Immunomedics (IMMU) 3.18 $IMMU
Esophageal Cancer Therapeutic Pipeline Review, H1 2014
M2 - Tue Jul 15, 11:34AM CDT
Research and Markets (http://www.researchandmarkets.com/research/j6z3g6/esophageal_cancer) has announced the addition of the "Esophageal Cancer - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Esophageal Cancer, 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 Esophageal Cancer and special features on late-stage and discontinued projects. 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 Esophageal Cancer - 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 Esophageal Cancer and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Esophageal Cancer products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment of monotherapy and combination therapy pipeline projects - Coverage of the Esophageal Cancer pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products Companies Mentioned - Bristol-Myers Squibb Company - Boehringer Ingelheim GmbH - Amgen Inc. - GlaxoSmithKline plc - Gilead Sciences, Inc. - Daiichi Sankyo Company, Limited - Novartis AG - Ono Pharmaceutical Co., Ltd. - CTI BioPharma Corp. - Genmab A/S - Advaxis, Inc. - Immunomedics, Inc. - Takara Bio Inc. - Synta Pharmaceuticals Corp. - Transgene Biotek Limited - Supratek Pharma Inc. - Glycotope GmbH - Hutchison MediPharma Limited - Advantagene, Inc. - CerRx, Inc. - Cerulean Pharma, Inc. - MacroGenics, Inc. - Merrimack Pharmaceuticals, Inc. - Omnitura Therapeutics Inc. - Omeros Corporation - Oncolys BioPharma Inc. - ImmunoFrontier, Inc. - Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. - Mebiopharm Co., Ltd. - Kite Pharma, Inc For more information visit http://www.researchandmarkets.com/research/j6...eal_cancer
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.
B-Cell Non-Hodgkin Lymphoma - Pipeline Review, H1 2014
M2 - Thu Jun 12, 2:39AM CDT
Research and Markets (http://www.researchandmarkets.com/research/fvkt8j/bcell) has announced the addition of the "B-Cell Non-Hodgkin Lymphoma - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for B-Cell Non-Hodgkin Lymphoma, 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 B-Cell Non-Hodgkin Lymphoma 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 B-Cell Non-Hodgkin Lymphoma - 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 B-Cell Non-Hodgkin Lymphoma and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects Companies Mentioned: - Bristol-Myers Squibb Company - Johnson & Johnson - Boehringer Ingelheim - Amgen - Sanofi - Seattle Genetics - Genentech - MedImmune - Merck & Co - Millennium Pharmaceuticals - Biocon Limited - Ono Pharmaceutical - Sandoz - Celgene Corporation - Incyte Corporation - Merck KGaA - Immunomedics - Portola Pharmaceuticals - Pharmacyclics - Senesco Technologies - Simcere Pharmaceutical - Spectrum Pharmaceuticals - Abiogen Pharma. - Provenance Biopharmaceuticals - LFB Biotechnologies - Areta International - Molecular Templates - Aprogen - BioMedics Japan - Pharmapraxis For more information visit http://www.researchandmarkets.com/research/fvkt8j/bcell
Immunomedics' IMMU-132 Gets Orphan Drug Status - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Tue Jun 10, 5:10PM CDT
Immunomedics, Inc. (IMMU) announced that the FDA has granted orphan drug status to its oncology candidate, IMMU-132.
