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Published: Apr, 2015 | Pages:
199 | Publisher: Global Markets Direct
Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)
Waldenstrom Macroglobulinemia - Pipeline Review, H1 2015 Summary Global Markets Direct's, 'Waldenstrom Macroglobulinemia - Pipeline Review, H1 2015', provides an overview of the Waldenstrom Macroglobulinemia's therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Waldenstrom Macroglobulinemia, 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 Waldenstrom Macroglobulinemia and special features on late-stage and discontinued projects. Global Markets Direct's 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 Global Markets Direct's 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 Global Markets Direct's 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. 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. Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease. Scope - The report provides a snapshot of the global therapeutic landscape of Waldenstrom Macroglobulinemia - 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 Waldenstrom Macroglobulinemia and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Waldenstrom Macroglobulinemia 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 Waldenstrom Macroglobulinemia pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products Reason To Buy - Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies - Identify emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage - Develop strategic initiatives by understanding the focus areas of leading companies - Identify and understand important and diverse types of therapeutics under development for Waldenstrom Macroglobulinemia - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - Devise corrective measures for pipeline projects by understanding Waldenstrom Macroglobulinemia pipeline depth and focus of Indication therapeutics - Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope - Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline
Table of Contents
Table of Contents 2 List of Tables 6 List of Figures 7 Introduction 8 Global Markets Direct Report Coverage 8 Waldenstrom Macroglobulinemia Overview 9 Therapeutics Development 10 Pipeline Products for Waldenstrom Macroglobulinemia - Overview 10 Pipeline Products for Waldenstrom Macroglobulinemia - Comparative Analysis 11 Waldenstrom Macroglobulinemia - Therapeutics under Development by Companies 12 Waldenstrom Macroglobulinemia - Pipeline Products Glance 14 Late Stage Products 14 Clinical Stage Products 15 Early Stage Products 16 Waldenstrom Macroglobulinemia - Products under Development by Companies 17 Waldenstrom Macroglobulinemia - Companies Involved in Therapeutics Development 19 AbbVie Inc. 19 arGEN-X BV 20 Bayer AG 21 Calithera Biosciences, Inc. 22 Celgene Corporation 23 Genmab A/S 24 Gilead Sciences, Inc. 25 Idera Pharmaceuticals, Inc. 26 Immune System Therapeutics Ltd. 27 Incyte Corporation 28 Karyopharm Therapeutics, Inc. 29 Merck KGaA 30 Millennium Pharmaceuticals, Inc. 31 Nimbus Therapeutics, LLC 32 Nordic Nanovector AS 33 Novartis AG 34 Onyx Pharmaceuticals, Inc. 35 Pharmacyclics, Inc. 36 Waldenstrom Macroglobulinemia - Therapeutics Assessment 37 Assessment by Monotherapy Products 37 Assessment by Target 38 Assessment by Mechanism of Action 40 Assessment by Route of Administration 42 Assessment by Molecule Type 44 Drug Profiles 46 ACP-196 - Drug Profile 46 Product Description 46 Mechanism of Action 46 R&D Progress 46 ARGX-110 - Drug Profile 48 Product Description 48 Mechanism of Action 48 R&D Progress 48 Betalutin - Drug Profile 51 Product Description 51 Mechanism of Action 51 R&D Progress 51 carfilzomib - Drug Profile 53 Product Description 53 Mechanism of Action 53 R&D Progress 53 CB-839 - Drug Profile 57 Product Description 57 Mechanism of Action 57 R&D Progress 57 copanlisib - Drug Profile 58 Product Description 58 Mechanism of Action 58 R&D Progress 58 DI-B4 - Drug Profile 61 Product Description 61 Mechanism of Action 61 R&D Progress 61 everolimus - Drug Profile 62 Product Description 62 Mechanism of Action 62 R&D Progress 62 FV-162 - Drug Profile 67 Product Description 67 Mechanism of Action 67 R&D Progress 67 FV-214 - Drug Profile 68 Product Description 68 Mechanism of Action 68 R&D Progress 68 GS-9973 - Drug Profile 69 Product Description 69 Mechanism of Action 69 R&D Progress 69 ibrutinib - Drug Profile 70 Product Description 70 Mechanism of Action 70 R&D Progress 70 idelalisib - Drug Profile 76 Product Description 76 Mechanism of Action 76 R&D Progress 76 IMO-8400 - Drug Profile 79 Product Description 79 Mechanism of Action 79 R&D Progress 79 INCB-39110 - Drug Profile 81 Product Description 81 Mechanism of Action 81 R&D Progress 81 INCB-40093 - Drug Profile 83 Product Description 83 Mechanism of Action 83 R&D Progress 83 IST-1097 - Drug Profile 84 Product Description 84 Mechanism of Action 84 R&D Progress 84 ixazomib citrate - Drug Profile 85 Product Description 85 Mechanism of Action 85 R&D Progress 85 lenalidomide - Drug Profile 89 Product Description 89 Mechanism of Action 89 R&D