Posts Tagged ‘US’

Washington Adopting a Five Pointed Star 28×42 Giclee on Canvas

  • Manufactured to the Highest Quality Available.
  • Design is stylish and innovative. Satisfaction Ensured.
  • Great Gift Idea.

Product Description
Series: US PresidentsArtist: UnknownPeriod: Source country: USASource Year: 28 inch by 42 inch Giclee print on Canvas.All files are stored digitally and are ready for reproduction. The quality is closely monitored to ensure professional results.This item is custom made per order.

Washington Adopting a Five Pointed Star 28×42 Giclee on Canvas

Adoption Information : About Foreign Adoptions


There are more options in foreign adoptions than for adoptions in the US, but adoptions through foreign channels aren’t any easier than domestic adoptions. Discover how issues of citizenship and immigration enter into foreign adoptions withhelp from a certified family mediator in this free video on adoption information. Expert: Robert Todd Bio: Robert Todd is the managing partner and president of Robert M. Todd, PA and Family Law Solutions. Filmmaker: Christopher Rokosz

Orphan Drugs In Europe: Pricing, Reimbursement, Funding And Market Access Issues

In order to raise public awareness, 29 February 2008 was dedicated the first European rare disease day (‘a rare day for very special people’), but European payers need no reminding of the significance of rare disease treatments, generally known as orphan drugs.

Eight years earlier, EU Regulation 141/2000 was enacted to encourage R&D in rare diseases and increase orphan drug output. By any standard the Regulation has been a major success. Almost 800 designation applications have been made, with 44 orphan medicines from 31 sponsoring companies receiving pan-European marketing approval. An estimated 1.6 million patients with 38 different rare diseases have potentially benefited, and the surge of interest in the area has offered hope to many more. Orphan drugs accounted for 23% of all new marketing applications to the EMEA in 2006 alone.

Rare diseases and their treatments may still be emotive territory, with a strong patient voice and genuine unmet need, but the pendulum is swinging from a guarantee of ‘special status’ when it comes to public reimbursement to issues of budgetary impact and cost effectiveness – not only because of the high cost of orphan drugs themselves, but the growing number of target diseases and treatments, associated new costs of medical education and diagnosis, and the need for chronic disease management.

Questions answered by this report include:

What is the actual in-market status of all EU designated orphan drugs with marketing authorisations up to the beginning of 2008?
Which drugs are covered by reimbursement, which are not?
Are special funds available for orphan drugs?
Where is health technology assessment required?
How large is the European price corridor for orphan drugs?
Is there a relationship between target patient population and price?
How do orphan drug policies differ across the leading European countries?
Do payers view all orphan drugs as unique?

Table of Contents :  

Executive Summary

1. Introduction
1.1 What are Orphan Drugs?
1.2 What are the P&R Issues with Orphan Drugs?

2. EU Orphan Drug Regulation
2.1 Objectives
2.2.Qualifying Criteria
2.3 Procedure/Timetable
2.4 Incentives
2.4.1 Information
2.4.2 R&D
2.4.3 Protocol Assistance
2.4.4 Marketing Approval Assistance
2.4.4.1 Priority review/fast track
2.4.4.2 Lower regulatory fees
2.4.5 Market Exclusivity
2.4.5.1 Exclusivity withdrawn?
2.5 Comparison with US Orphan Drug Act
2.6 Results
2.6.1 Designation
2.6.2 Marketing Approval
2.6.3 Medical Benefit

For more information please contact :

http://www.aarkstore.com/reports/Orphan-Drugs-in-Europe-Pricing-Reimbursement-Funding-and-Market-Access-Issues-1048.html

http://blogs.aarkstore.com/

From: Aarkstore Enterprise
Contact: Neel
Email: press@aarkstore.com
URL: www.aarkstore.com

Orphan Drugs in Europe: Pricing, Reimbursement, Funding and Market Access Issues- Aarkstore Enterprise

In order to raise public awareness, 29 February 2008 was dedicated the first European rare disease day (‘a rare day for very special people’), but European payers need no reminding of the significance of rare disease treatments, generally known as orphan drugs.

