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Dublin, May 12, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Global Regenerative Medicine Market Analysis & Forecast to 2021 - Stem Cells, Tissue Engineering, BioBanking & CAR-T Industries" report to their offering. Current regenerative medicine market is worth $18.9 billion globally, and will hit over $53 billion by 2021 According to the report ‘due to the dominance of the bone and joint reconstruction market, the US currently has the biggest space, followed by Europe. However, due to recent positive legislation in Japan and Europe, the stem cell arena will grow more substantially in these regions over the next five years. By 2021, it is possible that Europe will surpass the US market with respect to stem cell applications, and this will become more likely if the Trump Administration restricts legislation and funding’. The regenerative medicine market has massive scope and can be applied to a wide range of diseases and indications including neurological, autoimmune, cardiovascular, diabetes, musculoskeletal, ocular, orthopedic and wound healing. To that end, the expanse of market opportunities is large as are the patient populations globally. Kelly indicates that ‘this study has extensively profiled all major players in the market, analyzed their financials, pipeline products and business strategy going forward. It is the most comprehensive analysis on the market, and stakeholders wanting to gain a significant insight would greatly benefit from this information’. Financial forecasts to 2021 are included with respect to: Interestingly, the report also takes a detailed look at the CAR-T industry and its impact on the healthcare space. The CAR-T industry is addressing unmet needs in specific relapsed cancers, however does early clinical trial data support a blockbuster status for this upcoming therapy? The report also addresses the following key points: Key stakeholder questions are answered in this 680 page analysis including: Key Topics Covered: 1.0 Report Synopsis 1.1 Objectives of Report 1.2 Executive Summary 1.2 Key Questions Answered in this Report 1.3 Data Sources and Methodology 2.0 Introduction 2.1 Gurdon and Yamanaka Share the Nobel Prize 2.2 Stem Cell Clinical Trials: Initiated in 2010 2.3 Types of Stem Cells 2.4 Adult (Tissue) Stem Cells 2.5 Pluripotent Stem Cells 2.6 Somatic Cell Nuclear Transfer (SCNT) 2.7 Induced pluripotent Stem Cells (iPSC) 2.8 Mesenchymal Cells 2.9 Hematopoietic Stem and Progenitor Cells 2.10 Umbilical Cord Stem Cells 2.11 Heart Stem Cells 2.12 Mammary Stem Cells 2.13 Neural Stem Cells 2.14 Stem Cell Applications in Retinal Repair 2.15 Liver Stem Cells 2.16 Gut Stem Cells 2.16 Pancreatic Stem Cells 2.17 Epidermal Stem Cells 3.0 Stem Cells and Clinical Trials 3.1 Introduction 3.2 Pluripotent Stem Cells 3.3 Limbal Stem Cells 3.4 Neural Stem Cells 3.5 Endothelial Stem or Progenitor Cells 3.6 Placental Stem Cells 3.7 Why Do Stem Cell Clinical Trials Fail? 3.8 What is the Future of Stem Cell Trials? 3.9 Cutting Edge Stem Cell Clinical Trials 3.10 Ocata Therapeutics Current Stem Cell Trials 3.11 CHA Biotech Current Stem Cell Trials 3.12 Pfizer Current Stem Cell Trials 3.13 GSK Current Stem Cell Trials 3.14 Bayer Current Stem Cell Trials 3.15 Mesoblast International Current Stem Cell Trials 3.16 Millennium Pharmaceutical Current Stem Cell Trial 3.17 AstraZeneca Current Stem Cell Trials 3.18 Merck Current Stem Cell Trials 3.19 Chimerix Current Stem Cell Trials 3.20 Eisai Current Stem Cell Trials 3.21 SanBio Current Stem Cell Trials 3.22 Celgene Current Stem Cell Trials 3.23 StemCells Current Stem Cell Trials 3.24 Genzyme (Sanofi) Current Stem Cell Trials 3.25 Teva Current Stem Cell Trials 3.26 MedImmune Current Stem Cell Trials 3.27 Janssen Current Stem Cell Trials 3.28 Seattle Genetics Current Stem Cell Trials 3.29 Baxter Healthcare Current Stem Cell Trials 3.30 InCyte Corp Current Stem Cell Trials 4.0 Stem Cells, Disruptive Technology, Drug Discovery & Toxicity Testing 4.1 Introduction 4.2 Case Study: Genentech and Stem Cell Technology 4.3 3D Sphere Culture Systems 4.4 Stem Cells and High Throughput Screening 4.5 Genetic Instability of Stem Cells 4.6 Comprehensive in Vitro Proarrhythmia Assay (CiPA) & Cardiomyocytes 4.8 Coupling Precise Genome Editing (PGE) and iPSCs 4.9 Stem Cells & Toxicity Testing 4.10 Stem Cell Disease Models 4.11 Defining Human Disease Specific Phenotypes 4.12 Advantages of Stem Cell Derived Cells & Tissues for Drug Screening 5.0 Stem Cell Biomarkers 5.1 Pluripotent Stem Cell Biomarkers 5.2 Mesenchymal Stem Cell Biomarkers 5.3 Neural Stem Cell Biomarkers 5.4 Hematopoietic Stem Cell Biomarkers 6.0 Manufacturing Stem Cell Products 6.1 Manufacturing Strategies For Stem Cell Products 6.2 BioProcess Economics for Stem Cell Products 6.3 Capital Investment 6.4 Cost of Goods 6.5 Bioprocess Economic Drivers & Strategies 6.6 hPSC Expansion & Differentiation using Planar Technology 6.7 hPSC Expansion using 3D Culture 6.8 Microcarrier Systems 6.9 Aggregate Suspension 6.10 Bioreactor Based Differentiation Strategy 6.11 Integrated hPSC Bioprocess Strategy 6.12 GMP Regulations and Stem Cell Products 7.0 Investment & Funding 7.1 What do Investors Want from Cell & Gene Therapy Companies? 7.2 What Makes a Good Investment? 7.3 What Types of Companies do Not Get Investment? 7.4 Global Funding 7.5 Cell & Gene Therapy Investment Going Forward 7.6 What Cell & Gene Companies are the Most Promising in 2017? 7.7 Insights into Investing in Cell and Gene Therapy Companies 8.0 Regenerative Medicine Market Analysis & Forecast to 2021 8.1 Market Overview 8.2 Global Frequency Analysis 8.3 Economics of Regenerative Medicine 8.4 Market Applications & Opportunities for Regenerative Therapies 8.5 Global Financial Landscape 8.6 Regenerative Medicine Clinical Trial Statistics 8.7 Regenerative Medicine Market Forecast to 2021 8.8 Regenerative Medicine Geographic Analysis and Forecast to 2021 8.9 Regenerative Medicine Geographical Location of Companies 8.10 Regenerative Medicine Technology Breakdown of Companies 8.11 Commercially Available Regenerative Medicine Products 8.12 Major Regenerative Medicine Milestones 9.0 Stem Cell Market Analysis & Forecast to 2021 9.1 Autologous & Allogenic Cell Market Analysis 9.2 Stem Cell Market by Geography 9.3 Stem Cell Market Forecast by Therapeutic Indication 9.4 Stem Cell Reagent Market Trends 10.0 Tissue Engineering Tissue Engineering Market Analysis and Forecast to 2021 10.1 Geographical Analysis and Forecast to 2021 10.2 Geographical Analysis by Company Share 10.3 Tissue Engineering Clinical Indication Analysis & Forecast to 2021 11.0 Biobanking Market Analysis 11.1 Increasing Number of Cord Blood Banks Globally 11.2 Global Biobanking Company Sector Analysis & Breakdown 11.3 Allogenic Versus Autologous Transplant Frequency 11.4 Biobanking Market Analysis & Forecast to 2021 11.5 Major Global Players 12.0 Global Access & Challenges of the Regenerative Medicine Market 12.1 Regenerative Medicine Market in the USA 12.2 Regenerative Medicine in Japan 12.3 Regenerative Medicine in China 12.4 Regenerative Medicine in South Korea 13.0 Cell and CAR T Therapy 13.1 Challenges Relating to Cell therapy and Chimeric Antigen Receptor T Cells in Immunotherapy 13.2 Regulations Pertaining to Immunotherapy, including Adoptive Cell Therapy (CAR-T and TCR) Immunotherapy Regulation in the USA 13.3 Regulations for Cell Therapy & Immunotherapy in Japan 13.4 European Regulation and Cell Therapy & Immunotherapeutics 13.5 Manufacturing of Immunotherapies 13.6 Supply Chain & Logistics 13.7 Pricing & Cost Analysis 14.0 Company Profiles 14.1 Astellas Institute for Regenerative Medicine (Ocata Therapeutics) 14.2 Athersys 14.3 Baxter International (Baxalta, Shire) 14.4 Caladrius Biosciences (NeoStem) 14.5 Cynata Therapeutics 14.6 Cytori Therapeutics 14.7 MEDIPOST 14.8 Mesoblast 14.9 NuVasive 14.10 Osiris Therapeutics 14.11 Plasticell 14.12 Pluristem Therapeutics 14.13 Pfizer 14.14 StemCells Inc 14.15 STEMCELL Technologies 14.16 Takara Bio 14.17 Tigenix 15.0 SWOT Industry Analysis For more information about this report visit http://www.researchandmarkets.com/research/ml94n2/global