Diffuse Large B-Cell Lymphoma - Pipeline Review, H1 2014
M2 - Tue Jun 10, 4:08AM CDT
Research and Markets (http://www.researchandmarkets.com/research/ch2twj/diffuse_large) has announced the addition of the "Diffuse Large B-Cell Lymphoma - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Diffuse Large B-Cell Lymphoma, 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 Diffuse Large B-Cell Lymphoma and special features on late-stage and discontinued projects. The report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. 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. Companies Mentioned: - Bristol-Myers Squibb Company - F. Hoffmann-La Roche Ltd. - Amgen Inc. - Sanofi - AstraZeneca PLC - GlaxoSmithKline plc - Seattle Genetics, Inc. - Genentech, Inc. - MedImmune, LLC - Gilead Sciences, Inc. - Merck & Co., Inc. - Infinity Pharmaceuticals, Inc. - Celltrion, Inc. - Millennium Pharmaceuticals, Inc. - Novartis AG - Astellas Pharma Inc. - ImmunoGen, Inc. - Genmab A/S - Celgene Corporation - Incyte Corporation - Immunomedics, Inc. - Idera Pharmaceuticals, Inc. - Portola Pharmaceuticals, Inc. - Pharmacyclics, Inc. For more information visit http://www.researchandmarkets.com/research/ch...fuse_large
Graft Versus Host Disease (GVHD) - Pipeline Review, H1 2014
M2 - Tue Jun 10, 3:51AM CDT
Research and Markets (http://www.researchandmarkets.com/research/wd6llq/graft_versus_host) has announced the addition of the "Graft Versus Host Disease (GVHD) - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Graft Versus Host Disease (GVHD), 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 Graft Versus Host Disease (GVHD) and special features on late-stage and discontinued projects. The report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. 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. Companies Mentioned: - F. Hoffmann-La Roche Ltd. - Osiris Therapeutics, Inc. - Athersys, Inc. - Seattle Genetics, Inc. - Millennium Pharmaceuticals, Inc. - Novartis AG - Rigel Pharmaceuticals, Inc. - Gentium S.p.A. - Immunomedics, Inc. - Mesoblast Limited - Swedish Orphan Biovitrum AB - Accentia Biopharmaceuticals, Inc. - Jazz Pharmaceuticals plc - Soligenix, Inc. - NeoStem, Inc. - Pluristem Therapeutics Inc. - MediPost Co., Ltd. - Alder Biopharmaceuticals Inc. - MSM Protein Technologies, Inc. - Tobira Therapeutics, Inc. - REGiMMUNE Corporation - Adienne Pharma & Biotech - Nephrx Corporation - Dr. Falk Pharma GmbH - Lycera Corp. - Neopharm Ltd. - Pharmicell Co., Ltd. - Sigmoid Pharma Ltd. - Targazyme, Inc. - Kadmon Pharmaceuticals, LLC For more information visit http://www.researchandmarkets.com/research/wd...ersus_host
Hot Stock: Immunomedics, Shares Gain 7.8% (IMMU)
Comtex SmarTrend(R) - Mon Jun 09, 12:46PM CDT
Immunomedics (NASDAQ:IMMU) is one of today's best performing low-priced stocks, up 7.8% to $3.75 on 1.0x average daily volume. Thus far today, Immunomedics has traded 1.0 million shares, vs. average volume of 1.0 million shares per day. The stock has outperformed the Dow (7.8% to the Dow's 0.1%) and outperformed the S&P 500 (7.8% to the S&P's 0.1%) during today's trading.
Immunomedics Announces Orphan Drug Designation for IMMU-132 for Pancreatic Cancer Therapy
GlobeNewswire - Mon Jun 09, 9:18AM CDT
Immunomedics, Inc., (Nasdaq:IMMU) today announced that IMMU-132, the Company's antibody-drug conjugate (ADC) for solid cancer therapy, has received orphan drug status from the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
Scientific Data on Epratuzumab in Systemic Lupus Erythematosus to be Presented at EULAR 2014
GlobeNewswire - Mon Jun 09, 6:00AM CDT
Immunomedics, Inc., (Nasdaq:IMMU) today announced that scientific data on epratuzumab, an investigational therapy for the treatment of systemic lupus erythematosus (SLE), also known as lupus, will be presented at the European League Against Rheumatism (EULAR) 2014 Annual Congress to be held in Paris, France, from June 11 - 14, 2014.
3 Under-$10 Stocks to Trade for Breakouts
at The Street - Fri Jun 06, 8:04AM CDT
These stocks under $10 are within range of triggering breakout trades.
