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Published: Jun, 2015 | Pages:
43 | Publisher: Global Markets Direct
Industry: Pharmaceuticals & Healthcare | Report Format: Electronic (PDF)
Hypoparathyroidism - Pipeline Review, H1 2015 Summary Global Markets Direct's, 'Hypoparathyroidism - Pipeline Review, H1 2015', provides an overview of the Hypoparathyroidism's therapeutic pipeline. This report provides comprehensive information on the therapeutic development for Hypoparathyroidism, 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 Hypoparathyroidism 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 Hypoparathyroidism - 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 Hypoparathyroidism and enlists all their major and minor projects - The report summarizes all the dormant and discontinued pipeline projects - A review of the Hypoparathyroidism 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 Hypoparathyroidism 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 Hypoparathyroidism - Plan mergers and acquisitions effectively by identifying key players of the most promising pipeline - Devise corrective measures for pipeline projects by understanding Hypoparathyroidism 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 4 Introduction 5 Global Markets Direct Report Coverage 5 Hypoparathyroidism Overview 6 Therapeutics Development 7 Pipeline Products for Hypoparathyroidism - Overview 7 Pipeline Products for Hypoparathyroidism - Comparative Analysis 8 Hypoparathyroidism - Therapeutics under Development by Companies 9 Hypoparathyroidism - Pipeline Products Glance 10 Late Stage Products 10 Clinical Stage Products 11 Early Stage Products 12 Hypoparathyroidism - Products under Development by Companies 13 Hypoparathyroidism - Companies Involved in Therapeutics Development 14 Chugai Pharmaceutical Co., Ltd. 14 Rhein-Minapharm Biogenetics SAE 15 Shire Plc 16 Hypoparathyroidism - Therapeutics Assessment 17 Assessment by Monotherapy Products 17 Assessment by Target 18 Assessment by Mechanism of Action 20 Assessment by Route of Administration 22 Assessment by Molecule Type 24 Drug Profiles 26 Eu-232 - Drug Profile 26 Product Description 26 Mechanism of Action 26 R&D Progress 26 parathyroid hormone (recombinant) - Drug Profile 27 Product Description 27 Mechanism of Action 27 R&D Progress 27 PCO-371 - Drug Profile 30 Product Description 30 Mechanism of Action 30 R&D Progress 30 Recombinant Protein to Agonize PTH-R for Hypoparathyroidism - Drug Profile 31 Product Description 31 Mechanism of Action 31 R&D Progress 31 teriparatide - Drug Profile 32 Product Description 32 Mechanism of Action 32 R&D Progress 32 Hypoparathyroidism - Recent Pipeline Updates 33 Hypoparathyroidism - Product Development Milestones 36 Hypoparathyroidism - Product Development Milestones 36 Featured News & Press Releases 36 Jan 23, 2015: FDA approves Natpara to control low blood calcium levels in patients with hypoparathyroidism 36 Dec 02, 2014: European Medicines Agency Validates Marketing Authorization Application for Natpar (parathyroid hormone (rDNA)) in Hypoparathyroidism 37 Oct 23, 2014: PDUFA Action Date For Natpara BLA Extended Three Months To January 24, 2015 37 Sep 12, 2014: FDA Advisory Committee Recommends Approval of Natpara for Long-Term Treatment of Hypoparathyroidism 38 Sep 12, 2014: FDA Advisory Committee to Review Natpara Biologics License Application 38 Sep 10, 2014: FDA Posts Briefing Materials for Advisory Committee Meeting Reviewing Natpara® for Hypoparathyroidism 38 Jul 24, 2014: PARADOX Findings Published in Endocrine Practice Describe High Burden of Illness in Patients with Hypoparathyroidism 39 Jun 10, 2014: NPS Pharma Reports Change in Tentative Date of FDA Advisory Committee Review of Natpara BLA to September 12 - PDUFA Date of October 24 Remains Unchanged 40 Jan 07, 2014: NPS Pharmaceuticals Announces FDA Acceptance of Biologics License Application for Natpara for the Treatment of Hypoparathyroidism 40 Jan 03, 2014: NPS Pharmaceuticals Receives Orphan Drug Designation for Natpara in Europe 41 Appendix 42 Methodology 42 Coverage 42 Secondary Research 42 Primary Research 42 Expert Panel Validation 42 Contact Us 42 Disclaimer 43
List of Tables
Number of Products under Development for Hypoparathyroidism, H1 2015 7 Number of Products under Development for Hypoparathyroidism - Comparative Analysis, H1 2015 8 Number of Products under Development by Companies, H1 2015 9 Comparative Analysis by Late Stage Development, H1 2015 10 Comparative Analysis by Clinical Stage Development, H1 2015 11 Comparative Analysis by Early Stage Development, H1 2015 12 Products under Development by Companies, H1 2015 13 Hypoparathyroidism - Pipeline by Chugai Pharmaceutical Co., Ltd., H1 2015 14 Hypoparathyroidism - Pipeline by Rhein-Minapharm Biogenetics SAE, H1 2015 15 Hypoparathyroidism - Pipeline by Shire Plc, H1 2015 16 Assessment by Monotherapy Products, H1 2015 17 Number of Products by Stage and Target, H1 2015 19 Number of Products by Stage and Mechanism of Action, H1 2015 21 Number of Products by Stage and Route of Administration, H1 2015 23 Number of Products by Stage and Molecule Type, H1 2015 25 Hypoparathyroidism Therapeutics - Recent Pipeline Updates, H1 2015 33
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