The advent of biologic disease-modifying anti-rheumatic drugs (DMARD) has boosted the rheumatoid arthritis (RA) market tremendously over the last two decades. The South-East Asia market, which for the purposes of this report comprises South Korea, Singapore, Taiwan, Malaysia, the Philippines, Thailand, Vietnam, and Indonesia, is forecast to grow at a compound annual growth rate (CAGR) of 4.7%, from USD1.04 Billion in 2015 to USD1.44 Billion in 2022. South Korea accounted for most of the market in 2015 with a 29.9% share, followed by Malaysia with 19.0%, the Philippines with 14.2%, Vietnam with 9.4%, Taiwan with 8.5%, Indonesia with 7.1%, Singapore with 6.4%, and Thailand with 5.5%. The entry of new therapies over the forecast period will stimulate market growth. Promising pipeline candidates include Eli Lilly and Incyte's baricitinib, Regeneron's sarilumab, GlaxoSmithKline (GSK) and Johnson & Johnson's sirukumab, Astellas' peficitinib (ASP015K), and AbbVie's upadacitinib. Galapagos' filgotinib is in late-stage development, but it will not be launched during the forecast period, as its Phase III trial completion date is in Q3 2020. The therapeutic market for RA has become extremely competitive owing to the number of new drug approvals. Competition for tumor necrosis factor alpha (TNF-a) inhibitors is particularly fierce and now dominates the treatment market for RA patients who are refractory to first-line DMARDs. In 2015, Humira (adalimumab), MabThera/Rituxan (rituximab) and Remicade (infliximab) were ranked among the top-10 best-selling drugs in the world, with global revenue of USD14.01 Billion, USD7.33 Billion and USD6.56 Billion, respectively, reflecting their groundbreaking clinical and commercial success. For more information about this report visit http://www.researchandmarkets.com/research/lz7tz7/rheumatoid Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/rheumatoid-arthritis-therapeutics-in-south-east-asia-markets-to-2022---extremely-competitive-owing-to-the-number-of-new-drug-approvals---research-and-markets-300456301.html