Eight years earlier, EU Regulation 141/2000 was enacted to encourage R&D in rare diseases and increase orphan drug output. By any standard the Regulation has been a major success. Almost 800 designation applications have been made, with 44 orphan medicines from 31 sponsoring companies receiving pan-European marketing approval. An estimated 1.6 million patients with 38 different rare diseases have potentially benefited, and the surge of interest in the area has offered hope to many more. Orphan drugs accounted for 23% of all new marketing applications to the EMEA in 2006 alone.

Rare diseases and their treatments may still be emotive territory, with a strong patient voice and genuine unmet need, but the pendulum is swinging from a guarantee of ‘special status’ when it comes to public reimbursement to issues of budgetary impact and cost effectiveness – not only because of the high cost of orphan drugs themselves, but the growing number of target diseases and treatments, associated new costs of medical education and diagnosis, and the need for chronic disease management.

Questions answered by this report include:

What is the actual in-market status of all EU designated orphan drugs with marketing authorisations up to the beginning of 2008?
Which drugs are covered by reimbursement, which are not?
Are special funds available for orphan drugs?
Where is health technology assessment required?
How large is the European price corridor for orphan drugs?
Is there a relationship between target patient population and price?
How do orphan drug policies differ across the leading European countries?
Do payers view all orphan drugs as unique?

Table of Contents : 

Executive Summary

1. Introduction
1.1 What are Orphan Drugs?
1.2 What are the P&R Issues with Orphan Drugs?

2. EU Orphan Drug Regulation
2.1 Objectives
2.2.Qualifying Criteria
2.3 Procedure/Timetable
2.4 Incentives
2.4.1 Information
2.4.2 R&D
2.4.3 Protocol Assistance
2.4.4 Marketing Approval Assistance
2.4.4.1 Priority review/fast track
2.4.4.2 Lower regulatory fees
2.4.5 Market Exclusivity
2.4.5.1 Exclusivity withdrawn?
2.5 Comparison with US Orphan Drug Act
2.6 Results
2.6.1 Designation
2.6.2 Marketing Approval
2.6.3 Medical Benefit
3. Compassionate Use

4. Paediatric Regulation

For more information please contact :

http://www.aarkstore.com/reports/Orphan-Drugs-in-Europe-Pricing-Reimbursement-Funding-and-Market-Access-Issues-1048.html

http://blogs.aarkstore.com/

From:Aarkstore Enterprise
Contact: Neel
Email: press@aarkstore.com
http://www.aarkstore.com

Adoptive Family Testimony – Older Child Adoption


This adoptive mother shares her story and experience in working with Bethany Christian Services to adopt an older child in the US foster care system as a single parent. When she learned about the many waiting children, she felt called to adopt an older child.

(CNN) Larry King Live “Orphanages & Adoptions for Haiti”


January 29, 2010 CNN Headquarters in Atlanta, Georgia. Larry King (of CNN), Mardie Caldwell (Lifetime Adoption Expert), Tionne “T-Boz” Watkins (Member of Multi-Grammy winning R&B group, TLC), Michele Bond (Deputy Assistant Secretary for the US State Dept.), Dixie Bickel (Director of God’s Little Angels Orphanage in Haiti)

Ethiopian Adoption “Forever Day”


February 24, 2007 was the day we met our three children in Ethiopia. Due to US Visa complications, we were unable to bring our daughter home at that time. We brought our two sons home first. Two months later when our daughter’s Visa was approved, Russ returned to Ethiopia, to bring her home. In celebration we have created this slideshow. Postscript: Following the creation of this slideshow, we completed the adoption of another daughter, whom we met and fell in love with on the same day, February 24, 2007 at our daughter’s orphanage. We returned to Ethiopia and brought her home on August 10, 2008. Music: “And Now My Lifesong Sings” by Casting Crowns (www.castingcrowns.com), a band that daily rocks our kitchen and inspires us. www.onethankfulmom.com

Vision Shopsters: The Future of Orphan Disease Therapeutics – Market Forecasts to 2015, Pipeline Analysis and Reimbursement

The leading business intelligence provider, has released its latest research “The Future of Orphan Diseases Therapeutics – Market Forecasts to 2015, Pipeline Analysis and Reimbursement” The report provides in-depth analysis of unmet needs, drivers and barriers that impact the global orphan diseases therapeutics market. The report analyzes the markets for orphan diseases therapeutics in the US, the top five countries in Europe (the UK, Germany, France, Italy and Spain) and Japan. Treatment usage patterns, sales, and price are forecast until 2015 for the key geographies as well as select therapeutic segments. Further, the report provides competitive benchmarking for the leading companies and also analyzes the mergers, acquisitions and licensing agreements that shape the global markets.

http://www.visionshopsters.com/product/1247/The-Future-of-Orphan-Disease-Therapeutics-Market-Forecasts-to-2015-Pipeline-Analysis-and-Reimbursement.html

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.

