Tag Archives: Drug Regulation

New Cancer Drugs Often Bestow Little Benefit Regarding Survival or Wellbeing? (NHS Choices / BMJ)

Posted on October 15, 2017 by Dementia and Elderly Care News

Summary A quotation from the authors’ abstract may say it all: “This systematic evaluation of oncology approvals by the European Medicines Agency (EMA) in 2009-13 shows that most drugs entered the market without evidence of benefit on survival or quality … Continue reading →

Posted in Commissioning, For Doctors (mostly), For Nurses and Therapists (mostly), For Social Workers (mostly), In the News, International, Management of Condition, NHS Digital (Previously NHS Choices), Pharmacological Treatments, Quick Insights, Statistics, Systematic Reviews, UK, Universal Interest | Tagged Advanced Melanoma: Improving Survival Rates, Assessment of Quality of Life, Bazian, Behind the Headlines, Better Regulation, Big Pharma, BMJ Publishing Group Ltd, British Medical Journal (BMJ), Cancer, Cancer Drugs Approved by EMA (2009-13), Cancer Drugs Approved on Basis of Surrogate End Points, Cancer Drugs Fund (CDF), Cancer Pharmaceuticals (New Approvals), Cancer Research, Cancer Survival, Cancer Survival Group: London School of Hygiene and Tropical Medicine, Cancer Treatment (Newer Drugs), Combination Nivolumab Plus Ipilimumab, Department of Global Health and Social Medicine: King's College London, Department of Health Policy: London School of Economics and Political Science, Department of Health Services Research and Policy: London School of Hygiene and Tropical Medicine, Drug Regulation, EMA: European Medicines Agency, European Medicines Agency, European Medicines Agency (Cancer Drug Approvals), European Medicines Agency (EMA), European Public Assessment Reports (EPARs), European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS), European Society for Medical Oncology's Magnitude of Clinical Benefit Scale (MCBS), Evidence Versus Mythology, Faculty of Pharmacy: Riga Stradins University, Institute of Cancer Policy: King's College London, Kings College London, Latvia, London, London School of Economics and Political Science, London School of Hygiene and Tropical Medicine, London School of Hygiene and Tropical Medicine (LSHTM), LSE Health: London School of Economics and Political Science, LSHTM: London School of Hygiene and Tropical Medicine, Market Approval (New Cancer Drugs), Myth-Busting, Myths and Misconceptions About New Cancer Drugs, New Cancer Drug Approvals (EMA), Pharmaceutical Industry, Pharmaceutical Regulators, Pharmaceuticals, Quality of Life, Regulatory Experts, Regulatory Requirements, Regulatory Stringency, Regulatory System, Riga Stradins University (Latvia), Skin Cancer, Surrogate End Points Versus Subsequent Efficacy / Survival, Thinking Like a Patient and Acting Like a Taxpayer | Leave a comment

Dementia Discovery Fund Launched (WDC / ARUK)

Posted on November 18, 2015 by Dementia and Elderly Care News

Summary The Dementia Discovery Fund (DDF) was launched on October 21st 2015. Full Text Link Reference Launch of Dementia Discovery Fund. London [Online]: World Dementia Council (WDC), November 10th 2015. See also: Full Text Link Reference $100m Dementia Discovery Fund … Continue reading →