The global market is projected to display a robust growth represented by a CAGR of 4.96% during 2016- 2021, chiefly driven by large number of drugs in pipeline, rising number of chronically ill patients, new reforms and regulations in the consumption of medical cannabis. Over the recent years, the global pain management drugs industry has been growing rapidly with the increasing demand for drugs which are used for the treatment of chronic pain conditions of neck, lower back, shoulders, post-operative pain, and pain during the sports injuries. Globally, the growth in the pain management drugs market is driven by large number of chronically ill patients, rise in global incidences of cancer and strong presence of pipeline drugs used for chronically ill conditions. The report intends to provide cutting-edge market intelligence and help decision makers take sound investment evaluation. Besides, the report also identifies and analyses the emerging trends along with major drivers, challenges and opportunities in the global food service equipment market. Additionally, the report also highlights market entry strategies for various companies across the globe. Scope of the Report Global Market (Actual Period: 2011-2015, Forecast Period: 2016E-2021F) - Pain Management Drugs Market - By Type of Drugs - Application Market - Drug Pipeline - By Developer, Phase, Indication and Status - Pain Management Drugs Market - By Type of Drugs Other Report Highlights - Market Dynamics - Trends, Drivers, Challenges - Policy and Regulation - Company Analysis - Endo Pharmaceuticals, AstraZeneca, Novartis , Purdue Pharma, GSK, Tetra Bio Pharma, Allergen, Boehringer-Ingelheim, Sanofi, Pfizer Key Topics Covered: 1. Research Methodology 2. Executive Summary 3. Strategic Recommendation 4. Pain Management Drugs Market Outlook 5. Global Pain Management Drugs Market: Growth and Forecast 6. Global Pain Management Drugs Market: By Region 7. North America Pain Management Drugs Market 8. North America Pain Management Drugs Market, By Country 9. North America Pain Management Drugs Market: By Type 10. Europe Pain Management Drugs Market 11. Europe Pain Management Drugs Market, By Country 12. Europe Pain Management Drugs Market: By Type 13. Asia Pacific Pain Management Drugs Management Market 14. Asia Pacific Pain Management Drugs Market, By Country 15. Asia Pacific Drug Pain Management Market: By Type 16. Latin America Pain Management Drugs Market 17. Latin America Pain Management Drugs Market, By Country 18. Latin America Pain Management Drugs Market: By Type 19. ROW Pain Management Drugs Market 20. Market Dynamics 21. Company Profiles 22. Pipeline Analysis Companies Mentioned For more information about this report visit http://www.researchandmarkets.com/research/9lrmgv/global_pain To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-pain-management-drugs-market-analysis-2011-2017--2021-abuse-deterrent-opioids-will-create-new-growth-opportunities-300455318.html