Scope

The scope of this report includes:
– Annualized market data for the orphan diseases therapeutics market from 2000 to 2008, forecast forward to 2015
– Analysis of the leading therapeutic segments. These include Fabry Disease, Pompe Disease and Mucopolysaccharidosis.
– Analysis of the orphan diseases therapeutics market in the leading geographies of the world, which include the US, the UK, Germany, France, Italy, Spain, and Japan
– Market characterization of the orphan diseases therapeutics market including market size, annual cost of therapy, and treatment usage patterns
– Key drivers and barriers that have a significant impact on the market
– Coverage of pipeline molecules in various phases of drug development
– Competitive benchmarking of leading companies. The key companies studied in this report are F.Hoffmann-La Roche, Genzyme Corporation, Novartis AG, Celgene Corporation, Orphan Europe, Pfizer Inc, Actelion Pharmaceuticals and Shire Plc.
– Key M&A activities, licensing agreements, that have taken place between 2008 and 2009 in the global orphan diseases therapeutics market

Reasons to buy

The report will enhance your decision making capability. It will allow you to
– Align product portfolio to the markets with high growth potential
– Develop market-entry and market expansion strategies by identifying the leading therapeutic segments and geographic markets poised for strong growth
– Reinforce R&D pipelines by identifying new target mechanisms which can produce first in class molecules with more efficiency and better safety
– Develop key strategic initiatives by understanding key focus areas of leading companies
– Exploit in-licensing and out-licensing opportunities by identifying products that could fill portfolio gaps

Companies Mentioned

F.Hoffmann-La Roche
Genzyme Corporation
Novartis AG
Celgene Corporation
Orphan Europe
Pfizer Inc
Actelion Pharmaceuticals
Shire Plc.

Table Of Contents :

 

