson - Merck Sharp and Dohme - Otsuka Holdings - Pfizer - PharmaKing - Pozen - Rottapharm Madaus - Taiho Pharmaceutical - Zeria Pharmaceutical and Zuventus Healthcare For more information visit http://www.researchandmarkets.com/research/hx...bal_peptic
Eisai Submits Applications for Antiepilepsy Agent Fycompa Simultaneously In Europe and U.S.
JCN Newswire - Wed Aug 20, 1:21AM CDT
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai" announced today that it has submitted applications to regulatory authorities in the U.S. and Europe (the FDA and EMA respectively) for the indication expansion of its in-house developed antiepileptic drug Fycompa (generic name: perampanel) as an adjunctive treatment of primary generalized tonic-clonic seizures (PGTC).
Eisai Supports Earthquake Relief Efforts in Yunnan, China
JCN Newswire - Wed Aug 06, 8:51PM CDT
Eisai expresses its heartfelt sympathies to all those affected by the recent earthquake which occurred in Ludian county of Zhaotong city, Yunnan province, China.
EMA Grants Eisai's Anticancer Agent Lenvatinib Request for Accelerated Assessment
JCN Newswire - Wed Jul 30, 9:48PM CDT
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai" announced today that its U.K. subsidiary Eisai Europe Ltd. has been granted an accelerated review by the European Medicines Agency (EMA) for its in-house developed anticancer agent lenvatinib mesylate ("lenvatinib" in the treatment of radioiodine-refractory differentiated thyroid cancer.
Global Insomnia Clinical Trials Review, H2, 2014 Featuring 10 Companies & 10 Institutes
M2 - Thu Jul 17, 8:37AM CDT
Research and Markets (http://www.researchandmarkets.com/research/xplssq/insomnia_global) has announced the addition of the "Insomnia Global Clinical Trials Review, H2, 2014" report to their offering. Insomnia Global Clinical Trials Review, H2, 2014" provides data on the Insomnia clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Insomnia. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Insomnia. Scope - Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type - Listings of discontinued trials (suspended, withdrawn and terminated) Clinical Trial Overview of Top Companies - Takeda Pharmaceutical Company Limited - Merck & Co., Inc. - Dainippon Sumitomo Pharma Co., Ltd. - Sanofi - Neurocrine Biosciences, Inc. - Pfizer Inc. - GlaxoSmithKline plc - Neurim Pharmaceuticals Ltd - Eisai Co., Ltd. - Actelion Ltd Clinical Trial Overview of Top Institutes / Government - University of Rochester - Duke University - U.S. Department of Veterans Affairs - Karolinska Institute - University of Pittsburgh - Brigham and Women's Hospital - Stanford University - The University of Hong Kong - Massachusetts General Hospital - National Institute of Mental Health For more information visit http://www.researchandmarkets.com/research/xp...nia_global
Global Alzheimer's Drugs Market 2014-2018 with Eisai Co. Forest Laboratories, Janssen Pharmaceuticals & Novartis Dominating
M2 - Fri Jul 11, 9:01AM CDT
Research and Markets (http://www.researchandmarkets.com/research/wldkgv/global) has announced the addition of the "Global Alzheimer's Drugs Market 2014-2018" report to their offering. The incidence rates for Alzheimer's disease are increasing, and the global Alzheimer's population is expected to double by 2030. Currently, it is estimated that 5 million Americans suffering from Alzheimer's disease are aged 65 years or above. This number might reach 13.8 million by 2050 as the baby boom generation ages. In the US, Alzheimer's disease is the fifth highest cause factor for deaths among people aged 65 years and above. It has been recognized as the only factor among the top 10 death-causing factors in America for which therapy is not available, preventing or slowing down the progression of disease. The number of deaths resulting from Alzheimer's disease increased by 68 percent during the period of 2000-2010 and this number is expected to increase further during the next decade. In the US, it is estimated that about 7,00,000 people aged 65 years or above will die from Alzheimer's disease in 2014. The incidence rate of Alzheimer's disease is increasing rapidly owing to a rise in the elderly population. In the US, the 2014 incidence rate of Alzheimer's disease for people aged 65 years or above is expected to reach 4,69,000 and this number is expected to double by 2050. According to the report, the Global Alzheimer's Drugs market is driven by several factors, of which the increase in the global aging population is one of the major drivers. The incidence of Alzheimer's disease is growing continuously, mainly because of an increase in the aging population, especially those aged 65 years or above. It is estimated about 596.8 million people will reach 65 years and above in 2014, and this number is expected to reach 681.2 million by 2018. Furthermore, the report states that one of the main challenges is the poor rate of Alzheimer's disease diagnosis. In developed economies, merely 20-50 percent of dementia cases are diagnosed while in developing economies such as India nearly 90 percent cases remain undiagnosed. The lack of diagnosis hampers the effective management of this disease. Key Vendors: - Eisai Co., Ltd. - Forest Laboratories Inc. - Janssen Pharmaceuticals Inc. - Novartis AG Other Prominent Vendors: - Adamas Pharmaceuticals Inc. - Archer Pharmaceuticals Inc. - Eli Lilly and Co. - F. Hoffmann-La Roche Ltd. - FORUM Pharmaceuticals Inc. - H. Lundbeck A/S - Merck & Co., Inc. - MorphoSys AG - Otsuka Pharmaceutical Development & Commercialization Inc./ Otsuka America Pharmaceutical, Inc. - Takeda Pharmaceutical Co., Ltd. - TauRx Pharmaceuticals Ltd. - Zinfandel Pharmaceuticals Inc. Key Topics Covered: - Executive Summary - List of Abbreviations - Scope of the Report - Market Research Methodology - Introduction - Disease Overview - Alzheimer's Disease - Market Landscape - Market Segmentation by MOA - Market Assessment of Top Drugs - Competitive Assessment of Top Drugs - Focus on Alzheimer's Research - Geographical Segmentation - Buying Criteria - Market Growth Drivers - Drivers and their Impact - Market Challenges - Impact of Drivers and Challenges - Market Trends - Trends and their Impact - Vendor Landscape - Future Vendors Expected To Tap the Market - Key Vendor Analysis For more information visit http://www.researchandmarkets.com/research/wldkgv/global
Companion Diagnostics in Personalized Medicine and Cancer Therapy
M2 - Mon Jul 07, 8:04AM CDT
Research and Markets (http://www.researchandmarkets.com/research/35n4zz/companion) has announced the addition of the "Companion Diagnostics in Personalized Medicine and Cancer Therapy" report to their offering. Companion diagnostics (CDx) refers to a particular clinical diagnostic test that is under evaluation and is specifically linked to a known drug therapy. This linkage could be important in the therapeutic application and clinical outcome of a drug, such as with personalized medicine for oncology patients. The molecular diagnostics field plays a vital part in personalized medicine and has greatly expanded over the past twenty years, expanding by more than 20% annually compared to most other laboratory procedures. Research will continue to produce an increased understanding of disease processes, and diagnostics manufacturers will continue to expand and refine the technology and automation needed for clinical testing. Companion diagnostics, although smaller at present, is one of the fastest growing segments in the in vitro diagnostic (IVD) market. And while the concept of a drug-diagnostic combination is not new, it has only recently started to generate interest with the move of healthcare towards pharmacogenomics. This TriMark Publications report examines the use of companion diagnostics in personalized medicine and cancer therapy. The study provides a qualitative and quantitative review of the industry, including cancer biomarker tests, pharmacogenomics tests, recurrence prediction tests, blood-based technologies, proteomics and regulatory trends. Moreover, this analysis profiles the leading companies that are developing and manufacturing companion diagnostics solutions. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market share data are also included. Key Topics Covered: 1. Overview 1.1 Statement of Report 1.2 About This Report 1.3 Scope of the Report 1.4 Objectives 1.5 Methodology 1.6 Executive Summary 2. Companion Diagnostics and Personalized Medicine 2.1 Scope of This Section 2.2 Introduction to Companion Diagnostics and Personalized Medicine 2.3 Drug Metabolism, Companion Diagnostics and Personalized Medicine 2.4 Examples of Personalized Medicine and Companion Diagnostic Tests 2.5 Personalized Medicine and Companion Diagnostic Testing Product Pipeline 2.6 The Personalized Medicine Coalition (PMC) 2.7 Regulatory Trends and Guidelines in the Personalized Medicine Space 2.7.1 The Changing Regulatory Landscape for Personalized Medicine 2.8 Companion Diagnostics Play an Increasing Role in Cancer Care 2.9 Specific Examples of Clinical Situations where Companion Diagnostics are being Deployed 2.9.1 Epidermal Growth Factor Receptor Assay 2.9.2 Individualized Warfarin Therapy 2.9.3 UGT1A1 Molecular Assay for Camptosar 2.9.4 Response to Gleevec in Gastrointestinal Stromal Tumors (GISTs) 2.9.