Technical Analysis on Biotech Equities -- Research on Incyte, Progenics Pharma, Immunomedics, and Arqule
PR Newswire - Thu Jun 05, 6:30AM CDT
The trading session on Wednesday, June 04, 2014 ended on a higher note as the Dow Jones Industrial Average finished at 16,737.53, up 0.09% and the NASDAQ Composite closed at 4,251.64, up 0.41%. The S&P 500 finished the day 0.19% higher at 1,927.88. During the trading session, seven out of ten sectors finished on a positive note. The S&P 500 Health Care Sector Index finished the day 0.23% higher at 694.30, and the index has gained 3.81% in the previous one month. Investor-Edge has initiated coverage on the following equities: Incyte Corp. Ltd (NASDAQ: INCY), Progenics Pharmaceuticals Inc. (NASDAQ: PGNX), Immunomedics Inc. (NASDAQ: IMMU) and Arqule Inc. (NASDAQ: ARQL). Free technical research on INCY, PGNX, IMMU and ARQL can be downloaded upon signing up at:
Immunomedics Announces Objective Responses in Five Types of Solid Cancer With IMMU-132
GlobeNewswire - Mon Jun 02, 1:15PM CDT
-- Cancer Types Include Colorectal, Esophageal, Triple-Negative Breast, Small-Cell and Non-Small-Cell Lung -
Immunomedics Reports IMMU-130 is Active in Patients With Irinotecan-Refractory Colorectal Cancer
GlobeNewswire - Mon Jun 02, 8:35AM CDT
Immunomedics, Inc., (Nasdaq:IMMU) today reported 10 of 14 patients (71%) with metastatic colorectal cancer (mCRC) responded to IMMU-130, the Company's novel investigational antibody-drug conjugate (ADC) that comprises an anti-CEACAM5 antibody and SN-38, the active metabolite of irinotecan.
Immunomedics Reports Development of Improved Cancer Immunotherapy at the 2014 Annual Meeting of the American Society of Clinical Oncology
GlobeNewswire - Sun Jun 01, 8:01AM CDT
-- T-cell Redirecting Immunotherapy Enhanced With Interferon-α in Human Pancreatic and Gastric Cancer Models --
Immunomedics Reports Final Efficacy Results of Phase Ib Trial With Yttrium-90-Labeled Clivatuzumab Tetraxetan in Patients With Metastatic Pancreatic Cancer
GlobeNewswire - Sun Jun 01, 8:00AM CDT
Immunomedics, Inc., (Nasdaq:IMMU) today reported an overall disease response rate of 41%, including 2 patients (7%) with partial response and 10 patients (34%) with stable disease as best response, in 29 patients with relapsed/refractory, metastatic pancreatic cancer treated with the investigational pancreatic cancer therapeutic, clivatuzumab tetraxetan labeled with yttrium-90 (Y), in combination with low-dose gemcitabine as a radiosensitizer. This was compared to a control group of 29 similar patients who received Y-clivatuzumab tetraxetan without low-dose gemcitabine. Treatment responses were assessed by computed tomography (CT) based on RECIST criteria.
Immunomedics to Present at Upcoming Healthcare Conferences
GlobeNewswire - Thu May 29, 7:30AM CDT
Immunomedics, Inc., (Nasdaq:IMMU) today announced that the Company will present at two upcoming healthcare conferences:
Lung Adenocarcinoma - Pipeline Review, H1 2014: 14 Company Profiles
M2 - Thu May 29, 6:18AM CDT
Research and Markets (http://www.researchandmarkets.com/research/9s74ck/lung) has announced the addition of the "Lung Adenocarcinoma - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Lung Adenocarcinoma, 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 Lung Adenocarcinoma and special features on late-stage and discontinued projects. This report features investigatory drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by our team. 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. Scope - The report provides a snapshot of the global therapeutic landscape of Lung Adenocarcinoma - 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 Lung Adenocarcinoma and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Lung Adenocarcinoma products under development by companies and universities/research institutes based on information derived from company and industry-specific sources Companies Mentioned: - Amgen - Axelar - BioNumerik Pharmaceuticals - Boehringer Ingelheim - Genmab - Hanmi Pharmaceuticals - Immunomedics - Medisyn Technologies - Merck & Co - Pfizer - Quantum Pharmaceuticals - Takeda Pharmaceutical Company Limited - VG Life Sciences - Vichem Chemie Research For more information visit http://www.researchandmarkets.com/research/9s74ck/lung