1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Global Orphan Disease Market : Introduction
2.1 Disease Overview
2.1.1 The United States
2.1.2 Europe
2.1.3 Japan
2.2 Report Guidance
2.3 Market Overview
3 Global Orphan Disease Therapeutics Market : Market Characterization
3.1 Market Forecasts
3.2 Orphan Drugs by Disease Sectors
3.3 Usage Patterns
3.3.1 Diseased Population
3.3.2 Treatment Seeking Population
3.3.3 Diagnosis Population
3.3.4 Prescription Population
3.3.5 Therapeutic Usage Patterns
3.4 Geographical Distribution
3.4.1 Market Drivers
3.4.2 Market Restraints
3.5 Key Market Trends
3.5.1 Increase in Federal Funding
3.5.2 Product Pipeline
3.5.3 Regulatory trends – Current Pricing and Reimbursement Scenario
4 Global Fabry Disease Therapeutics Market
4.1 Market Overview
4.2 Market Forecasts
4.3 Average Cost of Therapy
4.4 Usage Patterns
4.4.1 Diseased Population
4.4.2 Treatment Seeking Population
4.4.3 Diagnosis Population
4.4.4 Prescription Population
4.4.5 Therapeutic Usage Patterns
4.5 Product Analysis
4.5.1 Fabryzyme
4.5.2 Replagal
4.6 Drug Pipeline Analysis
5 Global Pompe Disease Therapeutics Market
5.1 Market Overview
5.2 Market Forecasts
5.3 Average Cost of Therapy
5.4 Usage Patterns
5.4.1 Diseased Population
5.4.2 Treatment Seeking Population
5.4.3 Diagnosis Population
5.4.4 Prescription Population
5.4.5 Therapeutic Usage Patterns
5.5 Product Analysis
5.5.1 Myozyme
5.6 Pipeline
6 Global Mucopolysaccharidosis VI Disease Therapeutics Market
6.1 Market Overview
6.2 Market Forecasts
6.3 Average Cost of Therapy
6.4 Usage Patterns
6.4.1 Diseased Population
6.4.2 Treatment Seeking Population
6.4.3 Diagnosis Population
6.4.4 Prescription Population
6.4.5 Therapeutic Usage Patterns
6.5 Product Analysis
6.5.1 Naglazyme
7 The US Orphan Disease Therapeutics Market
7.1 Market Overview
7.2 Market Forecasts
7.3 Usage Patterns
7.3.1 Diseased Population
7.3.2 Treatment Seeking Population
7.3.3 Diagnosis Population
7.3.4 Prescription Population
7.3.5 Therapeutic Usage Patterns
8 Europe Orphan Disease Therapeutics Market
8.1 Market Overview
8.2 Market Forecasts
8.3 Usage Patterns
8.3.1 Diseased Population
8.3.2 Treatment Seeking Population
8.3.3 Diagnosis Population
8.3.4 Prescription Population
8.3.5 Therapeutic Usage Patterns
9 Japan Orpahn Disease Therapeutics Market
9.1 Market Overview
9.2 Market Forecasts
9.3 Usage Patterns
9.3.1 Diseased Population
9.3.2 Treatment Seeking Population
9.3.3 Diagnosis Population
9.3.4 Prescription Population
9.3.5 Therapeutic Usage Patterns
10 Global Orphan Disease Therapeutics Market : Competitive Landscape
10.1 Overview
10.2 Competitor Profiling
10.2.1 Genzyme Corporation
10.2.2 Celgene Corporation
10.2.3 Actelion Pharmaceuticals
10.2.4 Shire Pharmaceuticals
10.2.5 AstraZeneca
10.2.6 Boehringer Ingelheim
10.2.7 Bristol-Myers Squibb
10.2.8 GlaxoSmithKline (GSK)
10.2.9 Novartis
10.2.10 Pfizer
10.2.11 Eli Lilly
10.2.12 Sanofi Aventis
10.2.13 UCB Pharma
10.2.14 Wyeth
11 Pipeline Analysis
11.1 Autoimmune Disorders
11.1.1 Cellcept
11.1.2 Pirfenidone
11.1.3 Rituxan
11.2 Genetic Disorders
11.2.1 Denufosol tetrasodium inhalation solution(INS37217)
11.2.2 Bronchitol(Mannitol)
11.2.3 Catena (Idebenone)
11.3 Infectious Diseases
11.3.1 XP-28 (xepol)
11.4 Neurology
11.4.1 Cladribine
11.4.2 Clazosentan (Pivlaz®)
11.5 Respiratory Disorders
11.6 Transplantation
11.7 Cardiovascular Disorders
11.7.1 ISIS 301012(Mipomersen sodium)
11.8 Cancer
11.8.1 Avastin
11.8.2 Enzastaurin
11.8.3 Patupilone
11.8.4 Zactima
11.8.5 Genasense
11.8.6 Ipilimumab (MDX-010, MDX-101)
11.9 Blood Cancer
11.10 Skin Cancer
11.11 Other Disorders
12 Global Orphan Disease Therapeutics Market: Strategic Consolidations
12.1 Mergers and Acquisitions
12.1.1 Genzyme Corp. and Bioenvision, Inc.
12.1.2 ViroPharma and Lev Pharmaceuticals
12.1.3 Biovitrum and Swedish Orphan
12.1.4 Shire plc and Zymenex A/s
12.2 Licensing Agreements
12.2.1 Overview
12.2.2 Drug Discovery & Preclinical
12.2.3 Phase I
12.2.4 Phase I
12.2.5 Phase III
12.2.6 Approved
13 Appendix
13.1 Market Definitions
13.2 Key Support Data
13.3 Abbreviations
13.4 Research Methodology
13.4.1 Coverage
13.4.2 Secondary Research
13.4.3 Primary Research
13.4.4 Forecasts
13.5 Expert Panel Validation
13.6 Contact Us
13.7 Disclaimer