Progress 89 ofatumumab - Drug Profile 93 Product Description 93 Mechanism of Action 93 R&D Progress 93 oprozomib - Drug Profile 98 Product Description 98 Mechanism of Action 98 R&D Progress 98 pevonedistat hydrochloride - Drug Profile 100 Product Description 100 Mechanism of Action 100 R&D Progress 100 sapanisertib - Drug Profile 102 Product Description 102 Mechanism of Action 102 R&D Progress 102 selinexor - Drug Profile 104 Product Description 104 Mechanism of Action 104 R&D Progress 104 Small Molecules to Inhibit IRAK4 for Immunology and Oncology - Drug Profile 109 Product Description 109 Mechanism of Action 109 R&D Progress 109 spebrutinib besylate - Drug Profile 110 Product Description 110 Mechanism of Action 110 R&D Progress 110 venetoclax - Drug Profile 112 Product Description 112 Mechanism of Action 112 R&D Progress 112 Waldenstrom Macroglobulinemia - Recent Pipeline Updates 115 Waldenstrom Macroglobulinemia - Dormant Projects 188 Waldenstrom Macroglobulinemia - Dormant Projects 188 Waldenstrom Macroglobulinemia - Discontinued Products 189 Waldenstrom Macroglobulinemia - Product Development Milestones 190 Featured News & Press Releases 190 Apr 09, 2015: New Longer-Term IMBRUVICA (ibrutinib) Data Show High Response Rates in Patients with Waldenstrom's Macroglobulinemia 190 Jan 29, 2015: U.S. FDA Approves IMBRUVICA (ibrutinib) for the Treatment of Waldenstrom's Macroglobulinemia: First FDA-Approved Therapy for This Disease 191 Dec 22, 2014: Pharmacyclics Announces Update on IMBRUVICA (ibrutinib) Waldenstrom's macroglobulinemia Submission 192 Dec 01, 2014: New IMBRUVICA (ibrutinib) Application Accepted by European Medicines Agency for Waldenstrom's Macroglobulinemia 192 Nov 03, 2014: arGEN-X Submits Investigational New Drug Application to Evaluate ARGX-110 in Waldenstr�m's Macroglobulinemia 193 Oct 20, 2014: IMBRUVICA (ibrutinib) Supplemental New Drug Application Submitted to the U.S. FDA for Waldenstrom's macroglobulinemia 193 Jun 10, 2014: arGEN-X and the Leukemia & Lymphoma Society Partner on the Development of ARGX-110 for the Treatment of Waldenstr�m's Macroglobulinemia 194 Nov 07, 2013: Amgen and Onyx Pharmaceuticals Announce Upcoming Data Presentations On Oprozomib at 55th American Society of Hematology Annual Meeting 195 Jun 20, 2013: Pharmacyclics Presents Ibrutinib Monotherapy Clinical Trial Data In Patients With Waldenstrom's Macroglobulinemia At ICML 195 Apr 01, 2013: Onyx Pharma To Present Data On Oprozomib At 14th International Myeloma Workshop 196 Appendix 198 Methodology 198 Coverage 198 Secondary Research 198 Primary Research 198 Expert Panel Validation 198 Contact Us 198 Disclaimer 199
List of Tables
Number of Products under Development for Waldenstrom Macroglobulinemia, H1 2015 10 Number of Products under Development for Waldenstrom Macroglobulinemia - Comparative Analysis, H1 2015 11 Number of Products under Development by Companies, H1 2015 13 Comparative Analysis by Late Stage Development, H1 2015 14 Comparative Analysis by Clinical Stage Development, H1 2015 15 Comparative Analysis by Early Stage Development, H1 2015 16 Products under Development by Companies, H1 2015 17 Products under Development by Companies, H1 2015 (Contd..1) 18 Waldenstrom Macroglobulinemia - Pipeline by AbbVie Inc., H1 2015 19 Waldenstrom Macroglobulinemia - Pipeline by arGEN-X BV, H1 2015 20 Waldenstrom Macroglobulinemia - Pipeline by Bayer AG, H1 2015 21 Waldenstrom Macroglobulinemia - Pipeline by Calithera Biosciences, Inc., H1 2015 22 Waldenstrom Macroglobulinemia - Pipeline by Celgene Corporation, H1 2015 23 Waldenstrom Macroglobulinemia - Pipeline by Genmab A/S, H1 2015 24 Waldenstrom Macroglobulinemia - Pipeline by Gilead Sciences, Inc., H1 2015 25 Waldenstrom Macroglobulinemia - Pipeline by Idera Pharmaceuticals, Inc., H1 2015 26 Waldenstrom Macroglobulinemia - Pipeline by Immune System Therapeutics Ltd., H1 2015 27 Waldenstrom Macroglobulinemia - Pipeline by Incyte Corporation, H1 2015 28 Waldenstrom Macroglobulinemia - Pipeline by Karyopharm Therapeutics, Inc., H1 2015 29 Waldenstrom Macroglobulinemia - Pipeline by Merck KGaA, H1 2015 30 Waldenstrom Macroglobulinemia - Pipeline by Millennium Pharmaceuticals, Inc., H1 2015 31 Waldenstrom Macroglobulinemia - Pipeline by Nimbus Therapeutics, LLC, H1 2015 32 Waldenstrom Macroglobulinemia - Pipeline by Nordic Nanovector AS, H1 2015 33 Waldenstrom Macroglobulinemia - Pipeline by Novartis AG, H1 2015 34 Waldenstrom Macroglobulinemia - Pipeline by Onyx Pharmaceuticals, Inc., H1 2015 35 Waldenstrom Macroglobulinemia - Pipeline by Pharmacyclics, Inc., H1 2015 36 Assessment by Monotherapy Products, H1 2015 37 Number of Products by Stage and Target, H1 2015 39 Number of Products by Stage and Mechanism of Action, H1 2015 41 Number of Products by Stage and Route of Administration, H1 2015 43 Number of Products by Stage and Molecule Type, H1 2015 45 Waldenstrom Macroglobulinemia Therapeutics - Recent Pipeline Updates, H1 2015 115 Waldenstrom Macroglobulinemia - Dormant Projects, H1 2015 188 Waldenstrom Macroglobulinemia - Discontinued Products, H1 2015 189
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