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases 2.9.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Enter Companion Diagnostics 2.9.7 Roche's Metastatic Melanoma Treatment, Zelboraf (vemurafenib) 2.9.8 Abbott's Late-Stage NSCLC Treatment, Xalkori (crizotinib) 2.10 Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness 2.11 Value Chain 2.12 Impact of Companion Diagnostics/Personalized Medicine on Drug Clinical Trials 3. Companion Diagnostics: Qualitative and Quantitative Market Analysis 3.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics 3.2 Costs of Companion Diagnostics in Healthcare Expenditures 3.3 Molecular Diagnostic Market 3.4 Molecular Diagnostics Technology Platforms and Their Impact on Clinical Medicine 3.5 Snapshot of Companion Diagnostics Industry Structure 3.6 The Case for Theranostics 3.7 Companion Diagnostics Market Analysis Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters 4. Trends and Overview 4.1 Companion Diagnostics: Industry SWOT Analysis 4.2 Macro Trends in Companion Diagnostics 4.3 Challenges for Companion Diagnostics Development 4.4 Timeline for Impact of Various Segments in Companion Diagnostics 4.5 Use of Proteomics to Develop Individualized Tests 4.6 The Market Problem: Finding Value with Diagnostics for Personalized Medicine 5. Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics 5.1 Sector Overview 5.1.1 Impact of New Technology Platforms 5.1.2 Impact on Drug Discovery 5.1.3 Biomarkers as Endpoints in Drug Discovery 5.1.4 Targeted Therapy 5.2 Companion Diagnostics on the Market 5.3 Epidermal Growth Factor Receptor Companions 5.3.1 Bevacizamab (Avastin) 5.3.2 EGFR for CRC and Camptosar (Irinotecan) 5.3.2.1 Companion Diagnostic Test Developed for UGT1A1 for Irinotecan 5.3.2.2 Companion Diagnostic Test Developed for Bristol-Myers' SPRYCEL 5.3.3 EGFR Express and Erbitux (Cetuximab) 5.3.4 HER2 and Heceptin (Trastuzumab) 5.3.4.1 Bayer's Advia Centaur HER2/neu Assay 5.3.4.2 Companies Marketing HER2/neu Assays 5.3.5 Iressa and Tarceva Companion Test 5.3.6 Tykerb (GlaxoSmithKline (GSK)) and Vectibix (Amgen) Companion Tests 5.3.7 EGFRx Assay 5.3.8 Monogram eTag 5.3.9 Veripath OncoDiagnostics EGFR PharmDX 5.3.10 NSCLC Patients with EGFR Mutation 5.3.11 A Personalized Medicine Program for CML 5.4 Companions Based on Myriad's IVDMIA Technology 5.4.1 Myriad's TheraGuide 5-FU 5.4.2 Myriad's BRCA Companion Diagnostics Testing for BioMarin's PARP Inhibitor BMN 673 5.5 Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib 5.5.1 TheraScreen: EGFR29 5.5.2 The K-RAS Mutation Detection Kit 5.6 Irinotecan and UGT1A1 5.7 Gleevec (Imatinib) Companions 5.7.1 DakoCytomation's c-Kit (9.7) pharmDx 5.8 Companion Diagnostics Involving Metabolizing Enzymes 5.8.1 Companions for TMPT, CYP2C9 and UGT1A1 Enzymes 5.8.2 Companions for Aromatase Inhibitors 5.8.3 Companions for Actos and Avandia 5.9 Drivers and Barriers to Companion Diagnostics 5.10 Partnerships with Pharma Companies to Identify Therapeutic Targets 5.11 Circulating Tumor Cell Assay: Prognostic and Predictive Factors for Breast Cancer 5.12 Companion Diagnostics Used by Clinical Service Laboratories 5.13 New Technologies and Products under Development 5.13.1 OncoMethylome (now MDx Health) 5.13.2 Ventana Medical Systems Inks Companion Diagnostic Deal with Syndax for Lung Cancer Drug 5.13.3 Abbott Expands Agreement with GSK to Include Development of a Companion Diagnostic Test for the PRAME Antigen 5.14 Pharmacogenomics Tests 5.14.1 MGMT Methylation Assay 5.14.2 Other Pharmacogenomic Opportunities 5.15 Recurrence Prediction Tests 5.16 Blood-based Technologies 5.16.1 Oncotech 5.17 Monogram Biosciences HIV Personalized Platform 5.18 Wako LBA\AFP Test for Liver Cancer 5.19 Future Developments for Companion Diagnostics 5.20 Drug Response Predictors 6. Business and Regulatory Trends in the Companion Biomarker Testing Sector 6.1 Industry Consolidation 6.2 Breath of Product Offering and Pricing 6.3 Government Regulation of Medical Devices 6.3.1 FDA Guidance on Drug Test Co-development 6.3.2 Device Classes 6.3.3 Investigational Use of IVDMIAs 6.3.4 Post-market Requirements 6.3.5 Voluntary versus Required Submissions 6.3.6 Examples of Recent Voluntary Genomic Data Submissions 6.3.7 FDA Labeling Implications and Rules 6.3.8 Regulatory Activities in Companion Diagnostic Testing Translation of Diagnostic Testing Results into Clinical Practice 6.4 Strategic Business and Marketing Considerations 6.5 Commercial Opportunities in Companion Markers 6.6 Moderators of Growth 6.6.1 Roadblocks to Integrating Companion Biomarkers into Clinical Practice 6.6.2 Management of Targeted Therapeutics by Third-Party Payers 6.7 Biotechnology Industry Trends 6.8 Pharmaceutical Industry Trends 6.9 Acquisition, License Agreement, Partnerships 6.10 Legal Developments 6.11 Sales and Marketing Strategies for Tumor Marker Tests 6.11.1 International Markets 6.11.2 Europe 6.11.3 Central and South America 6.11.4 Asia-Pacific 6.12 Product Commercialization 6.13 Reimbursement 6.14 Self-Referral Rules 6.15 Health Insurance Portability and Accountability Act 6.16 Clinical Laboratory Improvement Amendments (CLIA) 6.17 In Vitro Diagnostic Directive (IVDD) and Medical Device Regulations 6.18 FDA's Quality System Regulation (QSR) 6.19 The FDA's OIVD on IVDMIAs 6.20 FDA's Qualification of Cancer Biomarkers 6.20.1 Regulatory Perspectives of Biomarker Validation 6.21 Genetic Tests and Medical Records 6.21.1 Laws against Genetic Discrimination 6.22 Global Drivers of Clinical Laboratory Testing 6.23 Global Outlook 6.24 Oncology Biomarker Qualification Initiative 6.25 FDA Critical Path 6.25.1 Examples of Drugs being Hindered due to Lack of Compliance with FDA Directives 6.26 Biomarkers and FDA's Voluntary Genomic Data Submission 6.27 From Personalized to Predictive Medicine 6.28 Analysis of Cost-Effectiveness at the Individual Level 6.29 The Patient and Advocate Perspective: An Evolution of Influence 6.30 Real-World Experiences Translating the Vision of Personalized Medicine into Practice 6.30.1 Evolving Business Models in Companion Diagnostics and Personalized Medicine 6.30.2 Current Pharma/Diagnostics Business Model Examples 6.31 Reimbursement and Value Creation 6.32 What is the Role of Governmental Agencies in Driving the Adoption of Companion Diagnostics? 6.33 What is the Role of the Insurance Industry in Driving the Adoption of pharmacogenomics (PGx)? 6.34 What is the Role of the Pharma Industry in Driving the Adoption of PGx? 6.35 FDA Guidance Document on Co-development 6.36 What is the Role of the Diagnostic Industry in Driving the Adoption of PGx? 6.37 What is the Future Role of PBMs in Laboratory Services? 7. Companies Entering the Companion Diagnostics Market 7.1 Industry Overview 7.1.1 20/20 GeneSystems, Inc. 7.1.2 Abbott Molecular, Inc. 7.1.3 Affymetrix, Inc. 7.1.4 Agendia BV 7.1.5 Agensys, Inc. 7.1.6 Agilent Technologies 7.1.7 Almac Group 7.1.8 AMDL, Inc. 7.1.9 Applied Biosystems 7.1.10 Asuragen, Inc. 7.1.11 Aureon Laboratories Corporation 7.1.12 Beckman Coulter, Inc. 7.1.13 Becton, Dickinson and Company (BD) Diagnostics - TriPath 7.1.14 Biocode Hycel 7.1.15 BioCurex, Inc. 7.1.16 Biodesix 7.1.17 Biomarker Technologies, LLC 7.1.18 Biomedical Diagnostics, LLC 7.1.19 Biomerica 7.1.20 bioM?rieux, Inc. 7.1.21 Biomira, Inc. 7.1.22 BioModa, Inc. 7.1.23 Bruker Daltonics 7.1.24 Byk Gulden 7.1.25 Cangen Biotechnologies, Inc. 7.1.26 Caprion Proteomics 7.1.27 Celera Diagnostics 7.1.28 Cepheid, Inc. 7.1.29 Clarient, Inc. 7.1.30 Claros Diagnostics 7.1.31 Clinical Data, Inc.: PGxHealth and Cogenics 7.1.32 Correlogic Systems, Inc. 7.1.33 CytoCore, Inc. (Formerly Known As Molecular Diagnostics, Inc.) 7.1.34 Cytogen Corporation (now EUSA Pharma) 7.1.35 Dako (Formerly DakoCytomation) 7.1.36 DiaDexus 7.1.37 DiagnoCure 7.1.38 DRG International 7.1.39 EDP Biotech Corporation 7.1.40 Eisai Co., Ltd. 7.1.41 Epigenomics 7.1.42 EXACT Sciences Corporation 7.1.43 Exagen Diagnostics 7.1.44 Gene Logic, Inc. 7.1.45 Genesis Genomics, Inc. (now known as Mitomics) 7.1.46 GenMark Diagnostics 7.1.47 Genomic Health 7.1.48 Gen-Probe, Inc. 7.1.49 Health Discovery Corporation 7.1.50 Hologic, Inc. (Formerly Cytyc Corporation) 7.1.51 Ikonisys, Inc. 7.1.52 Illumina 7.1.53 Immunomedics 7.1.54 Incyte 7.1.55 InterGenetics 7.1.56 Ipsogen 7.1.57 Johnson & Johnson 7.1.58 LabCorp 7.1.59 Life Technologies Corporation 7.1.60 Matritech, Inc. 7.1.61 Miraculins 7.1.62 Mitsubishi Kagaku latron 7.1.63 Monogram Biosciences (formerly ViroLogic Inc.) 7.1.64 Myriad Genetics, Inc. 7.1.65 NimbleGen Systems 7.1.66 Northwest Biotherapeutics, Inc. 7.1.67 Novartis MDx 7.1.68 Nycomed 7.1.69 Oncotech, Inc. 7.1.70 Oncothyreon, Inc. (Formerly known as Biomira) 7.1.71 Orion Genomics 7.1.72 Oxford BioTherapeutics (formerly Oxford Genome Sciences) 7.1.73 Panacea Pharmaceuticals, Inc. 7.1.74 Polymedco, Inc. 7.1.75 Power3 Medical Products 7.1.76 Prometheus 7.1.77 Proteome Systems Limited 7.1.78 Qiagen N.V. 7.1.79 Roche Molecular Diagnostics 7.1.80 Sanko Junyaku Co. Ltd. 7.1.81 SensiGen, LLC 7.1.82 Siemens Healthcare Diagnostics, Inc. 7.1.83 SuperArray Bioscience Corporation 7.1.84 Third Wave Technologies, Inc. (now owned by Hologic) 7.1.85 Tosoh Biosciences 7.1.86 TrimGen 7.1.87 Upstream Biosciences, Inc. 7.1.88 Ventana Medical Systems, Inc. 7.1.89 Veridex, LLC 7.1.90 Vermillion, Inc. (Formerly Ciphergen) 7.1.91 Vertex Pharmaceuticals, Inc. Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submissions A1.1 Introduction A1.2 Background A1.3 Submission Policy A1.3.1 General Principles A1.3.2 Specific Uses of Pharmacogenomic Data in Drug Development and Labeling A1.3.3 Benefits of Voluntary Submissions to Sponsors and FDA A1.4 Submission of Pharmacogenomic Data A1.4.1 Submission of Pharmacogenomic Data During the IND Phase A1.4.2 Submission of Pharmacogenomic Data to a New NDA, BLA or Supplement A1.4.3 Submission to a Previously Approved NDA or BLA A1.4.4 Compliance with 21 CFR Part 58 A1.4.5 Submission of Voluntary Genomic Data from Application-Independent Research A1.5 Format and Content of a VGDS A1.6 Process for Submitting Pharmacogenomic Data A1.7 Agency Review of VGDSs Appendix 2: FDA Issues Draft Companion Diagnostic Guidance Appendix 3: Histochemical Markers for Cancer Glossary INDEX OF FIGURES Figure 2.1: Personalizing Drug Treatment 18 Figure 2.2: Approaches to Personalized Medicine 19 Figure 2.3: The Phase I and II Processes of Drug Metabolism 22 Figure 2.4: Hepatic Distribution of Human CYP450 23 Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism 24 Figure 2.6: Genetic Components Determine Drug Metabolism 24 Figure 2.7: Personalized Medicine Drugs in Development 29 Figure 2.8: Healthcare Value Chain 49 Figure 3.1: From Genetic Content to Personalized Medicine 52 Figure 3.2: Impact of Diagnostic Testing on Healthcare Decision-Making 52 Figure 3.3: Impact of Diagnostic Testing on Healthcare Spending 53 Figure 3.4: Breakout of the Molecular Diagnostics Marketplace 54 Figure 3.5: Molecular Diagnostics Market Segmentation 55 Figure 3.6: Molecular Diagnostics Market Segmentation by Technology 55 Figure 3.7: Market Survey Respondent Demographics 60 Figure 3.8: Breakout of the Respondent Pool by Affiliation 60 Figure 3.9: Segmentation of the Personalized Medicine Market 61 Figure 4.1: Personalized Medicine Market Drivers 63 Figure 4.2: Challenges in the Personalized Medicine Space 64 Figure 5.1: Carcinogenesis is a Multi-Step Process 72 Figure 5.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 79 Figure 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 79 Figure 7.1: Epigenomics Product Development Pipeline 163 INDEX OF TABLES Table 2.1: Timeline for Development of Companion Diagnostics 19 Table 2.2: Personalized Medicine at the Nexus Point 20 Table 2.3: Percentage of Non-Responders in Various Drug Classes 21 Table 2.4: High-Profile Drug Withdrawals from the Marketplace 21 Table 2.5: Metabolism of Drugs by Hepatic Enzymes 23 Table 2.6: Drug Metabolism Drives Drug Efficacy/Toxicity 25 Table 2.7: Population Frequency of the Various Cytochromes 26 Table 2.8: Selected List of Personalized Medicine Tests 28 Table 2.9: Personalized Medicine and Companion Diagnostics Product Pipeline 30 Table 2.10: Typical Response Rates in Therapeutic Areas 42 Table 2.11: Prevalence of People Taking Medications Metabolized by Liver Enzymes 43 Table 2.12: UGT1A1 Helps to Determine Risks Associated with Irinotecan 45 Table 2.13: Current Product Labels: Enzyme Metabolism 45 Table 3.1: Timeline for Impact of Various Molecular Diagnostics Technologies on Personalized Medicine 56 Table 3.2: Impact of Molecular Diagnostics Technologies on Therapeutic Areas in Personalized Medicine 56 Table 3.3: Challenges of Various Molecular Diagnostics Technology Platforms in Personalized Medicine 57 Table 3.4: FDA Classification of Diagnostics by Risk 59 Table 4.1: Personalized Medicine Industry SWOT Analysis 62 Table 4.2: Market Opportunities in Personalized Medicine 65 Table 4.3: Challenges for Market Adoption of Various Personalized Medicine Tests 66 Table 4.4: Hurdles to Personalized Medicine and Companion Diagnostics Development 67 Table 4.5: Timeline of Impact in Areas of Personalized Medicine 68 Table 4.6: Impact of Personalized Medicine on Various Therapeutic Areas 69 Table 5.1: Potential Benefits of Biomarkers as Companion Diagnostics 74 Table 5.2: Utility of Biomarker as Companion Diagnostics to Drug Development 74 Table 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results 78 Table 5.4: Device Submission Elements for the FDA 87 Table 6.1: List and Discounted Prices for Abbott Tumor Marker Tests 95 Table 6.2: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics 123 Table 6.3: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests 123 Table 7.1: Major Players in Companion Diagnostics Sector 127 Table 7.2: Opportunities for Biomarkers in Cancer Diagnosis and Treatment 152 Table 7.3: Tumor Diagnosis Immunoassay 161 Table 7.4: Tumor Diagnosis Radioimmunoassay 162 Table 7.5: Summary of Matritech's Product Development Programs 179 Companies Mentioned - 20/20 GeneSystems - Abbott Diagnostics - Affymetrix - Agendia BV - Agensys - Almac Group - AMDL - Arcturus Bioscience - Aureon Biosciences - Beckman Coulter - Biocode S.A. - BioCurex - Biomarker Technologies - Biomedical Diagnostics - Biomerica - bioM?rieux - Biomira - BioModa - Bruker Daltonics - Byk Gulden - Cangen Biotechnologies - Caprion Proteomics - Celera Diagnostics - Cepheid - Claros Diagnostics - Clinical Data: PGxHealth and Cogenics - Ciphergen Biosystems - Clarient - Correlogic Systems - Cytogen - Cytyc Corporation - Dako - DiaDexus LLC - Digene Corporation - DiagnoCure - Diagnostic Systems Laboratories - DRG International - DxS - EDP Biotech - Epigenomics - Exact Sciences Corporation - Exagen Diagnostics - Gene Logic - Genesis Genomics - Genomic Health - Gen-Probe - Health Discovery Corporation - Ikonisys - Immunicon - Immunomedics - Incyte Pharmaceuticals - InterGenetics - Ipsogen - LabCorp - Matritech - Miraculins - Mitsubishi Kagaku Medical - Molecular Diagnostics (CytoCore) - Monogram Biosciences - Myriad Genetics - NimbleGen Systems - Northwest Biotherapeutics - Oncotech - Orion Genomics - Oxford Genome Sciences - Panacea Pharmaceuticals - Perlegen Sciences - Polymedco - Power3 Medical Products - Prometheus - Proteome Systems - Qiagen - Sanko Junyaku - SensiGen - SuperArray Bioscience - Third Wave Technologies - Tosoh Medics - TrimGen - TriPath Imaging - Upstream Biosciences - Ventana Medical Systems - Veridex For more information visit http://www.researchandmarkets.com/research/35n4zz/companion About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. 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Eisai Receives European Commission Approval of Indication Expansion for Anticancer Agent Halaven for Advanced Breast Cancer After Only One Prior Chemotherapy
JCN Newswire - Thu Jul 03, 7:58PM CDT
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai" announced today that it has received approval from the European Commission of the indication expansion of Halaven (generic name: eribulin mesylate, "eribulin" to contribute to earlier treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments.
Eisai to Launch First Chocola BB Brand Product "Chocola BB Royal Drink" in China
JCN Newswire - Wed Jul 02, 5:46AM CDT
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai" announced today that it has launched its Chocola BB Royal Drink in China. This marks the first Chocola BB series product launched in China by Eisai.
Boston Strategics Corporation Announces Licensing Deal with Eisai Co., Ltd.
Business Wire - Mon Jun 30, 2:42PM CDT
Boston Strategics Corporation (BSC), an integrated clinical-stage drug research and development (R&D) company, Boston, MA, today announced that it has entered into an exclusive licensing and development agreement with Japanese global pharmaceutical company Eisai Co., Ltd., for Eisai's oncology drug, E6201.
Barry Lederman Appointed Vice President and Chief Financial Officer of Eisai Inc.
PR Newswire - Mon Jun 23, 7:30AM CDT
Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announces the immediate appointment of Barry Lederman to the position of Vice President and Chief Financial Officer (CFO). In this role, Mr. Lederman will have full oversight and responsibility for leading Eisai's financial operations in the Americas Region. He also will serve as a member of the company's Executive Committee.