Posted in Alzheimer’s Research UK, Charitable Bodies, Commissioning, Department of Health, For Doctors (mostly), For Nurses and Therapists (mostly), For Researchers (mostly), In the News, International, Management of Condition, Mental Health, Models of Dementia Care, National, Pharmacological Treatments, Quick Insights, UK, Universal Interest | Tagged $100m Dementia Discovery Fund, Ageing and Dementia, Ageing and Society, Ageing Population, Alzheimer's Research UK, Alzheimer’s Research UK (ARUK), Andrew Plump: Chief Medical and Scientific Officer at Takeda Pharmaceutical Company Limited, ARUK: Alzheimer’s Research UK, Big Pharma, Biogen, Biopharmaceutical Companies, Collaboration, Collaborative Projects, Cross-Sector Partnerships, Dementia Discovery Fund, Dementia Discovery Fund (DDF), Dementia Research, Dementia Research Funding, Disease Modifying Treatment by 2025 (Aim), Disease-Modifying Therapies, Disease-Modifying Therapies for Dementia, Dr Jan Lundberg: President of Lilly Research Laboratories, Dr Matthew Norton: Alzheimer's Research UK, Drug Discovery Programmes, Drug Identification, Drug Regulation, Drug-Development Pipeline, Eli Lilly Inc., Eli Lilly’s UK Dementia Research Centre, First Global Ministerial Conference on Global Action Against Dementia, First WHO Ministerial Conference on Global Action Against Dementia, G8 Dementia Summit: Global Action Against Dementia, GlaxoSmithKline, Global Action Against Dementia, Global Action Against Dementia (GAAD), Global Ministerial Conference on Global Action Against Dementia (WHO), Global Outlook, Government Research Funding, GSK Johnson & Johnson, International Collaborations, International Programmes, Jane Ellison, Johnson & Johnson, Lilly, Mikael Dolsten: President of Worldwide Research and Development at Pfizer, Partnership, Partnership and Collaboration, Partnership Working, Patrick Vallance: President of Pharmaceuticals R&D at GSK, Paul Stoffels: Worldwide Chairman of Johnson & Johnson, Pfizer, Pfizer Inc., Pharmaceutical Industry, Research and Development, Research and Innovation, Research Commitment, Research Funding, SV Life Sciences, SV Life Sciences (SVLS), Takeda, WDC: World Dementia Council, World Dementia Council | Leave a comment

Challenges in Developing Disease-Modifying Treatments for Dementia (Department of Health)

Posted on July 23, 2015 by Dementia and Elderly Care News

Summary Raj Long, the Senior Regulatory Officer at the Bill & Melinda Gates Foundation, explores the problems in developing treatments for dementia. The independent “Finding a Path for the Cure for Dementia” report is a contribution to the G8 Dementia … Continue reading →

Posted in Charitable Bodies, Commissioning, Department of Health, For Doctors (mostly), For Nurses and Therapists (mostly), For Researchers (mostly), In the News, International, Management of Condition, Models of Dementia Care, Patient Care Pathway, Pharmacological Treatments, Quick Insights, Standards, UK, Universal Interest | Tagged Academia-Industry Partnerships, Academic Research, AIFA: Italian Medicines Agency, Attrition Analysis, BfArM: Federal Institute of Drugs and Medical Devices, BfArM: Federal Institute of Drugs and Medical Devices (Germany), Bill and Melinda Gates Foundation, Biopharmaceutical Companies, Burden of Dementia, Canada, CEOi: Global CEO Initiative on Alzheimer’s Disease, Challenge on Dementia (David Cameron), Charitable Funding, Clinical Trial Efficiencies, Collaboration, Collaborative Projects, Composite End Points, Consistent Global Development Pathways, Cross-Sector Partnerships, CTEG: Clinical and Technical Expert Group, Danish Health and Medicines Authority, Data Sharing, Dementia Challenge, Dementia Research, Dementia Research Funding, Dementia Research Priorities, Dementia Research: UK Impact, Denmark, Department of Health Dementia Challenge, Diagnosis and Referral, Disease Modifying Treatment by 2025 (Aim), Disease-Modifying Therapies, Disease-Modifying Therapies for Dementia, DKMA: Danish Health and Medicines Authority, Drug Discovery Programmes, Drug Identification, Drug Regulation, Drug-Development Pipeline, Eli Lilly Inc., Eli Lilly’s UK Dementia Research Centre, EMA: European Medicines Agency, European Medicines Agency, European Union, FIH: First in Humans, Financial Incentives, First Global Ministerial Conference on Global Action Against Dementia, Food and Drug Administration, G20 Countries, G7 Countries, G8 Dementia Summit: Global Action Against Dementia, G8 Summit, Gaps in the Basic Science, Germany, Global Alzheimer’s and Dementia Action Alliance (GADAA), Global Envoy for Dementia Innovation, Global Leadership, Global Outlook, Global Social Investment for Dementia, Government Research Funding, Health Canada, IAP Steering Committee, IDAP Steering Committee, IDAP: International Dementia Advisory Platform, IFPMA: International Federation of Pharmaceutical Manufacturers & Associations, Incentives and Investment, Incentives for Drug Development, Independent Safety Review Committee, Integrated Development Pathway, International Collaborations, International Dementia Advisory Platform (IDAP), International Dementia Research Inventories, International Programmes, Italian Medicines Agency, Italy, Japan, Japan: Pharmaceuticals and Medical Devices (Japan), Knowledge Translation, MEB: Medicines Evaluations Board, Medicines and Healthcare Products Regulatory Agency, Medicines Evaluation Board Netherlands, MHRA: Medicines and Healthcare Products Regulatory Agency, Modelling and Extrapolation, Multilateral Cooperation, Multilateral Regulator Cooperation, Netherlands, Neurodegeneration, Neurodegenerative Disease Research, Neurodegenerative Diseases, Neurodegenerative Disorders, Neurological Research, OHE: Office of Health Economics, Open Access Databases, Open Access Knowledge Resources, Open Access Research, Open Science, Organisation for Economic Co-operation and Development (OECD), Organisation for Economic Co-operation and Development (OECD) Countries, Organisation for Economic Cooperation and Development, Partnership, Partnership and Collaboration, Partnership Working, Patient Viewpoint, Philanthropic Funding, Pipeline Databases, PMDA: Pharmaceutical and Medicines Devices Agency, Public-Private Partnership (PPP), Quantifiable Reproducible Outcome Measures, Raj Long: Senior Regulatory Officer for Integrated Development in Global Health at the Bill & Melinda Gates Foundation, Reasons for Termination of Trials, Regulator Perspectives, Regulatory Agencies, Regulatory Experts, Research and Developers’ Status Quo, Research and Development, Research and Innovation, Research Commitment, Research Funding, Research Status Quo, Resource and Incentives, Risk Benefit Balance, Standardisation and Validation of Cognitive Endpoints, Swiss Medic, Switzerland, United States, WDC: World Dementia Council, World Dementia Council, World Health Organisation (WHO) | Leave a comment