To know more about this report & to buy a copy please visit :
http://www.visionshopsters.com/product/1247/The-Future-of-Orphan-Disease-Therapeutics-Market-Forecasts-to-2015-Pipeline-Analysis-and-Reimbursement.html

Contact us:

Visionshopsters
Ph : 91-22-40583000
Emailid: marketing@visionshopsters.com
Website : www.visionshopsters.com

Visionshopsters specializes in providing comprehensive collection of online market research reports, events bookings, country reports, company profiles, latest books and magazines, customized research services offering informative solutions worldwide. We constantly believe in providing inventive solutions to clients all across the globe. Our clientele consists of over thousands of top most academic organizations, financial institutions, trading companies, legal service providers, accounting consultancies and other corporate business executives.

Opportunities In Orphan Drugs: Strategies For Developing Maximum Returns From Niche Indications

 A 1984 modification to the ODA defined an Orphan Disease as any condition affecting fewer than 200,000 people in the US. The US was followed by both Japan and the EU which have also introduced their own orphan drug legislation in 1993 and 2000 respectively.

Industry has responded to this call for action and the FDA has approved over 270 orphan drugs in the US whilst there are another 583 listed in the Medtrack database as being in ongoing development. This has been motivated by the special incentives provided by the FDA and the EU including enhanced market exclusivity, research grants and tax incentives.

Orphan drugs present opportunities to pharma companies looking to move into more niche indications and away from mass market indications that have very low levels of clinical unmet need. Although there are many successful orphan drugs that have made large profits for their developers (Gleevec, NovoSeven etc) the development of these products must be approached carefully. This report uses a mixture of case studies and data from secondary sources to elucidate the key issues in the development of orphan drugs and ways to navigate them.

Key features of this report

• Overview of orphan drugs legislation in the US, EU, Japan and Australia including details of key incentives for developers and history of orphan designations and approvals.

• Evaluation of clinical trial and approval strategies including data on current clinical trial designs and strategies to maximize the chances of clinical trial success through the use of adaptive clinical trials.

• Overview of orphan drug reimbursement issues in both the US and the EU including details of the importance of the UK’s NICE and the development of novel risk sharing agreements.

• Examination of the role being played in orphan drug development by leading players in the pharmaceutical and biotech industry and the motivations behind this.

Scope of this report

• Gain an understanding of key orphan drugs legislation and the incentives available to the developers of drugs which successfully gain orphan designation.

• Get a quick overview of the overall orphan drug development pipeline in the EU and US.

• Gain strategic insight into the key differences between the development of orphan drugs and non-orphan drugs including the importance of patient advocacy groups.

• Discover key strategies to maximize revenues from orphan drugs through gaining market access and broadening the product label.

Key Market Issues

• Gaining orphan designation for a product confers access to various incentives. Once a product is granted orphan designation its developers gain a variety of incentives including extended market exclusivity, tax credits and research grants. These incentives have motivated the development of hundreds of products for orphan indications in the US, EU and Japan.

• The move away from reliance on blockbuster products towards niche indications is driving heightened interest in orphan drugs from companies of all sizes Orphan drugs lie at the opposite spectrum to blockbuster drugs and present Big Pharma with opportunities to enter specialist niche markets. Although on first analysis orphan drugs should not be particularly interesting to the pharma industry on account of their limited patient potential, by 2006 there were 50 orphan products with sales in excess of $200m of which 19 were blockbuster products and it is this which sustains the pharma industry’s interest in developing orphan drugs.

• Cancer continues to have the largest number of pipeline orphan drugs. This is largely motivated by the nature of cancer which allows it to be stratified into niche sub-diseases which qualify as orphan diseases. Developing orphan drugs for cancer indications makes additional sense as it presents opportunities to gain access to further orphan indications which have a similar disease mechanism.

Key findings from this report

• The developers of orphan drugs receive several incentives from the governments of countries that grant orphan status including extended market exclusivity, fast track assessment, research grants and tax incentives.
• There are 583 orphan drugs in active development with Cancer being the leading indication for which they are being developed with over 100 products in active development in the US alone.
• The development of an orphan drug is often a strategy pursued by small biotech and pharma companies with a view to licensing the product out in the later stages of development as part of an exit strategy. One example of this is PharmaMar’s development of Yondelis which has involved a complex network of partnerships as a source of both funding and expertise.