Onychomycosis (Tinea Unguium) - Pipeline Review, H1 2014
M2 - Thu Jun 12, 3:09AM CDT
Research and Markets (http://www.researchandmarkets.com/research/zp6w5m/onychomycosis) has announced the addition of the "Onychomycosis (Tinea Unguium) - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Onychomycosis (Tinea Unguium), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Onychomycosis (Tinea Unguium) and special features on late-stage and discontinued projects. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Scope - The report provides a snapshot of the global therapeutic landscape of Onychomycosis (Tinea Unguium) - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Onychomycosis (Tinea Unguium) and enlists all their major and minor projects Companies Mentioned: - Actavis plc - Eisai Co., Ltd. - Nihon Nohyaku Co., Ltd. - Helix BioMedix, Inc. - Kaken Pharmaceutical Co., Ltd. - Apricus Biosciences, Inc. - NovaBay Pharmaceuticals, Inc. - Nuvo Research Inc. - Mayne Pharma Group Limited - Evolva SA - Novabiotics Ltd - Anacor Pharmaceuticals, Inc. - NB Therapeutics, Inc. - NanoBio Corporation - Moberg Pharma AB - Viamet Pharmaceuticals, Inc. - Celtic Pharmaceutical Holdings L.P. - Meiji Seika Pharma Co., Ltd. For more information visit http://www.researchandmarkets.com/research/zp...chomycosis
Global Alzheimer's Drugs Market 2012-2016 with H. Lundbeck A/S., Novartis AG and Pfizer Inc. Dominating
M2 - Mon Mar 31, 12:06PM CDT
Research and Markets (http://www.researchandmarkets.com/research/jffd8d/global) has announced the addition of the "Global Alzheimer's Drugs Market 2012-2016" report to their offering. The analysts forecast the Global Alzheimer's Drugs market to grow at a CAGR of 3.26 percent over the period 2012-2016. One of the key factors contributing to this market growth is the increasing aging population. The Global Alzheimer's Drugs market has also been witnessing the availability of improved diagnostics. However, numerous patent expiries could pose a challenge to the growth of this market. The key vendors dominating this market space include Eisai Co., Ltd., Forest Laboratories Inc., H. Lundbeck A/S., Novartis AG, and Pfizer Inc. The author recognizes the following companies as the key players in the Global Alzheimer's Drugs Market: Forest Laboratories Inc., Eisai Co. Ltd., Pfizer Inc., Novartis AG, and H. Lundbeck A/S. Commenting on the report, an analyst from the Healthcare team said: Clinical symptoms are usually observed long after the pathological processes of AD have begun. There are no definitive diagnostic tests for AD. Clinical diagnosis of AD primarily relies on subjective methods such as cognitive testing. There is a significant need for a reliable, cost-effective, and minimally-invasive test that could help in early diagnosis of AD. Various companies are engaged in the development of accurate and definitive diagnostic tests that could help in early diagnosis of the disease. Moreover, it is expected that the uptake of new drugs will be aided by the availability of improved diagnostics. For instance, the amyloid-binding agents for use with positron emission tomography imaging will help diagnose patients much earlier in the course of the disease. For more information visit http://www.researchandmarkets.com/research/jffd8d/global About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Eisai Assigns Its Worldwide Exclusive License for DACOGEN® to Otsuka
PR Newswire - Mon Mar 31, 1:30AM CDT
Eisai Inc., a subsidiary of Tokyo-based Eisai Co., Ltd., today announced the sale and assignment of its rights to a worldwide exclusive license for DACOGEN® (decitabine) for Injection to Otsuka Pharmaceutical Co., Ltd., giving Otsuka full development and commercialization rights for the product in the former Eisai territories of the United States, Canada and Japan. Eisai will retain its rights for DACOGEN® in Mexico.
Global Dermatological Drugs Market 2014-2018: The Global Dermatological Drugs Market is Expected to Reap Large Revenues with Increasing Use of Biologics
M2 - Wed Mar 26, 6:17AM CDT
Research and Markets (http://www.researchandmarkets.com/research/22gwrb/global) has announced the addition of the "Global Dermatological Drugs Market 2014-2018" report to their offering. The analysts forecast the Global Dermatological Drugs market to grow at a CAGR of 4.29 percent over the period 2013-2018. One of the key factors contributing to this market's growth is an increase in the aging population worldwide. The Global Dermatological Drugs market has also been witnessing a spurt in the use of biologics. However, the risk of adverse side effects associated with dermatological drugs could pose a challenge to the growth of this market. Key vendors dominating this space include AbbVie Inc., Galderma S.A., Johnson & Johnson Ltd., Novartis AG, Stiefel Laboratories Inc., and Valeant Pharmaceuticals International Inc. Other vendors mentioned in the report are Actavis plc, Allergan Inc., Almirall SA, Amgen Inc., Astellas Pharma Inc., AstraZeneca plc, Bayer AG, Bristol Myers Squibb Co., Celgene Corp., Eisai Co. Ltd., Eli Lilly and Co., Genentech Inc., Incyte Corp., Isotechnika Inc., LEO Pharma A/S, Merck & Co. Inc., Mylan Pharmaceuticals Inc., Pfizer Inc., and UCB SA. Commenting on the report, an analyst from the team said: Biologics are manufactured proteins interfering with the immune process involved in any dermatological disorders. In recent years, the enhanced understanding of the molecular basis underlying dermatological ailment led to the introduction of biological drugs, providing a new effective treatment option for dermatological disorders. Biologics emphasizes on specific aspects of the immune function that result in any illness. Along with topical treatments, the current market is crowded with biologics for dermatology. Amgen/Wyeth's Enbrel continues to hold its position as market leader amongst biologics; however, Abbott's Humira has increased its share significantly in the past year. For more information visit http://www.researchandmarkets.com/research/22gwrb/global About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Eisai Enters Collaboration With Liverpool School of Tropical Medicine And University of Liverpool To Discover Novel Anti-Wolbachia Targeted Anti-Filarial Drugs
PR Newswire - Thu Mar 20, 8:50AM CDT
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai " announced today that it has entered a collaboration with the Liverpool School of Tropical Medicine (Liverpool, United Kingdom, "LSTM " and University of Liverpool (Liverpool, United Kingdom, "UoL" to jointly identify new drugs effective against lymphatic filariasis and onchocerciasis (river blindness), both major types of filariasis.
Eisai Inc. Announces Retirement of President and CEO
PR Newswire - Mon Mar 10, 7:30AM CDT
Eisai Inc., a subsidiary of Tokyo-based Eisai Co., Ltd., today announced the appointments of Yuji Matsue as chairman and chief executive officer and Shaji Procida as president and chief operating officer, effective April 1, 2014. Mr. Matsue and Ms. Procida succeed current President and CEO Lonnel Coats, who will be retiring from Eisai in June 2014 after 18 years. Over the next few months, these executives will work closely to ensure a seamless management transition.
Arterial Thrombosis - Pipeline Review, H2 2013 Research Report
M2 - Mon Feb 24, 3:17AM CST
Research and Markets (http://www.researchandmarkets.com/research/f8f4ch/arterial) has announced the addition of the "Arterial Thrombosis - Pipeline Review, H2 2013" report to their offering. 'Arterial Thrombosis - Pipeline Review, H2 2013', provides an overview of the indication's therapeutic pipeline. This report provides information on the therapeutic development for Arterial Thrombosis, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Arterial Thrombosis. Scope - A snapshot of the global therapeutic scenario for Arterial Thrombosis. - A review of the Arterial Thrombosis products under development by companies and universities/research institutes based on information derived from company and industry-specific sources. - Coverage of products based on various stages of development ranging from discovery till registration stages. - A feature on pipeline projects on the basis of monotherapy and combined therapeutics. - Coverage of the Arterial Thrombosis pipeline on the basis of route of administration and molecule type. - Key discontinued pipeline projects. - Latest news and deals relating to the products. Key Topics Covered: List of Tables List of Figures Introduction Arterial Thrombosis Overview Therapeutics Development Pipeline Products for Arterial Thrombosis - Overview Late Stage Products Clinical Stage Products Early Stage Products Arterial Thrombosis - Products under Development by Companies Arterial Thrombosis - Therapeutics Assessment Drug Profiles ticagrelor - Drug Profile temanogrel hydrochloride - Drug Profile PZ-128 - Drug Profile BMS-593214 - Drug Profile ER-410660 - Drug Profile E-5539 - Drug Profile Arterial Thrombosis - Recent Pipeline Updates Arterial Thrombosis - Dormant Projects Arterial Thrombosis - Product Development Milestones Featured News & Press Releases List of Tables List of Figures Companies Mentioned Bristol-Myers Squibb Company AstraZeneca PLC Eisai Co., Ltd. Arena Pharmaceuticals, Inc. For more information visit http://www.researchandmarkets.com/research/f8f4ch/arterial About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Lorcaserin HCl Data to be Presented at the American Society of Bariatric Physicians' 64th Annual Obesity & Associated Conditions Symposium
PR Newswire - Wed Sep 10, 7:00AM CDT
Eisai Inc. and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announced today that data from the Phase 3 clinical trial program for BELVIQ® (lorcaserin HCl) CIV will be presented at the American Society of Bariatric Physicians' (ASBP) 64th Annual Obesity & Associated Conditions Symposium taking place September 10-13, 2014, in Austin, Texas.
Eisai Sells U.S. Rights to Zonegran® (zonisamide) Capsules to Concordia Pharmaceuticals Inc.