Follicular Lymphoma - Pipeline Review, H1 2014
M2 - Thu May 29, 4:15AM CDT
Research and Markets (http://www.researchandmarkets.com/research/97lh2b/follicular) has announced the addition of the "Follicular Lymphoma - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Follicular Lymphoma, 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 Follicular Lymphoma and special features on late-stage and discontinued projects. This report features investigatory drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by our team. 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. Scope - The report provides a snapshot of the global therapeutic landscape of Follicular Lymphoma - 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 Follicular Lymphoma and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects Companies Mentioned: - AbbVie - Accentia Biopharmaceuticals - AmpliMed Corporation - Bayer AG - Boehringer Ingelheim - Bristol-Myers Squibb Company - Celgene Corporation - CureTech - F. Hoffmann-La Roche - Genmab - Gilead Sciences - ImmunoGen - Immunomedics - Infinity Pharmaceuticals - MENTRIK Biotech - Memgen - Merck & Co - Millennium Pharmaceuticals - Novartis - Pharmacyclics - Portola Pharmaceuticals - ProNAi Therapeutics - Sandoz - Xiamen Amoytop Biotech For more information visit http://www.researchandmarkets.com/research/97lh2b/follicular
Immunomedics to Provide Clinical Trial Updates on Solid-Tumor Antibody-Drug Conjugates at Cancer Conference
GlobeNewswire - Mon Mar 31, 7:30AM CDT
Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that four posters will be presented at the 2014 Annual Meeting of the American Association for Cancer Research to be held in San Diego, CA, from April 5 - 9, 2014.
Cohen Milstein Sellers & Toll PLLC Announces the Investigation of Immunomedics, Inc.
Business Wire - Fri Mar 28, 8:52AM CDT
Cohen Milstein Sellers & Toll PLLC is conducting an investigation to determine whether Immunomedics, Inc. ("IMMU" or the "Company"
and certain of its officers and directors made false and misleading statements and/or omissions in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
Esophageal Cancer Therapeutic Pipeline Review, H1 2014
M2 - Tue Jul 15, 11:34AM CDT
Research and Markets (http://www.researchandmarkets.com/research/j6z3g6/esophageal_cancer) has announced the addition of the "Esophageal Cancer - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Esophageal Cancer, 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 Esophageal Cancer and special features on late-stage and discontinued projects. 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 Esophageal Cancer - 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 Esophageal Cancer and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Esophageal Cancer products under development by companies and universities/research institutes based on information derived from company and industry-specific sources - Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages - A detailed assessment of monotherapy and combination therapy pipeline projects - Coverage of the Esophageal Cancer pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products Companies Mentioned - Bristol-Myers Squibb Company - Boehringer Ingelheim GmbH - Amgen Inc. - GlaxoSmithKline plc - Gilead Sciences, Inc. - Daiichi Sankyo Company, Limited - Novartis AG - Ono Pharmaceutical Co., Ltd. - CTI BioPharma Corp. - Genmab A/S - Advaxis, Inc. - Immunomedics, Inc. - Takara Bio Inc. - Synta Pharmaceuticals Corp. - Transgene Biotek Limited - Supratek Pharma Inc. - Glycotope GmbH - Hutchison MediPharma Limited - Advantagene, Inc. - CerRx, Inc. - Cerulean Pharma, Inc. - MacroGenics, Inc. - Merrimack Pharmaceuticals, Inc. - Omnitura Therapeutics Inc. - Omeros Corporation - Oncolys BioPharma Inc. - ImmunoFrontier, Inc. - Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. - Mebiopharm Co., Ltd. - Kite Pharma, Inc For more information visit http://www.researchandmarkets.com/research/j6...eal_cancer
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.