News Article | May 10, 2017
Site: marketersmedia.com

— Growing demand for fiber supplements to overcome nutrition deficiency and increasing health consciousness among the people are the drivers propelling the market growth. Moreover change in life style requires more fiber nutrients to balance the diet is another prominent factor driving the market growth. However stringent regulatory approvals are hindering the market growth. Insoluble fiber in product segment is anticipated to move with a highest CAGR during forecast period owing to maintenance of balanced PH by consuming these kinds of fibers. Fruits and vegetables in source segment accounted for the largest market share in 2015, cereals and grains segment is expected to show healthy growth rate during forecast period. North America accounted for the highest market share as compared to other regions. The Asia Pacific region is expected to grow at a higher CAGR and is anticipated to account for the highest market share during forecast period owing to increase in disposable incomes. Some of the key players in the market include Archer Daniels Midland Company (ADM), Cargill, Incorporated, Danisco, E. I. Dupont De Nemours and Company, GlaxosmithKline(GSK), Grain Processing Corporation, Ingredion Incorporated, J. Rettenmaier & Söhne GmbH & Co. Kg, Novartis, Novus International, Procter and Gamble, Roquette Frères Company, Royal DSM, Sas Nexira, Südzucker AG Company, Sunopta, Inc. And Tate & Lyle PLC Company. Products Covered: • Soluble o Pectin o Inulin o Beta-Glucan o Polydextrose o Other Solubles • Conventional • Insoluble o Resistant Starch o Lignin o Chitin o Chitosan o Hemicellulose o Cellulose o Other Insoluble • Novel Regions Covered: • North America o US o Canada o Mexico • Europe o Germany o France o Italy o UK o Spain o Rest of Europe • Asia Pacific o Japan o China o India o Australia o New Zealand o Rest of Asia Pacific • Rest of the World o Middle East o Brazil o Argentina o South Africa o Egypt What our report offers: - Market share assessments for the regional and country level segments - Market share analysis of the top industry players - Strategic recommendations for the new entrants - Market forecasts for a minimum of 6 years of all the mentioned segments, sub segments and the regional markets - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations) - Strategic recommendations in key business segments based on the market estimations - Competitive landscaping mapping the key common trends - Company profiling with detailed strategies, financials, and recent developments - Supply chain trends mapping the latest technological advancements We offer wide spectrum of research and consulting services with in-depth knowledge of different industries. We are known for customized research services, consulting services and Full Time Equivalent (FTE) services in the research world. We explore the market trends and draw our insights with valid assessments and analytical views. We use advanced techniques and tools among the quantitative and qualitative methodologies to identify the market trends. Our research reports and publications are routed to help our clients to design their business models and enhance their business growth in the competitive market scenario. We have a strong team with hand-picked consultants including project managers, implementers, industry experts, researchers, research evaluators and analysts with years of experience in delivering the complex projects. For more information, please visit http://www.strategymrc.com/