PR Newswire - Wed Sep 03, 6:00AM CDT
Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced it has entered into an agreement with Concordia Pharmaceuticals Inc. ("Concordia"
, a subsidiary of Concordia Healthcare Corp., to purchase Eisai's U.S. and Puerto Rican commercialization and distribution rights to Zonegran. As part of the deal terms, Eisai will receive full payment from Concordia upon closing. In addition, Eisai and Concordia are expected to enter into a supply agreement under which Eisai will serve as Concordia's supplier of Zonegran for the U.S. and Puerto Rican markets. Global Peptic Ulcer Drugs Market 2014-2018: Key Vendors are AstraZeneca, Eisai, Daewoong and Takeda
M2 - Fri Aug 29, 3:47AM CDT
Research and Markets (http://www.researchandmarkets.com/research/hx23pt/global_peptic) has announced the addition of the "Global Peptic Ulcer Drugs Market 2014-2018" report to their offering. A peptic ulcer is an open lesion that develops on the mucosal lining of the stomach and small intestine because of the caustic effect of the gastric acids and enzymes in these organs. The symptoms of peptic ulcers are pain in the abdomen, nausea, vomiting, and bloated stomach. The major symptoms include bleeding from the ulcer, which can be life-threatening. It is detected by bloody and sticky stools, often black in color. Peptic ulcers are caused mainly by a Helicobacter pylori infection followed by the overuse of OTC NSAIDs such as Naproxen, Aspirin and Ibuprofen. Peptic ulcers can be of two types based on the site of the ulcer: gastric ulcer and duodenal ulcer. The analysts forecast the Global Peptic Ulcer Drugs market to grow at a CAGR of 2.9 percent over the period 2013-2018. This report covers the present scenario and the growth prospects of the Global Peptic Ulcer Drugs market for the period 2014-2018. To calculate the market size, the report considers the revenue generated from the sales of various drugs used in the treatment of peptic ulcers that are available in the market. Key Topics Covered: 01. Executive Summary 02. List of Abbreviations 03. Scope of the Report 04. Product Profiles 05. Market Research Methodology 06. Introduction 07. Market Landscape 08. Pipeline Portfolio 09. Market Segmentation by Class of Drugs 10. Geographical Segmentation 11. Buying Criteria 12. Market Growth Drivers 13. Drivers and their Impact 14. Market Challenges 15. Impact of Drivers and Challenges 16. Market Trends 17. Trends and their Impact 18. Vendor Landscape 19. Key Vendor Analysis Companies Mentioned: - AstraZeneca plc - Eisai Co. Ltd. - Daewoong Pharmaceutical Co. Ltd. - Takeda Pharmaceutical Co. Ltd. - Daiichi Sankyo - Dr. Reddy's Laboratories - Eumedica - Ferring Pharmaceuticals - Horizon Pharma - Johnson and Johnson - Merck Sharp and Dohme - Otsuka Holdings - Pfizer - PharmaKing - Pozen - Rottapharm Madaus - Taiho Pharmaceutical - Zeria Pharmaceutical and Zuventus Healthcare For more information visit http://www.researchandmarkets.com/research/hx...bal_peptic
Eisai Submits Applications for Antiepilepsy Agent Fycompa Simultaneously In Europe and U.S.
JCN Newswire - Wed Aug 20, 1:21AM CDT
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"
announced today that it has submitted applications to regulatory authorities in the U.S. and Europe (the FDA and EMA respectively) for the indication expansion of its in-house developed antiepileptic drug Fycompa (generic name: perampanel) as an adjunctive treatment of primary generalized tonic-clonic seizures (PGTC). Eisai Supports Earthquake Relief Efforts in Yunnan, China
JCN Newswire - Wed Aug 06, 8:51PM CDT
Eisai expresses its heartfelt sympathies to all those affected by the recent earthquake which occurred in Ludian county of Zhaotong city, Yunnan province, China.
EMA Grants Eisai's Anticancer Agent Lenvatinib Request for Accelerated Assessment
JCN Newswire - Wed Jul 30, 9:48PM CDT
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"
announced today that its U.K. subsidiary Eisai Europe Ltd. has been granted an accelerated review by the European Medicines Agency (EMA) for its in-house developed anticancer agent lenvatinib mesylate ("lenvatinib" in the treatment of radioiodine-refractory differentiated thyroid cancer. Global Insomnia Clinical Trials Review, H2, 2014 Featuring 10 Companies & 10 Institutes
M2 - Thu Jul 17, 8:37AM CDT
Research and Markets (http://www.researchandmarkets.com/research/xplssq/insomnia_global) has announced the addition of the "Insomnia Global Clinical Trials Review, H2, 2014" report to their offering. Insomnia Global Clinical Trials Review, H2, 2014" provides data on the Insomnia clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Insomnia. It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Insomnia. Scope - Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations - Clinical trial (complete and in progress) data by phase, trial status, subjects recruited and sponsor type - Listings of discontinued trials (suspended, withdrawn and terminated) Clinical Trial Overview of Top Companies - Takeda Pharmaceutical Company Limited - Merck & Co., Inc. - Dainippon Sumitomo Pharma Co., Ltd. - Sanofi - Neurocrine Biosciences, Inc. - Pfizer Inc. - GlaxoSmithKline plc - Neurim Pharmaceuticals Ltd - Eisai Co., Ltd. - Actelion Ltd Clinical Trial Overview of Top Institutes / Government - University of Rochester - Duke University - U.S. Department of Veterans Affairs - Karolinska Institute - University of Pittsburgh - Brigham and Women's Hospital - Stanford University - The University of Hong Kong - Massachusetts General Hospital - National Institute of Mental Health For more information visit http://www.researchandmarkets.com/research/xp...nia_global
Global Alzheimer's Drugs Market 2014-2018 with Eisai Co. Forest Laboratories, Janssen Pharmaceuticals & Novartis Dominating
M2 - Fri Jul 11, 9:01AM CDT
Research and Markets (http://www.researchandmarkets.com/research/wldkgv/global) has announced the addition of the "Global Alzheimer's Drugs Market 2014-2018" report to their offering. The incidence rates for Alzheimer's disease are increasing, and the global Alzheimer's population is expected to double by 2030. Currently, it is estimated that 5 million Americans suffering from Alzheimer's disease are aged 65 years or above. This number might reach 13.8 million by 2050 as the baby boom generation ages. In the US, Alzheimer's disease is the fifth highest cause factor for deaths among people aged 65 years and above. It has been recognized as the only factor among the top 10 death-causing factors in America for which therapy is not available, preventing or slowing down the progression of disease. The number of deaths resulting from Alzheimer's disease increased by 68 percent during the period of 2000-2010 and this number is expected to increase further during the next decade. In the US, it is estimated that about 7,00,000 people aged 65 years or above will die from Alzheimer's disease in 2014. The incidence rate of Alzheimer's disease is increasing rapidly owing to a rise in the elderly population. In the US, the 2014 incidence rate of Alzheimer's disease for people aged 65 years or above is expected to reach 4,69,000 and this number is expected to double by 2050. According to the report, the Global Alzheimer's Drugs market is driven by several factors, of which the increase in the global aging population is one of the major drivers. The incidence of Alzheimer's disease is growing continuously, mainly because of an increase in the aging population, especially those aged 65 years or above. It is estimated about 596.8 million people will reach 65 years and above in 2014, and this number is expected to reach 681.2 million by 2018. Furthermore, the report states that one of the main challenges is the poor rate of Alzheimer's disease diagnosis. In developed economies, merely 20-50 percent of dementia cases are diagnosed while in developing economies such as India nearly 90 percent cases remain undiagnosed. The lack of diagnosis hampers the effective management of this disease. Key Vendors: - Eisai Co., Ltd. - Forest Laboratories Inc. - Janssen Pharmaceuticals Inc. - Novartis AG Other Prominent Vendors: - Adamas Pharmaceuticals Inc. - Archer Pharmaceuticals Inc. - Eli Lilly and Co. - F. Hoffmann-La Roche Ltd. - FORUM Pharmaceuticals Inc. - H. Lundbeck A/S - Merck & Co., Inc. - MorphoSys AG - Otsuka Pharmaceutical Development & Commercialization Inc./ Otsuka America Pharmaceutical, Inc. - Takeda Pharmaceutical Co., Ltd. - TauRx Pharmaceuticals Ltd. - Zinfandel Pharmaceuticals Inc. Key Topics Covered: - Executive Summary - List of Abbreviations - Scope of the Report - Market Research Methodology - Introduction - Disease Overview - Alzheimer's Disease - Market Landscape - Market Segmentation by MOA - Market Assessment of Top Drugs - Competitive Assessment of Top Drugs - Focus on Alzheimer's Research - Geographical Segmentation - Buying Criteria - Market Growth Drivers - Drivers and their Impact - Market Challenges - Impact of Drivers and Challenges - Market Trends - Trends and their Impact - Vendor Landscape - Future Vendors Expected To Tap the Market - Key Vendor Analysis For more information visit http://www.researchandmarkets.com/research/wldkgv/global
Companion Diagnostics in Personalized Medicine and Cancer Therapy
M2 - Mon Jul 07, 8:04AM CDT