Key questions answered

• What is the key legislation concerning orphan drugs in the US, Japan and the EU?
• What incentives are available to the developers of orphan drugs in the US, Japan and the EU?
• What is the involvement of leading pharmaceutical companies in the development of orphan drugs?
• Why are orphan drugs an attractive proposition for pharmaceutical companies looking to expand their product portfolios?
 
 
  Table of Contents : 
Table of Contents
Opportunities in orphan drugs
Executive summary 8
Orphan drug legislation 8
The orphan drug pipeline 9
Orphan drug development trends and strategies 10
Orphan drug strategies 11
Chapter 1 Orphan drug legislation 14
Summary 14
Introduction 15
Orphan drug legislation in the US 15
Orphan drugs act 1983 15
Orphan drug designation 16
Orphan grant program 18
Orphan drug legislation in the EU 19
The Committee for Orphan Medicinal Products 19
Orphan designation process 20
EU incentives for orphan medicinal product developers 20
Orphan drug legislation in Japan 21
Incentives for orphan drug developers in Japan 22
Orphan drug legislation in Australia 23
Incentives for orphan drug developers in Australia 23
Chapter 2 The orphan drug pipeline 26
Summary 26
Introduction 27
Oncology 29
Istodax – romidepsin 29
Yondelis – trabectedin 30
Omapro – omacetaxine 33
Clolar – clofarabine 34
Onrigin – laromustine 35
TM601 36
EGEN – 001 37
Central nervous system 38
Zenas – amifampridine 38
H P Acthar Gel 39
ITI111 – midazolam 42
Respiratory and pulmonary systems 43
Surfaxin 43
Anti-infectives 44
Cayston – aztreonam lysine 44
ABthrax – raxibacumab 46
Autoimmune and inflammation 48
EN 101 48
Genetic diseases and dysmorphic syndromes 49
Uplyso – taliglucerase alfa 49
Chapter 3 Orphan drug development trends and issues 54
Summary 54
Introduction 55
Clinical trial and approval strategies for orphan drugs 55
Adaptive clinical trials in orphan drug development 58
The role of patient advocacy groups 62
Patient group/industry R&D partnerships 63
Orphan drug reimbursement issues 64
Orphan drug access in the US 65
Orphan drug access in the EU 65
Pharmaceutical risk-sharing agreements 70
Chapter 4 Orphan drug strategies 74
Summary 74
Introduction 75
The move towards niche indications 75
Opportunities in orphan drugs 76
Small pharma and biotech 77
Big pharma and established biotech 78
Pfizer 78
GlaxoSmithKline 82
Novartis 83
Sanofi-Aventis 85
Roche 86
Johnson & Johnson 88
Merck & Co 89
Eli Lilly 90
Bayer 91
Orphan drug specialists 92
Genzyme 92
Actelion 94
Strategies for sales growth for orphan drugs 96
Expansion into non-orphan indications 97
Expansion into further orphan indications 98
Using biomarkers to develop orphan drugs 101
Conclusion 104
Glossary 105
Index 106

List of Figures
Figure 1.1: Number of products receiving orphan designation in the US, 1984-December 2009 16
Figure 1.2: Number of Orphan drug approvals in the US, 1990-2008 17
Figure 1.3: Average NDA approval time, (months), 1995-2008 18
Figure 2.4: Therapeutic focus of products given orphan designation in the EU, 2009 27
Figure 2.5: Therapeutic focus of products given orphan designation in the US, 2009 28
Figure 2.6: Yondelis deals and alliances structure 32
Figure 2.7: EGEN-001 mode of action 38
Figure 2.8: Licensing deals for H P Acthar Gel 41
Figure 3.9: Blinding in US orphan drug trials, 2009 57
Figure 3.10: Randomization in US orphan drug trials, 2009 57
Figure 3.11: Comparators in US orphan drug trials, 2009 58
Figure 3.12: Reasons for adopting adaptive clinical trials 60
Figure 3.13: Overview of strategic considerations when designing adaptive clinical trials 61
Figure 3.14: Overview of operational considerations when designing adaptive trials 62
Figure 3.15: Relationship between annual cost of treatment (€) per patient and prevalence 69
Figure 3.16: The relationship between cost-effectiveness and societal value 70
Figure 4.17: Blockbuster to orphan drugs 75
Figure 4.18: Required conditions for stratified medicine 102