B-Cell Non-Hodgkin Lymphoma - Pipeline Review, H1 2014
M2 - Thu Jun 12, 2:39AM CDT
Research and Markets (http://www.researchandmarkets.com/research/fvkt8j/bcell) has announced the addition of the "B-Cell Non-Hodgkin Lymphoma - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for B-Cell Non-Hodgkin Lymphoma, 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 B-Cell Non-Hodgkin Lymphoma 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 B-Cell Non-Hodgkin Lymphoma - 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 B-Cell Non-Hodgkin Lymphoma and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects Companies Mentioned: - Bristol-Myers Squibb Company - Johnson & Johnson - Boehringer Ingelheim - Amgen - Sanofi - Seattle Genetics - Genentech - MedImmune - Merck & Co - Millennium Pharmaceuticals - Biocon Limited - Ono Pharmaceutical - Sandoz - Celgene Corporation - Incyte Corporation - Merck KGaA - Immunomedics - Portola Pharmaceuticals - Pharmacyclics - Senesco Technologies - Simcere Pharmaceutical - Spectrum Pharmaceuticals - Abiogen Pharma. - Provenance Biopharmaceuticals - LFB Biotechnologies - Areta International - Molecular Templates - Aprogen - BioMedics Japan - Pharmapraxis For more information visit http://www.researchandmarkets.com/research/fvkt8j/bcell
Immunomedics' IMMU-132 Gets Orphan Drug Status - Analyst Blog
Zacks Equity Research - Zacks Investment Research - Tue Jun 10, 5:10PM CDT
Immunomedics, Inc. (IMMU) announced that the FDA has granted orphan drug status to its oncology candidate, IMMU-132.
Diffuse Large B-Cell Lymphoma - Pipeline Review, H1 2014
M2 - Tue Jun 10, 4:08AM CDT
Research and Markets (http://www.researchandmarkets.com/research/ch2twj/diffuse_large) has announced the addition of the "Diffuse Large B-Cell Lymphoma - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Diffuse Large B-Cell Lymphoma, 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 Diffuse Large B-Cell Lymphoma and special features on late-stage and discontinued projects. The report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. 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. Companies Mentioned: - Bristol-Myers Squibb Company - F. Hoffmann-La Roche Ltd. - Amgen Inc. - Sanofi - AstraZeneca PLC - GlaxoSmithKline plc - Seattle Genetics, Inc. - Genentech, Inc. - MedImmune, LLC - Gilead Sciences, Inc. - Merck & Co., Inc. - Infinity Pharmaceuticals, Inc. - Celltrion, Inc. - Millennium Pharmaceuticals, Inc. - Novartis AG - Astellas Pharma Inc. - ImmunoGen, Inc. - Genmab A/S - Celgene Corporation - Incyte Corporation - Immunomedics, Inc. - Idera Pharmaceuticals, Inc. - Portola Pharmaceuticals, Inc. - Pharmacyclics, Inc. For more information visit http://www.researchandmarkets.com/research/ch...fuse_large
Graft Versus Host Disease (GVHD) - Pipeline Review, H1 2014
M2 - Tue Jun 10, 3:51AM CDT
Research and Markets (http://www.researchandmarkets.com/research/wd6llq/graft_versus_host) has announced the addition of the "Graft Versus Host Disease (GVHD) - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Graft Versus Host Disease (GVHD), 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 Graft Versus Host Disease (GVHD) and special features on late-stage and discontinued projects. The report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. 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. Companies Mentioned: - F. Hoffmann-La Roche Ltd. - Osiris Therapeutics, Inc. - Athersys, Inc. - Seattle Genetics, Inc. - Millennium Pharmaceuticals, Inc. - Novartis AG - Rigel Pharmaceuticals, Inc. - Gentium S.p.A. - Immunomedics, Inc. - Mesoblast Limited - Swedish Orphan Biovitrum AB - Accentia Biopharmaceuticals, Inc. - Jazz Pharmaceuticals plc - Soligenix, Inc. - NeoStem, Inc. - Pluristem Therapeutics Inc. - MediPost Co., Ltd. - Alder Biopharmaceuticals Inc. - MSM Protein Technologies, Inc. - Tobira Therapeutics, Inc. - REGiMMUNE Corporation - Adienne Pharma & Biotech - Nephrx Corporation - Dr. Falk Pharma GmbH - Lycera Corp. - Neopharm Ltd. - Pharmicell Co., Ltd. - Sigmoid Pharma Ltd. - Targazyme, Inc. - Kadmon Pharmaceuticals, LLC For more information visit http://www.researchandmarkets.com/research/wd...ersus_host
Hot Stock: Immunomedics, Shares Gain 7.8% (IMMU)
Comtex SmarTrend(R) - Mon Jun 09, 12:46PM CDT
Immunomedics (NASDAQ:IMMU) is one of today's best performing low-priced stocks, up 7.8% to $3.75 on 1.0x average daily volume. Thus far today, Immunomedics has traded 1.0 million shares, vs. average volume of 1.0 million shares per day. The stock has outperformed the Dow (7.8% to the Dow's 0.1%) and outperformed the S&P 500 (7.8% to the S&P's 0.1%) during today's trading.