Research and Markets (http://www.researchandmarkets.com/research/35n4zz/companion) has announced the addition of the "Companion Diagnostics in Personalized Medicine and Cancer Therapy" report to their offering. Companion diagnostics (CDx) refers to a particular clinical diagnostic test that is under evaluation and is specifically linked to a known drug therapy. This linkage could be important in the therapeutic application and clinical outcome of a drug, such as with personalized medicine for oncology patients. The molecular diagnostics field plays a vital part in personalized medicine and has greatly expanded over the past twenty years, expanding by more than 20% annually compared to most other laboratory procedures. Research will continue to produce an increased understanding of disease processes, and diagnostics manufacturers will continue to expand and refine the technology and automation needed for clinical testing. Companion diagnostics, although smaller at present, is one of the fastest growing segments in the in vitro diagnostic (IVD) market. And while the concept of a drug-diagnostic combination is not new, it has only recently started to generate interest with the move of healthcare towards pharmacogenomics. This TriMark Publications report examines the use of companion diagnostics in personalized medicine and cancer therapy. The study provides a qualitative and quantitative review of the industry, including cancer biomarker tests, pharmacogenomics tests, recurrence prediction tests, blood-based technologies, proteomics and regulatory trends. Moreover, this analysis profiles the leading companies that are developing and manufacturing companion diagnostics solutions. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market share data are also included. Key Topics Covered: 1. Overview 1.1 Statement of Report 1.2 About This Report 1.3 Scope of the Report 1.4 Objectives 1.5 Methodology 1.6 Executive Summary 2. Companion Diagnostics and Personalized Medicine 2.1 Scope of This Section 2.2 Introduction to Companion Diagnostics and Personalized Medicine 2.3 Drug Metabolism, Companion Diagnostics and Personalized Medicine 2.4 Examples of Personalized Medicine and Companion Diagnostic Tests 2.5 Personalized Medicine and Companion Diagnostic Testing Product Pipeline 2.6 The Personalized Medicine Coalition (PMC) 2.7 Regulatory Trends and Guidelines in the Personalized Medicine Space 2.7.1 The Changing Regulatory Landscape for Personalized Medicine 2.8 Companion Diagnostics Play an Increasing Role in Cancer Care 2.9 Specific Examples of Clinical Situations where Companion Diagnostics are being Deployed 2.9.1 Epidermal Growth Factor Receptor Assay 2.9.2 Individualized Warfarin Therapy 2.9.3 UGT1A1 Molecular Assay for Camptosar 2.9.4 Response to Gleevec in Gastrointestinal Stromal Tumors (GISTs) 2.9.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases 2.9.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Enter Companion Diagnostics 2.9.7 Roche's Metastatic Melanoma Treatment, Zelboraf (vemurafenib) 2.9.8 Abbott's Late-Stage NSCLC Treatment, Xalkori (crizotinib) 2.10 Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness 2.11 Value Chain 2.12 Impact of Companion Diagnostics/Personalized Medicine on Drug Clinical Trials 3. Companion Diagnostics: Qualitative and Quantitative Market Analysis 3.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics 3.2 Costs of Companion Diagnostics in Healthcare Expenditures 3.3 Molecular Diagnostic Market 3.4 Molecular Diagnostics Technology Platforms and Their Impact on Clinical Medicine 3.5 Snapshot of Companion Diagnostics Industry Structure 3.6 The Case for Theranostics 3.7 Companion Diagnostics Market Analysis Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters 4. Trends and Overview 4.1 Companion Diagnostics: Industry SWOT Analysis 4.2 Macro Trends in Companion Diagnostics 4.3 Challenges for Companion Diagnostics Development 4.4 Timeline for Impact of Various Segments in Companion Diagnostics 4.5 Use of Proteomics to Develop Individualized Tests 4.6 The Market Problem: Finding Value with Diagnostics for Personalized Medicine 5. Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics 5.1 Sector Overview 5.1.1 Impact of New Technology Platforms 5.1.2 Impact on Drug Discovery 5.1.3 Biomarkers as Endpoints in Drug Discovery 5.1.4 Targeted Therapy 5.2 Companion Diagnostics on the Market 5.3 Epidermal Growth Factor Receptor Companions 5.3.1 Bevacizamab (Avastin) 5.3.2 EGFR for CRC and Camptosar (Irinotecan) 5.3.2.1 Companion Diagnostic Test Developed for UGT1A1 for Irinotecan 5.3.2.2 Companion Diagnostic Test Developed for Bristol-Myers' SPRYCEL 5.3.3 EGFR Express and Erbitux (Cetuximab) 5.3.4 HER2 and Heceptin (Trastuzumab) 5.3.4.1 Bayer's Advia Centaur HER2/neu Assay 5.3.4.2 Companies Marketing HER2/neu Assays 5.3.5 Iressa and Tarceva Companion Test 5.3.6 Tykerb (GlaxoSmithKline (GSK)) and Vectibix (Amgen) Companion Tests 5.3.7 EGFRx Assay 5.3.8 Monogram eTag 5.3.9 Veripath OncoDiagnostics EGFR PharmDX 5.3.10 NSCLC Patients with EGFR Mutation 5.3.11 A Personalized Medicine Program for CML 5.4 Companions Based on Myriad's IVDMIA Technology 5.4.1 Myriad's TheraGuide 5-FU 5.4.2 Myriad's BRCA Companion Diagnostics Testing for BioMarin's PARP Inhibitor BMN 673 5.5 Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib 5.5.1 TheraScreen: EGFR29 5.5.2 The K-RAS Mutation Detection Kit 5.6 Irinotecan and UGT1A1 5.7 Gleevec (Imatinib) Companions 5.7.1 DakoCytomation's c-Kit (9.7) pharmDx 5.8 Companion Diagnostics Involving Metabolizing Enzymes 5.8.1 Companions for TMPT, CYP2C9 and UGT1A1 Enzymes 5.8.2 Companions for Aromatase Inhibitors 5.8.3 Companions for Actos and Avandia 5.9 Drivers and Barriers to Companion Diagnostics 5.10 Partnerships with Pharma Companies to Identify Therapeutic Targets 5.11 Circulating Tumor Cell Assay: Prognostic and Predictive Factors for Breast Cancer 5.12 Companion Diagnostics Used by Clinical Service Laboratories 5.13 New Technologies and Products under Development 5.13.1 OncoMethylome (now MDx Health) 5.13.2 Ventana Medical Systems Inks Companion Diagnostic Deal with Syndax for Lung Cancer Drug 5.13.3 Abbott Expands Agreement with GSK to Include Development of a Companion Diagnostic Test for the PRAME Antigen 5.14 Pharmacogenomics Tests 5.14.1 MGMT Methylation Assay 5.14.2 Other Pharmacogenomic Opportunities 5.15 Recurrence Prediction Tests 5.16 Blood-based Technologies 5.16.1 Oncotech 5.17 Monogram Biosciences HIV Personalized Platform 5.18 Wako LBA\AFP Test for Liver Cancer 5.19 Future Developments for Companion Diagnostics 5.20 Drug Response Predictors 6. Business and Regulatory Trends in the Companion Biomarker Testing Sector 6.1 Industry Consolidation 6.2 Breath of Product Offering and Pricing 6.3 Government Regulation of Medical Devices 6.3.1 FDA Guidance on Drug Test Co-development 6.3.2 Device Classes 6.3.3 Investigational Use of IVDMIAs 6.3.4 Post-market Requirements 6.3.5 Voluntary versus Required Submissions 6.3.6 Examples of Recent Voluntary Genomic Data Submissions 6.3.7 FDA Labeling Implications and Rules 6.3.8 Regulatory Activities in Companion Diagnostic Testing Translation of Diagnostic Testing Results into Clinical Practice 6.4 Strategic Business and Marketing Considerations 6.5 Commercial Opportunities in Companion Markers 6.6 Moderators of Growth 6.6.1 Roadblocks to Integrating Companion Biomarkers into Clinical Practice 6.6.2 Management of Targeted Therapeutics by Third-Party Payers 6.7 Biotechnology Industry Trends 6.8 Pharmaceutical Industry Trends 6.9 Acquisition, License Agreement, Partnerships 6.10 Legal Developments 6.11 Sales and Marketing Strategies for Tumor Marker Tests 6.11.1 International Markets 6.11.2 Europe 6.11.3 Central and South America 6.11.4 Asia-Pacific 6.12 Product Commercialization 6.13 Reimbursement 6.14 Self-Referral Rules 6.15 Health Insurance Portability and Accountability Act 6.16 Clinical Laboratory Improvement Amendments (CLIA) 6.17 In Vitro Diagnostic Directive (IVDD) and Medical Device Regulations 6.18 FDA's Quality System Regulation (QSR) 6.19 The FDA's OIVD on IVDMIAs 6.20 FDA's Qualification of Cancer Biomarkers 6.20.1 Regulatory Perspectives of Biomarker Validation 6.21 Genetic Tests and Medical Records 6.21.1 Laws against Genetic Discrimination 6.22 Global Drivers of Clinical Laboratory Testing 6.23 Global Outlook 6.24 Oncology Biomarker Qualification Initiative 6.25 FDA Critical Path 6.25.1 Examples of Drugs being Hindered due to Lack of Compliance with FDA Directives 6.26 Biomarkers and FDA's Voluntary Genomic Data Submission 6.27 From Personalized to Predictive Medicine 6.28 Analysis of Cost-Effectiveness at the Individual Level 6.29 The Patient and Advocate Perspective: An Evolution of Influence 6.30 Real-World Experiences Translating the Vision of Personalized Medicine into Practice 6.30.1 Evolving Business Models in Companion Diagnostics and Personalized Medicine 6.30.2 Current Pharma/Diagnostics Business Model Examples 6.31 Reimbursement and Value Creation 6.32 What is the Role of Governmental Agencies in Driving the Adoption of Companion Diagnostics? 6.33 What is the Role of the Insurance Industry in Driving the Adoption of pharmacogenomics (PGx)? 6.34 What is the Role of the Pharma Industry in Driving the Adoption of PGx? 6.35 FDA Guidance Document on Co-development 6.36 What is the Role of the Diagnostic Industry in Driving the Adoption of PGx? 6.37 What is the Future Role of PBMs in Laboratory Services? 