List of Tables
Table 1.1: Comparison of orphan drug systems 24
Table 2.2: Yondelis orphan designations 30
Table 2.3: Surfaxin’s US orphan designations by date 43
Table 3.4: Recent deals involving CFF and pharma companies 64
Table 4.5: Pfizer’s orphan designations since 2003 79
Table 4.6: Pfizer’s active orphan programs 79
Table 4.7: GlaxoSmithKline’s marketed US orphan drug portfolio 82
Table 4.8: GlaxoSmithKline’s active orphan programs 82
Table 4.9: Novartis’ marketed US orphan drug portfolio 84
Table 4.10: Novartis’s active orphan programs 84
Table 4.11: Sanofi-Aventis’s active orphan programs 86
Table 4.12: Roche’s marketed US orphan drug portfolio 86
Table 4.13: Roche’s active orphan programs 87
Table 4.14: J&J’s marketed US orphan drug portfolio 88
Table 4.15: J&J’s active orphan programs 89
Table 4.16: Merck & Co’s active orphan programs 90
Table 4.17: Eli Lilly’s marketed US orphan drug portfolio 90
Table 4.18: Eli Lilly’s active orphan programs 90
Table 4.19: Bayer’s marketed US orphan drug portfolio 91
Table 4.20: Genzyme’s global marketed orphan product portfolio ($m), 2008 92
Table 4.21: Genzyme’s lysosomal storage disorder product history 94
Table 4.22: Actelion’s global marketed portfolio ($m), 2008 95
Table 4.23: Actelion’s product pipeline 96
Table 4.24: Gleevec’s US orphan indications 99
Table 4.25: Nutropin’s US orphan indications 100
Table 4.26: Orphan designated products with at least one associated clinically validated biomarker 103 
 

 

For More information please contact :

http://www.aarkstore.com/reports/Opportunities-in-Orphan-Drugs-Strategies-for-developing-maximum-returns-from-niche-indications-38033.html

Orphans of Apollo

Product Description
ORPHANS OF APOLLO is the award winning documentary that has been called the greatest space story never told. The film ORPHANS OF APOLLO, tells the extraordinary true story of a small group of entrepreneurs who felt, ‘orphaned’ by President Nixon s decision to end the NASA Apollo Moon program and the subsequent years of nominal space activity. This band of brothers took matters into their own hands, and commandeered the Russian Mir Space Station, behind the backs of NASA and the US government. The rebellious, yet pioneering efforts has been credited with launching the new commercial Space Revolution. This is the remarkable untold story of the greatest secret in the new space race. This dramatic tale chronicles the adventure of the boldest business plan the Earth has ever seen. ‘MirCorp’, the entrepreneurial company s vision to transform the Russian space station into an outpost for what was intended to be the first phase of a trillion dollar business. The project was to include mining of asteroids, gravity free laboratories, a space ‘hotel’, and a research facility. MirCorp was the ultimate start-up company, and unlike anything the universe had ever seen. Join this band of rebels out to change the course of history in space, as they board a private jet, fly to Russia, negotiate one of the most remarkable business deals of the final frontier. Follow this diverse group as they pioneer their way through this new business of space. Listen to the management team as they struggle with issues of branding, finance, technology, and engage in the ultimate slugfest with the most powerful governments and bureaucrats. ORPHANS OF APOLLO is an intimate and compelling epic which eloquently communicates the real origins of the private commercial new space revolution. Now for the first, and possibly the last, time, ORPHANS OF APOLLO combines archival material from original NASA film footage, Russian archival footage, personal footage, IMAX footage, with interviews and or footage with key players including Tom Clancy, Elon Musk, Richard Branson, Rick Tumlinson, Walt Anderson, Gus Gardellini, Jeff Manber, and others. ABOUT FREE RADICAL PRODUCTIONS Free Radical Productions is a privately held production company headed by Michael Potter. The production company s current documentary project is profiling how post graduate students at the Singularity University are attempting to find a solution on how to have a positive impact on 1 billion people in the next decade.

Orphans of Apollo