Immunomedics Announces Orphan Drug Designation for IMMU-132 for Pancreatic Cancer Therapy
GlobeNewswire - Mon Jun 09, 9:18AM CDT
Immunomedics, Inc., (Nasdaq:IMMU) today announced that IMMU-132, the Company's antibody-drug conjugate (ADC) for solid cancer therapy, has received orphan drug status from the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.
Scientific Data on Epratuzumab in Systemic Lupus Erythematosus to be Presented at EULAR 2014
GlobeNewswire - Mon Jun 09, 6:00AM CDT
Immunomedics, Inc., (Nasdaq:IMMU) today announced that scientific data on epratuzumab, an investigational therapy for the treatment of systemic lupus erythematosus (SLE), also known as lupus, will be presented at the European League Against Rheumatism (EULAR) 2014 Annual Congress to be held in Paris, France, from June 11 - 14, 2014.
3 Under-$10 Stocks to Trade for Breakouts
at The Street - Fri Jun 06, 8:04AM CDT
These stocks under $10 are within range of triggering breakout trades.
Technical Analysis on Biotech Equities -- Research on Incyte, Progenics Pharma, Immunomedics, and Arqule
PR Newswire - Thu Jun 05, 6:30AM CDT
The trading session on Wednesday, June 04, 2014 ended on a higher note as the Dow Jones Industrial Average finished at 16,737.53, up 0.09% and the NASDAQ Composite closed at 4,251.64, up 0.41%. The S&P 500 finished the day 0.19% higher at 1,927.88. During the trading session, seven out of ten sectors finished on a positive note. The S&P 500 Health Care Sector Index finished the day 0.23% higher at 694.30, and the index has gained 3.81% in the previous one month. Investor-Edge has initiated coverage on the following equities: Incyte Corp. Ltd (NASDAQ: INCY), Progenics Pharmaceuticals Inc. (NASDAQ: PGNX), Immunomedics Inc. (NASDAQ: IMMU) and Arqule Inc. (NASDAQ: ARQL). Free technical research on INCY, PGNX, IMMU and ARQL can be downloaded upon signing up at:
Immunomedics Announces Objective Responses in Five Types of Solid Cancer With IMMU-132
GlobeNewswire - Mon Jun 02, 1:15PM CDT
-- Cancer Types Include Colorectal, Esophageal, Triple-Negative Breast, Small-Cell and Non-Small-Cell Lung -
Immunomedics Reports IMMU-130 is Active in Patients With Irinotecan-Refractory Colorectal Cancer
GlobeNewswire - Mon Jun 02, 8:35AM CDT
Immunomedics, Inc., (Nasdaq:IMMU) today reported 10 of 14 patients (71%) with metastatic colorectal cancer (mCRC) responded to IMMU-130, the Company's novel investigational antibody-drug conjugate (ADC) that comprises an anti-CEACAM5 antibody and SN-38, the active metabolite of irinotecan.