7. Companies Entering the Companion Diagnostics Market 7.1 Industry Overview 7.1.1 20/20 GeneSystems, Inc. 7.1.2 Abbott Molecular, Inc. 7.1.3 Affymetrix, Inc. 7.1.4 Agendia BV 7.1.5 Agensys, Inc. 7.1.6 Agilent Technologies 7.1.7 Almac Group 7.1.8 AMDL, Inc. 7.1.9 Applied Biosystems 7.1.10 Asuragen, Inc. 7.1.11 Aureon Laboratories Corporation 7.1.12 Beckman Coulter, Inc. 7.1.13 Becton, Dickinson and Company (BD) Diagnostics - TriPath 7.1.14 Biocode Hycel 7.1.15 BioCurex, Inc. 7.1.16 Biodesix 7.1.17 Biomarker Technologies, LLC 7.1.18 Biomedical Diagnostics, LLC 7.1.19 Biomerica 7.1.20 bioM?rieux, Inc. 7.1.21 Biomira, Inc. 7.1.22 BioModa, Inc. 7.1.23 Bruker Daltonics 7.1.24 Byk Gulden 7.1.25 Cangen Biotechnologies, Inc. 7.1.26 Caprion Proteomics 7.1.27 Celera Diagnostics 7.1.28 Cepheid, Inc. 7.1.29 Clarient, Inc. 7.1.30 Claros Diagnostics 7.1.31 Clinical Data, Inc.: PGxHealth and Cogenics 7.1.32 Correlogic Systems, Inc. 7.1.33 CytoCore, Inc. (Formerly Known As Molecular Diagnostics, Inc.) 7.1.34 Cytogen Corporation (now EUSA Pharma) 7.1.35 Dako (Formerly DakoCytomation) 7.1.36 DiaDexus 7.1.37 DiagnoCure 7.1.38 DRG International 7.1.39 EDP Biotech Corporation 7.1.40 Eisai Co., Ltd. 7.1.41 Epigenomics 7.1.42 EXACT Sciences Corporation 7.1.43 Exagen Diagnostics 7.1.44 Gene Logic, Inc. 7.1.45 Genesis Genomics, Inc. (now known as Mitomics) 7.1.46 GenMark Diagnostics 7.1.47 Genomic Health 7.1.48 Gen-Probe, Inc. 7.1.49 Health Discovery Corporation 7.1.50 Hologic, Inc. (Formerly Cytyc Corporation) 7.1.51 Ikonisys, Inc. 7.1.52 Illumina 7.1.53 Immunomedics 7.1.54 Incyte 7.1.55 InterGenetics 7.1.56 Ipsogen 7.1.57 Johnson & Johnson 7.1.58 LabCorp 7.1.59 Life Technologies Corporation 7.1.60 Matritech, Inc. 7.1.61 Miraculins 7.1.62 Mitsubishi Kagaku latron 7.1.63 Monogram Biosciences (formerly ViroLogic Inc.) 7.1.64 Myriad Genetics, Inc. 7.1.65 NimbleGen Systems 7.1.66 Northwest Biotherapeutics, Inc. 7.1.67 Novartis MDx 7.1.68 Nycomed 7.1.69 Oncotech, Inc. 7.1.70 Oncothyreon, Inc. (Formerly known as Biomira) 7.1.71 Orion Genomics 7.1.72 Oxford BioTherapeutics (formerly Oxford Genome Sciences) 7.1.73 Panacea Pharmaceuticals, Inc. 7.1.74 Polymedco, Inc. 7.1.75 Power3 Medical Products 7.1.76 Prometheus 7.1.77 Proteome Systems Limited 7.1.78 Qiagen N.V. 7.1.79 Roche Molecular Diagnostics 7.1.80 Sanko Junyaku Co. Ltd. 7.1.81 SensiGen, LLC 7.1.82 Siemens Healthcare Diagnostics, Inc. 7.1.83 SuperArray Bioscience Corporation 7.1.84 Third Wave Technologies, Inc. (now owned by Hologic) 7.1.85 Tosoh Biosciences 7.1.86 TrimGen 7.1.87 Upstream Biosciences, Inc. 7.1.88 Ventana Medical Systems, Inc. 7.1.89 Veridex, LLC 7.1.90 Vermillion, Inc. (Formerly Ciphergen) 7.1.91 Vertex Pharmaceuticals, Inc. Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submissions A1.1 Introduction A1.2 Background A1.3 Submission Policy A1.3.1 General Principles A1.3.2 Specific Uses of Pharmacogenomic Data in Drug Development and Labeling A1.3.3 Benefits of Voluntary Submissions to Sponsors and FDA A1.4 Submission of Pharmacogenomic Data A1.4.1 Submission of Pharmacogenomic Data During the IND Phase A1.4.2 Submission of Pharmacogenomic Data to a New NDA, BLA or Supplement A1.4.3 Submission to a Previously Approved NDA or BLA A1.4.4 Compliance with 21 CFR Part 58 A1.4.5 Submission of Voluntary Genomic Data from Application-Independent Research A1.5 Format and Content of a VGDS A1.6 Process for Submitting Pharmacogenomic Data A1.7 Agency Review of VGDSs Appendix 2: FDA Issues Draft Companion Diagnostic Guidance Appendix 3: Histochemical Markers for Cancer Glossary INDEX OF FIGURES Figure 2.1: Personalizing Drug Treatment 18 Figure 2.2: Approaches to Personalized Medicine 19 Figure 2.3: The Phase I and II Processes of Drug Metabolism 22 Figure 2.4: Hepatic Distribution of Human CYP450 23 Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism 24 Figure 2.6: Genetic Components Determine Drug Metabolism 24 Figure 2.7: Personalized Medicine Drugs in Development 29 Figure 2.8: Healthcare Value Chain 49 Figure 3.1: From Genetic Content to Personalized Medicine 52 Figure 3.2: Impact of Diagnostic Testing on Healthcare Decision-Making 52 Figure 3.3: Impact of Diagnostic Testing on Healthcare Spending 53 Figure 3.4: Breakout of the Molecular Diagnostics Marketplace 54 Figure 3.5: Molecular Diagnostics Market Segmentation 55 Figure 3.6: Molecular Diagnostics Market Segmentation by Technology 55 Figure 3.7: Market Survey Respondent Demographics 60 Figure 3.8: Breakout of the Respondent Pool by Affiliation 60 Figure 3.9: Segmentation of the Personalized Medicine Market 61 Figure 4.1: Personalized Medicine Market Drivers 63 Figure 4.2: Challenges in the Personalized Medicine Space 64 Figure 5.1: Carcinogenesis is a Multi-Step Process 72 Figure 5.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC 79 Figure 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH 79 Figure 7.1: Epigenomics Product Development Pipeline 163 INDEX OF TABLES Table 2.1: Timeline for Development of Companion Diagnostics 19 Table 2.2: Personalized Medicine at the Nexus Point 20 Table 2.3: Percentage of Non-Responders in Various Drug Classes 21 Table 2.4: High-Profile Drug Withdrawals from the Marketplace 21 Table 2.5: Metabolism of Drugs by Hepatic Enzymes 23 Table 2.6: Drug Metabolism Drives Drug Efficacy/Toxicity 25 Table 2.7: Population Frequency of the Various Cytochromes 26 Table 2.8: Selected List of Personalized Medicine Tests 28 Table 2.9: Personalized Medicine and Companion Diagnostics Product Pipeline 30 Table 2.10: Typical Response Rates in Therapeutic Areas 42 Table 2.11: Prevalence of People Taking Medications Metabolized by Liver Enzymes 43 Table 2.12: UGT1A1 Helps to Determine Risks Associated with Irinotecan 45 Table 2.13: Current Product Labels: Enzyme Metabolism 45 Table 3.1: Timeline for Impact of Various Molecular Diagnostics Technologies on Personalized Medicine 56 Table 3.2: Impact of Molecular Diagnostics Technologies on Therapeutic Areas in Personalized Medicine 56 Table 3.3: Challenges of Various Molecular Diagnostics Technology Platforms in Personalized Medicine 57 Table 3.4: FDA Classification of Diagnostics by Risk 59 Table 4.1: Personalized Medicine Industry SWOT Analysis 62 Table 4.2: Market Opportunities in Personalized Medicine 65 Table 4.3: Challenges for Market Adoption of Various Personalized Medicine Tests 66 Table 4.4: Hurdles to Personalized Medicine and Companion Diagnostics Development 67 Table 4.5: Timeline of Impact in Areas of Personalized Medicine 68 Table 4.6: Impact of Personalized Medicine on Various Therapeutic Areas 69 Table 5.1: Potential Benefits of Biomarkers as Companion Diagnostics 74 Table 5.2: Utility of Biomarker as Companion Diagnostics to Drug Development 74 Table 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results 78 Table 5.4: Device Submission Elements for the FDA 87 Table 6.1: List and Discounted Prices for Abbott Tumor Marker Tests 95 Table 6.2: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics 123 Table 6.3: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests 123 Table 7.1: Major Players in Companion Diagnostics Sector 127 Table 7.2: Opportunities for Biomarkers in Cancer Diagnosis and Treatment 152 Table 7.3: Tumor Diagnosis Immunoassay 161 Table 7.4: Tumor Diagnosis Radioimmunoassay 162 Table 7.5: Summary of Matritech's Product Development Programs 179 Companies Mentioned - 20/20 GeneSystems - Abbott Diagnostics - Affymetrix - Agendia BV - Agensys - Almac Group - AMDL - Arcturus Bioscience - Aureon Biosciences - Beckman Coulter - Biocode S.A. - BioCurex - Biomarker Technologies - Biomedical Diagnostics - Biomerica - bioM?rieux - Biomira - BioModa - Bruker Daltonics - Byk Gulden - Cangen Biotechnologies - Caprion Proteomics - Celera Diagnostics - Cepheid - Claros Diagnostics - Clinical Data: PGxHealth and Cogenics - Ciphergen Biosystems - Clarient - Correlogic Systems - Cytogen - Cytyc Corporation - Dako - DiaDexus LLC - Digene Corporation - DiagnoCure - Diagnostic Systems Laboratories - DRG International - DxS - EDP Biotech - Epigenomics - Exact Sciences Corporation - Exagen Diagnostics - Gene Logic - Genesis Genomics - Genomic Health - Gen-Probe - Health Discovery Corporation - Ikonisys - Immunicon - Immunomedics - Incyte Pharmaceuticals - InterGenetics - Ipsogen - LabCorp - Matritech - Miraculins - Mitsubishi Kagaku Medical - Molecular Diagnostics (CytoCore) - Monogram Biosciences - Myriad Genetics - NimbleGen Systems - Northwest Biotherapeutics - Oncotech - Orion Genomics - Oxford Genome Sciences - Panacea Pharmaceuticals - Perlegen Sciences - Polymedco - Power3 Medical Products - Prometheus - Proteome Systems - Qiagen - Sanko Junyaku - SensiGen - SuperArray Bioscience - Third Wave Technologies - Tosoh Medics - TrimGen - TriPath Imaging - Upstream Biosciences - Ventana Medical Systems - Veridex For more information visit http://www.researchandmarkets.com/research/35n4zz/companion About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Eisai Receives European Commission Approval of Indication Expansion for Anticancer Agent Halaven for Advanced Breast Cancer After Only One Prior Chemotherapy
JCN Newswire - Thu Jul 03, 7:58PM CDT
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"
announced today that it has received approval from the European Commission of the indication expansion of Halaven (generic name: eribulin mesylate, "eribulin" to contribute to earlier treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments. Eisai to Launch First Chocola BB Brand Product "Chocola BB Royal Drink" in China
JCN Newswire - Wed Jul 02, 5:46AM CDT
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai"
announced today that it has launched its Chocola BB Royal Drink in China. This marks the first Chocola BB series product launched in China by Eisai. Boston Strategics Corporation Announces Licensing Deal with Eisai Co., Ltd.
