Biliary Cirrhosis - Pipeline Review, H1 2015 Summary Global Markets Direct's, 'Biliary Cirrhosis - Pipeline Review, H1 2015', provides an overview of the Biliary Cirrhosis's therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Biliary Cirrhosis, 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 Biliary Cirrhosis 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 Biliary Cirrhosis - 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 Biliary Cirrhosis and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Biliary Cirrhosis 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 Biliary Cirrhosis pipeline on the basis of target, MoA, route of administration and molecule type - Latest news and deals relating related to pipeline products Reasons 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 Biliary Cirrhosis - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - Devise corrective measures for pipeline projects by understanding Biliary Cirrhosis 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 4 List of Figures 5 Introduction 6 Global Markets Direct Report Coverage 6 Biliary Cirrhosis Overview 7 Therapeutics Development 8 Pipeline Products for Biliary Cirrhosis - Overview 8 Pipeline Products for Biliary Cirrhosis - Comparative Analysis 9 Biliary Cirrhosis - Therapeutics under Development by Companies 10 Biliary Cirrhosis - Pipeline Products Glance 12 Late Stage Products 12 Clinical Stage Products 13 Early Stage Products 14 Biliary Cirrhosis - Products under Development by Companies 15 Biliary Cirrhosis - Companies Involved in Therapeutics Development 16 AlbireoPharma 16 Dr. Falk Pharma GmbH 17 GlaxoSmithKline plc 18 Intercept Pharmaceuticals, Inc. 19 Johnson & Johnson 20 MediGene AG 21 NGM Biopharmaceuticals, Inc. 22 Shire Plc 23 Virobay Inc. 24 Biliary Cirrhosis - Therapeutics Assessment 25 Assessment by Monotherapy Products 25 Assessment by Target 26 Assessment by Mechanism of Action 28 Assessment by Route of Administration 30 Assessment by Molecule Type 32 Drug Profiles 34 A-4250 - Drug Profile 34 Product Description 34 Mechanism of Action 34 R&D Progress 34 budesonide - Drug Profile 35 Product Description 35 Mechanism of Action 35 R&D Progress 35 FFP-104 - Drug Profile 38 Product Description 38 Mechanism of Action 38 R&D Progress 38 GSK-2330672 - Drug Profile 39 Product Description 39 Mechanism of Action 39 R&D Progress 39 Leukothera - Drug Profile 40 Product Description 40 Mechanism of Action 40 R&D Progress 40 NGM-282 - Drug Profile 41 Product Description 41 Mechanism of Action 41 R&D Progress 41 obeticholic acid - Drug Profile 42 Product Description 42 Mechanism of Action 42 R&D Progress 42 RhuDex - Drug Profile 45 Product Description 45 Mechanism of Action 45 R&D Progress 45 SHP-625 - Drug Profile 47 Product Description 47 Mechanism of Action 47 R&D Progress 47 ustekinumab - Drug Profile 48 Product Description 48 Mechanism of Action 48 R&D Progress 48 VBY-825 - Drug Profile 50 Product Description 50 Mechanism of Action 50 R&D Progress 50 Biliary Cirrhosis - Recent Pipeline Updates 51 Biliary Cirrhosis - Dormant Projects 62 Biliary Cirrhosis - Product Development Milestones 63 Featured News & Press Releases 63 Nov 08, 2014: Intercept Announces Additional Data for OCA in Primary Biliary Cirrhosis 63 May 28, 2014: Intercept Announces that FDA Grants Fast Track Designation to Obeticholic Acid for the Treatment of Patients with Primary Biliary Cirrhosis 64 Apr 12, 2014: Intercept Reports Additional Positive Data From POISE Trial at EASL Late-Breaker Session 64 Apr 11, 2014: Intercept Announces Preclinical Data Demonstrating OCA's Potential Role in Preventing Complications of Cirrhosis 66 Apr 04, 2014: Data From Intercept's Pivotal Phase 3 POISE Trial of Its FXR Agonist Obeticholic Acid to Treat Primary Biliary Cirrhosis and Other Key Obeticholic Acid Data to be Presented at EASL 2014 67 Mar 16, 2014: Intercept Announces Positive Pivotal Phase 3 POISE Trial Results 68 Jan 09, 2014: Intercept Provides 2013 Year-End Update and 2014 Anticipated Milestones 69 Dec 13, 2013: Medigene Granted Additional Patent for RhuDex for the Treatment of Autoimmune Diseases 71 Nov 18, 2013: Lumena Pharmaceuticals Receives Positive Opinion for Orphan Drug Designation in the European Union for LUM001 in Four Rare Liver Diseases 72 Oct 29, 2013: Lumena Pharmaceuticals Initiates the CLARITY Phase II Study of LUM001 in Patients with Primary Biliary Cirrhosis 73 Appendix 74 Methodology 74 Coverage 74 Secondary Research 74 Primary Research 74 Expert Panel Validation 74 Contact Us 75 Disclaimer 75
List of Tables Number of Products under Development for Biliary Cirrhosis, H1 2015 8 Number of Products under Development for Biliary Cirrhosis - Comparative Analysis, H1 2015 9 Number of Products under Development by Companies, H1 2015 11 Comparative Analysis by Late Stage Development, H1 2015 12 Comparative Analysis by Clinical Stage Development, H1 2015 13 Comparative Analysis by Early Stage Development, H1 2015 14 Products under Development by Companies, H1 2015 15 Biliary Cirrhosis - Pipeline by AlbireoPharma, H1 2015 16 Biliary Cirrhosis - Pipeline by Dr. Falk Pharma GmbH, H1 2015 17 Biliary Cirrhosis - Pipeline by GlaxoSmithKline plc, H1 2015 18 Biliary Cirrhosis - Pipeline by Intercept Pharmaceuticals, Inc., H1 2015 19 Biliary Cirrhosis - Pipeline by Johnson & Johnson, H1 2015 20 Biliary Cirrhosis - Pipeline by MediGene AG, H1 2015 21 Biliary Cirrhosis - Pipeline by NGM Biopharmaceuticals, Inc., H1 2015 22 Biliary Cirrhosis - Pipeline by Shire Plc, H1 2015 23 Biliary Cirrhosis - Pipeline by Virobay Inc., H1 2015 24 Assessment by Monotherapy Products, H1 2015 25 Number of Products by Stage and Target, H1 2015 27 Number of Products by Stage and Mechanism of Action, H1 2015 29 Number of Products by Stage and Route of Administration, H1 2015 31 Number of Products by Stage and Molecule Type, H1 2015 33 Biliary Cirrhosis Therapeutics - Recent Pipeline Updates, H1 2015 51 Biliary Cirrhosis - Dormant Projects, H1 2015 62
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