Immunomedics Reports Development of Improved Cancer Immunotherapy at the 2014 Annual Meeting of the American Society of Clinical Oncology
GlobeNewswire - Sun Jun 01, 8:01AM CDT
-- T-cell Redirecting Immunotherapy Enhanced With Interferon-α in Human Pancreatic and Gastric Cancer Models --
Immunomedics Reports Final Efficacy Results of Phase Ib Trial With Yttrium-90-Labeled Clivatuzumab Tetraxetan in Patients With Metastatic Pancreatic Cancer
GlobeNewswire - Sun Jun 01, 8:00AM CDT
Immunomedics, Inc., (Nasdaq:IMMU) today reported an overall disease response rate of 41%, including 2 patients (7%) with partial response and 10 patients (34%) with stable disease as best response, in 29 patients with relapsed/refractory, metastatic pancreatic cancer treated with the investigational pancreatic cancer therapeutic, clivatuzumab tetraxetan labeled with yttrium-90 (Y), in combination with low-dose gemcitabine as a radiosensitizer. This was compared to a control group of 29 similar patients who received Y-clivatuzumab tetraxetan without low-dose gemcitabine. Treatment responses were assessed by computed tomography (CT) based on RECIST criteria.
Immunomedics to Present at Upcoming Healthcare Conferences
GlobeNewswire - Thu May 29, 7:30AM CDT
Immunomedics, Inc., (Nasdaq:IMMU) today announced that the Company will present at two upcoming healthcare conferences:
Lung Adenocarcinoma - Pipeline Review, H1 2014: 14 Company Profiles
M2 - Thu May 29, 6:18AM CDT
Research and Markets (http://www.researchandmarkets.com/research/9s74ck/lung) has announced the addition of the "Lung Adenocarcinoma - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Lung Adenocarcinoma, 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 Lung Adenocarcinoma and special features on late-stage and discontinued projects. This report features investigatory drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by our team. 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. Scope - The report provides a snapshot of the global therapeutic landscape of Lung Adenocarcinoma - 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 Lung Adenocarcinoma and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Lung Adenocarcinoma products under development by companies and universities/research institutes based on information derived from company and industry-specific sources Companies Mentioned: - Amgen - Axelar - BioNumerik Pharmaceuticals - Boehringer Ingelheim - Genmab - Hanmi Pharmaceuticals - Immunomedics - Medisyn Technologies - Merck & Co - Pfizer - Quantum Pharmaceuticals - Takeda Pharmaceutical Company Limited - VG Life Sciences - Vichem Chemie Research For more information visit http://www.researchandmarkets.com/research/9s74ck/lung
Follicular Lymphoma - Pipeline Review, H1 2014
M2 - Thu May 29, 4:15AM CDT
Research and Markets (http://www.researchandmarkets.com/research/97lh2b/follicular) has announced the addition of the "Follicular Lymphoma - Pipeline Review, H1 2014" report to their offering. This report provides comprehensive information on the therapeutic development for Follicular Lymphoma, 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 Follicular Lymphoma and special features on late-stage and discontinued projects. This report features investigatory drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by our team. 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. Scope - The report provides a snapshot of the global therapeutic landscape of Follicular Lymphoma - 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 Follicular Lymphoma and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects Companies Mentioned: - AbbVie - Accentia Biopharmaceuticals - AmpliMed Corporation - Bayer AG - Boehringer Ingelheim - Bristol-Myers Squibb Company - Celgene Corporation - CureTech - F. Hoffmann-La Roche - Genmab - Gilead Sciences - ImmunoGen - Immunomedics - Infinity Pharmaceuticals - MENTRIK Biotech - Memgen - Merck & Co - Millennium Pharmaceuticals - Novartis - Pharmacyclics - Portola Pharmaceuticals - ProNAi Therapeutics - Sandoz - Xiamen Amoytop Biotech For more information visit http://www.researchandmarkets.com/research/97lh2b/follicular
Immunomedics to Provide Clinical Trial Updates on Solid-Tumor Antibody-Drug Conjugates at Cancer Conference
GlobeNewswire - Mon Mar 31, 7:30AM CDT
Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that four posters will be presented at the 2014 Annual Meeting of the American Association for Cancer Research to be held in San Diego, CA, from April 5 - 9, 2014.
Cohen Milstein Sellers & Toll PLLC Announces the Investigation of Immunomedics, Inc.
Business Wire - Fri Mar 28, 8:52AM CDT
Cohen Milstein Sellers & Toll PLLC is conducting an investigation to determine whether Immunomedics, Inc. ("IMMU" or the "Company"
and certain of its officers and directors made false and misleading statements and/or omissions in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. 