Business Wire - Mon Jun 30, 2:42PM CDT
Boston Strategics Corporation (BSC), an integrated clinical-stage drug research and development (R&D) company, Boston, MA, today announced that it has entered into an exclusive licensing and development agreement with Japanese global pharmaceutical company Eisai Co., Ltd., for Eisai's oncology drug, E6201.
Barry Lederman Appointed Vice President and Chief Financial Officer of Eisai Inc.
PR Newswire - Mon Jun 23, 7:30AM CDT
Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announces the immediate appointment of Barry Lederman to the position of Vice President and Chief Financial Officer (CFO). In this role, Mr. Lederman will have full oversight and responsibility for leading Eisai's financial operations in the Americas Region. He also will serve as a member of the company's Executive Committee.
Onychomycosis (Tinea Unguium) - Pipeline Review, H1 2014
M2 - Thu Jun 12, 3:09AM CDT
Research and Markets (http://www.researchandmarkets.com/research/zp6w5m/onychomycosis) has announced the addition of the "Onychomycosis (Tinea Unguium) - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Onychomycosis (Tinea Unguium), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Onychomycosis (Tinea Unguium) and special features on late-stage and discontinued projects. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis. The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products. Scope - The report provides a snapshot of the global therapeutic landscape of Onychomycosis (Tinea Unguium) - The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities - The report reviews key players involved in the therapeutics development for Onychomycosis (Tinea Unguium) and enlists all their major and minor projects Companies Mentioned: - Actavis plc - Eisai Co., Ltd. - Nihon Nohyaku Co., Ltd. - Helix BioMedix, Inc. - Kaken Pharmaceutical Co., Ltd. - Apricus Biosciences, Inc. - NovaBay Pharmaceuticals, Inc. - Nuvo Research Inc. - Mayne Pharma Group Limited - Evolva SA - Novabiotics Ltd - Anacor Pharmaceuticals, Inc. - NB Therapeutics, Inc. - NanoBio Corporation - Moberg Pharma AB - Viamet Pharmaceuticals, Inc. - Celtic Pharmaceutical Holdings L.P. - Meiji Seika Pharma Co., Ltd. For more information visit http://www.researchandmarkets.com/research/zp...chomycosis
Global Alzheimer's Drugs Market 2012-2016 with H. Lundbeck A/S., Novartis AG and Pfizer Inc. Dominating
M2 - Mon Mar 31, 12:06PM CDT
Research and Markets (http://www.researchandmarkets.com/research/jffd8d/global) has announced the addition of the "Global Alzheimer's Drugs Market 2012-2016" report to their offering. The analysts forecast the Global Alzheimer's Drugs market to grow at a CAGR of 3.26 percent over the period 2012-2016. One of the key factors contributing to this market growth is the increasing aging population. The Global Alzheimer's Drugs market has also been witnessing the availability of improved diagnostics. However, numerous patent expiries could pose a challenge to the growth of this market. The key vendors dominating this market space include Eisai Co., Ltd., Forest Laboratories Inc., H. Lundbeck A/S., Novartis AG, and Pfizer Inc. The author recognizes the following companies as the key players in the Global Alzheimer's Drugs Market: Forest Laboratories Inc., Eisai Co. Ltd., Pfizer Inc., Novartis AG, and H. Lundbeck A/S. Commenting on the report, an analyst from the Healthcare team said: Clinical symptoms are usually observed long after the pathological processes of AD have begun. There are no definitive diagnostic tests for AD. Clinical diagnosis of AD primarily relies on subjective methods such as cognitive testing. There is a significant need for a reliable, cost-effective, and minimally-invasive test that could help in early diagnosis of AD. Various companies are engaged in the development of accurate and definitive diagnostic tests that could help in early diagnosis of the disease. Moreover, it is expected that the uptake of new drugs will be aided by the availability of improved diagnostics. For instance, the amyloid-binding agents for use with positron emission tomography imaging will help diagnose patients much earlier in the course of the disease. For more information visit http://www.researchandmarkets.com/research/jffd8d/global About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Eisai Assigns Its Worldwide Exclusive License for DACOGEN® to Otsuka
PR Newswire - Mon Mar 31, 1:30AM CDT
Eisai Inc., a subsidiary of Tokyo-based Eisai Co., Ltd., today announced the sale and assignment of its rights to a worldwide exclusive license for DACOGEN® (decitabine) for Injection to Otsuka Pharmaceutical Co., Ltd., giving Otsuka full development and commercialization rights for the product in the former Eisai territories of the United States, Canada and Japan. Eisai will retain its rights for DACOGEN® in Mexico.
Global Dermatological Drugs Market 2014-2018: The Global Dermatological Drugs Market is Expected to Reap Large Revenues with Increasing Use of Biologics
M2 - Wed Mar 26, 6:17AM CDT
Research and Markets (http://www.researchandmarkets.com/research/22gwrb/global) has announced the addition of the "Global Dermatological Drugs Market 2014-2018" report to their offering. The analysts forecast the Global Dermatological Drugs market to grow at a CAGR of 4.29 percent over the period 2013-2018. One of the key factors contributing to this market's growth is an increase in the aging population worldwide. The Global Dermatological Drugs market has also been witnessing a spurt in the use of biologics. However, the risk of adverse side effects associated with dermatological drugs could pose a challenge to the growth of this market. Key vendors dominating this space include AbbVie Inc., Galderma S.A., Johnson & Johnson Ltd., Novartis AG, Stiefel Laboratories Inc., and Valeant Pharmaceuticals International Inc. Other vendors mentioned in the report are Actavis plc, Allergan Inc., Almirall SA, Amgen Inc., Astellas Pharma Inc., AstraZeneca plc, Bayer AG, Bristol Myers Squibb Co., Celgene Corp., Eisai Co. Ltd., Eli Lilly and Co., Genentech Inc., Incyte Corp., Isotechnika Inc., LEO Pharma A/S, Merck & Co. Inc., Mylan Pharmaceuticals Inc., Pfizer Inc., and UCB SA. Commenting on the report, an analyst from the team said: Biologics are manufactured proteins interfering with the immune process involved in any dermatological disorders. In recent years, the enhanced understanding of the molecular basis underlying dermatological ailment led to the introduction of biological drugs, providing a new effective treatment option for dermatological disorders. Biologics emphasizes on specific aspects of the immune function that result in any illness. Along with topical treatments, the current market is crowded with biologics for dermatology. Amgen/Wyeth's Enbrel continues to hold its position as market leader amongst biologics; however, Abbott's Humira has increased its share significantly in the past year. For more information visit http://www.researchandmarkets.com/research/22gwrb/global About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
Eisai Enters Collaboration With Liverpool School of Tropical Medicine And University of Liverpool To Discover Novel Anti-Wolbachia Targeted Anti-Filarial Drugs
PR Newswire - Thu Mar 20, 8:50AM CDT
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai "
announced today that it has entered a collaboration with the Liverpool School of Tropical Medicine (Liverpool, United Kingdom, "LSTM " and University of Liverpool (Liverpool, United Kingdom, "UoL" to jointly identify new drugs effective against lymphatic filariasis and onchocerciasis (river blindness), both major types of filariasis. Eisai Inc. Announces Retirement of President and CEO
PR Newswire - Mon Mar 10, 7:30AM CDT
Eisai Inc., a subsidiary of Tokyo-based Eisai Co., Ltd., today announced the appointments of Yuji Matsue as chairman and chief executive officer and Shaji Procida as president and chief operating officer, effective April 1, 2014. Mr. Matsue and Ms. Procida succeed current President and CEO Lonnel Coats, who will be retiring from Eisai in June 2014 after 18 years. Over the next few months, these executives will work closely to ensure a seamless management transition.
Arterial Thrombosis - Pipeline Review, H2 2013 Research Report
M2 - Mon Feb 24, 3:17AM CST
Research and Markets (http://www.researchandmarkets.com/research/f8f4ch/arterial) has announced the addition of the "Arterial Thrombosis - Pipeline Review, H2 2013" report to their offering. 'Arterial Thrombosis - Pipeline Review, H2 2013', provides an overview of the indication's therapeutic pipeline. This report provides information on the therapeutic development for Arterial Thrombosis, complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Arterial Thrombosis. Scope - A snapshot of the global therapeutic scenario for Arterial Thrombosis. - A review of the Arterial Thrombosis products under development by companies and universities/research institutes based on information derived from company and industry-specific sources. - Coverage of products based on various stages of development ranging from discovery till registration stages. - A feature on pipeline projects on the basis of monotherapy and combined therapeutics. - Coverage of the Arterial Thrombosis pipeline on the basis of route of administration and molecule type. - Key discontinued pipeline projects. - Latest news and deals relating to the products. Key Topics Covered: List of Tables List of Figures Introduction Arterial Thrombosis Overview Therapeutics Development Pipeline Products for Arterial Thrombosis - Overview Late Stage Products Clinical Stage Products Early Stage Products Arterial Thrombosis - Products under Development by Companies Arterial Thrombosis - Therapeutics Assessment Drug Profiles ticagrelor - Drug Profile temanogrel hydrochloride - Drug Profile PZ-128 - Drug Profile BMS-593214 - Drug Profile ER-410660 - Drug Profile E-5539 - Drug Profile Arterial Thrombosis - Recent Pipeline Updates Arterial Thrombosis - Dormant Projects Arterial Thrombosis - Product Development Milestones Featured News & Press Releases List of Tables List of Figures Companies Mentioned Bristol-Myers Squibb Company AstraZeneca PLC Eisai Co., Ltd. Arena Pharmaceuticals, Inc. For more information visit http://www.researchandmarkets.com/research/f8f4ch/arterial About Research and Markets Research and Markets is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