Les avis de ces personnes atteintes de lupus sont inclus dans le « Lupus Knows No Boundaries e-Report » (Rapport électronique Le lupus ne connaît pas de frontières), développé par le biais d'une collaboration entre la WLF et GlaxoSmithKline (GSK) pour la Journée mondiale du lupus (le 10 mai). Le rapport réunit des expériences directes de personnes souffrant de lupus, de leurs défenseurs et de ceux qui les soignent. Le rapport est disponible dans son intégralité à l'adresse worldlupusday.org. « J'ai tout d'abord eu l'occasion de connaître le lupus à travers mon amie d'enfance, Lucy Vodden, pour qui la chanson Lucy in the Sky with Diamonds a été écrite », a déclaré Julian Lennon, photographe, auteur, musicien, philanthrope et ambassadeur mondial de la Lupus Foundation of America. « Ce sont les épreuves de Lucy qui m'ont ouvert les yeux sur le fardeau dévastateur que fait peser le lupus sur des millions d'individus et leurs familles. » Shannon Boxx a été membre de l'équipe nationale féminine de football des États-Unis, remportant trois médailles d'or olympiques avant sa retraite en 2015. Mais pendant la plus grande partie de sa carrière, elle a secrètement porté le poids d'un diagnostic de lupus. « J'ai décidé de parler publiquement du lupus, car je suis fatiguée de le cacher. J'étais à un point de ma carrière où je savais que je n'allais probablement pas jouer plus longtemps et j'ai eu le sentiment d'avoir une réelle responsabilité, occupant la scène publique, de parler du lupus et de sensibiliser davantage », a déclaré Boxx. « Nous appelons chacun à s'unir et à agir au nom de ceux affectés par le lupus », a déclaré Sandra C. Raymond, présidente et administratrice générale de la Lupus Foundation America qui œuvre en tant que secrétariat de la World Lupus Federation. « En mettant en lumière le lupus, nous avons l'assurance que les amis et la famille, les professionnels de soins de santé, les employeurs, les représentants du gouvernement, les assureurs maladie et les sociétés pharmaceutiques sont conscientes et informées des nombreux et divers défis auxquels sont confrontées les personnes souffrant de lupus. » « Le rapport électronique et les résultats du sondage Twitter montrent qu'il est possible de faire davantage pour susciter une prise de conscience, pour comprendre et pour établir des priorités de cette maladie débilitante, ainsi que pour donner confiance aux patients afin qu'ils parlent de l'impact de leurs symptômes », a déclaré le Dr Alex Liakos, Affaires médicales mondiales, GSK. « Chez GSK, nous sommes ravis d'avoir pu collaborer avec la World Lupus Federation et sommes impatients de continuer à apporter le soutien dont ont besoin ceux vivant avec le lupus dans de futures campagnes. » À propos du rapport électronique Le « Lupus Knows No Boundaries e-Report », a été créé conjointement par la World Lupus Federation et GSK dans le cadre d'un éventail d'activités de collaboration coordonnées autour de la Journée mondiale du lupus de cette année, dans le but de sensibiliser davantage sur l'impact global du lupus, de corriger les idées fausses du public concernant la maladie et de permettre à la communauté du lupus de prendre des mesures pour contribuer à répondre aux besoins de ceux vivant avec le lupus.


Estas opiniones de gente que padece lupus están incluidas en el informe "Lupus Knows No Boundaries e-Report" (informe electrónico: el lupus no conoce fronteras), elaborado gracias a la colaboración entre WLF y GlaxoSmithKline (GSK) para el Día Mundial de Lupus (10 de mayo). El informe reúne experiencias de primera mano de personas que padecen lupus, sus defensores y aquellos que se encargan de su tratamiento. El informe se encuentra disponible en su totalidad en worldlupusday.org. "La primera vez que supe del lupus fue a través de mi amiga de la infancia, Lucy Vodden, que fue quien inspiró la canción Lucy in the Sky with Diamonds", afirmó Julian Lennon, fotógrafo, autor, músico, filántropo y embajador internacional de la Fundación Americana de Lupus. "Fue la lucha de Lucy la que me abrió los ojos e hizo que me diera cuenta de lo devastadora que es la carga del lupus para millones de personas y sus familias".


News Article | September 14, 2017
Site: news.europawire.eu

LONDON, 14-Sep-2017 — /EuropaWire/ — GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted unanimously that the data support the efficacy and safety of Shingrix for the prevention of herpes zoster (shingles) in adults ages 50 and over. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. Dr. Emmanuel Hanon, Senior Vice President and Head of Vaccines R&D for GSK said: “Shingles is a painful and potentially serious condition. The risk of developing shingles increases with age and it is estimated that up to one in three people in the United States will develop shingles. Today’s vote brings us one step closer to approval of Shingrix, which is specifically designed to overcome age-related weakening of the immune system.” The Biologics License Application (BLA) was submitted to the FDA in October 2016. GSK’s shingles candidate vaccine is not currently approved for use anywhere in the world. Regulatory filings in the European Union, Canada, Australia and Japan are underway. About the candidate vaccine The candidate vaccine is a non-live, recombinant subunit vaccine to help prevent herpes zoster (shingles) and its complications, such as postherpetic neuralgia, in adults 50 years of age and older. The candidate vaccine combines an antigen, glycoprotein E, and an adjuvant system, AS01 , intended to generate a strong and long-lasting immune response that can help overcome the decline in immunity as people age.[i] The name “Shingrix” has not yet been approved for use by any regulatory authority. About shingles Shingles is caused by varicella zoster virus (VZV), the same virus that causes chickenpox.[ii]Nearly all older adults have the VZV dormant in their nervous system, waiting to reactivate with advancing age.[iii] As people age, the cells in the immune system lose the ability to mount a strong and effective response to infection.[iv] Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face. The pain is often described as aching, burning, stabbing or shock-like. Following the rash, a person can also experience postherpetic neuralgia (PHN), pain lasting from at least three months up to several years.2 PHN is the most common complication of shingles, occurring in up to 30 percent of all shingles cases.[v] There are an estimated 1 million cases of shingles in the United States each year.2 Incidence rates are similar throughout North America, Europe and Asia-Pacific regions.5 Older adults and those with conditions that compromise the immune system have the greatest risk for developing shingles. More than 99.5 percent of those over 50 years old are infected with VZV and one in three Americans will develop shingles in their lifetime. The risk increases to one in two for adults aged 85 years and older.2,[vi] GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D ‘Principal risks and uncertainties’ in the company’s Annual Report on Form 20-F for 2016.


News Article | September 15, 2017
Site: news.europawire.eu

LONDON, 14-Sep-2017 — /EuropaWire/ — GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) voted unanimously that the data support the efficacy and safety of Shingrix for the prevention of herpes zoster (shingles) in adults ages 50 and over. FDA Advisory Committees provide non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. Dr. Emmanuel Hanon, Senior Vice President and Head of Vaccines R&D for GSK said: “Shingles is a painful and potentially serious condition. The risk of developing shingles increases with age and it is estimated that up to one in three people in the United States will develop shingles. Today’s vote brings us one step closer to approval of Shingrix, which is specifically designed to overcome age-related weakening of the immune system.” The Biologics License Application (BLA) was submitted to the FDA in October 2016. GSK’s shingles candidate vaccine is not currently approved for use anywhere in the world. Regulatory filings in the European Union, Canada, Australia and Japan are underway. About the candidate vaccine The candidate vaccine is a non-live, recombinant subunit vaccine to help prevent herpes zoster (shingles) and its complications, such as postherpetic neuralgia, in adults 50 years of age and older. The candidate vaccine combines an antigen, glycoprotein E, and an adjuvant system, AS01 , intended to generate a strong and long-lasting immune response that can help overcome the decline in immunity as people age.[i] The name “Shingrix” has not yet been approved for use by any regulatory authority. About shingles Shingles is caused by varicella zoster virus (VZV), the same virus that causes chickenpox.[ii]Nearly all older adults have the VZV dormant in their nervous system, waiting to reactivate with advancing age.[iii] As people age, the cells in the immune system lose the ability to mount a strong and effective response to infection.[iv] Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face. The pain is often described as aching, burning, stabbing or shock-like. Following the rash, a person can also experience postherpetic neuralgia (PHN), pain lasting from at least three months up to several years.2 PHN is the most common complication of shingles, occurring in up to 30 percent of all shingles cases.[v] There are an estimated 1 million cases of shingles in the United States each year.2 Incidence rates are similar throughout North America, Europe and Asia-Pacific regions.5 Older adults and those with conditions that compromise the immune system have the greatest risk for developing shingles. More than 99.5 percent of those over 50 years old are infected with VZV and one in three Americans will develop shingles in their lifetime. The risk increases to one in two for adults aged 85 years and older.2,[vi] GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D ‘Principal risks and uncertainties’ in the company’s Annual Report on Form 20-F for 2016.


Dr. Emmanuel Hanon, Senior Vice President and Head of Vaccines R&D for GSK said: "Shingles is a painful and potentially serious condition. The risk of developing shingles increases with age and it is estimated that up to one in three people in the United States will develop shingles. Today's vote brings us one step closer to approval of Shingrix, which is specifically designed to overcome age-related weakening of the immune system." The Biologics License Application (BLA) was submitted to the FDA in October 2016. GSK's shingles candidate vaccine is not currently approved for use anywhere in the world. Regulatory filings in the European Union, Canada, Australia and Japan are underway. About the candidate vaccine The candidate vaccine is a non-live, recombinant subunit vaccine to help prevent herpes zoster (shingles) and its complications, such as postherpetic neuralgia, in adults 50 years of age and older. The candidate vaccine combines an antigen, glycoprotein E, and an adjuvant system, AS01 , intended to generate a strong and long-lasting immune response that can help overcome the decline in immunity as people age.1 The name "Shingrix" has not yet been approved for use by any regulatory authority. About shingles Shingles is caused by varicella zoster virus (VZV), the same virus that causes chickenpox.2 Nearly all older adults have the VZV dormant in their nervous system, waiting to reactivate with advancing age.3 As people age, the cells in the immune system lose the ability to mount a strong and effective response to infection.4 Shingles typically presents as a rash, with painful blisters across the chest, abdomen or face. The pain is often described as aching, burning, stabbing or shock-like. Following the rash, a person can also experience postherpetic neuralgia (PHN), pain lasting from at least three months up to several years.2 PHN is the most common complication of shingles, occurring in up to 30 percent of all shingles cases.5 There are an estimated 1 million cases of shingles in the United States each year.2 Incidence rates are similar throughout North America, Europe and Asia-Pacific regions.5 Older adults and those with conditions that compromise the immune system have the greatest risk for developing shingles. More than 99.5 percent of those over 50 years old are infected with VZV and one in three Americans will develop shingles in their lifetime. The risk increases to one in two for adults aged 85 years and older.2,6 GSK – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com. 1 The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes. 2 Harpaz, et al. MMWR Recomm Rep. 2008; 57(5): 1-30. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices. 3 Gnann, et al. N Eng J Med. 2002; 347(5): 340-6. Clinical practice. Herpes zoster. 4 Gruver, et al. J Pathol. 2007: 211(2): 144-56. Immunosenescence of ageing. 5 Kawai, et al. BMJ Open. 2014; 4(6). Systematic review of incidence and complications of herpes zoster: towards a global perspective. 6 Cohen, et al. N Eng J Med. 2013; 369: 255-263. Herpes Zoster.


Kwong K.,GSK | Carr M.J.,GSK
Current Opinion in Pharmacology | Year: 2015

Voltage-gated sodium channels play a key role in the transmission of sensory information about the status of organs in the periphery. Sensory fibers contain a heterogeneous yet specific distribution of voltage-gated sodium channel isoforms. Major efforts by industry and academic groups are underway to develop medicines that interrupt inappropriate signaling for a number of clinical indications by taking advantage of this specific distribution of channel isoforms. This review highlights recent advances in the study of human channelopathies, animal toxins and channel structure that may facilitate the development of selective voltage-gated sodium channel blockers. © 2015 Elsevier Ltd.

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