International Meeting of Regulators on Challenges of Dementia Research and Drug Development (MHRA / Department of Health)

Posted on May 26, 2015 by Dementia and Elderly Care News

Summary The Medicines and Healthcare Products Regulatory Agency (MHRA) took part in an international workshop with other regulators, and has released a statement of intent about how to support the development of drugs for dementia. This work is in support … Continue reading →

Posted in Department of Health, For Doctors (mostly), For Researchers (mostly), International, Pharmacological Treatments, Quick Insights, World Health Organization (WHO) | Tagged Accelerating Alzheimer's Research and Drug Development, Attrition Analysis, Bill and Melinda Gates Foundation, Clinical Trial Efficiency, Composite End Points: Development of Standardised and Validated Endpoint Components, Coordinated Regulatory Action, Danish Health and Medicines Authority, Dementia Research, Department of Health’s Integrated Development Initiative, Disease Modifying Treatment by 2025 (Aim), Disease-Modifying Therapies, Disease-Modifying Therapies for Dementia, Drug Development for Alzheimer's Disease, Drug Regulation, Drug-Development Pipeline, European Medicines Agency, Expediting Regulatory Approval Procedures: Balancing Benefits and Risks, Federal Institute for Drugs and Medical Devices, First Global Ministerial Conference on Global Action Against Dementia, First WHO Ministerial Conference on Global Action Against Dementia, G7 Global Dementia Summit, G8 Dementia Summit, Global Alzheimer’s and Dementia Action Alliance (GADAA), Global Leadership, Global Ministerial Conference on Global Action Against Dementia (WHO), Global Outlook, Global Regulatory Efficiency and Consistency, Health Canada, Incentives, Incentives for Drug Development, International Federation of Pharmaceutical Manufacturers and Associations, Italian Medicines Agency, Market Failure (Dementia Research and Drug Development), Medicines and Healthcare Products Regulatory Agency, Medicines and Healthcare Products Regulatory Agency (MHRA), Medicines Evaluation Board, Multilateral Cooperation: Reducing Unnecessary Testing Replication and Methodology Testing, Office for Life Sciences, Pharmaceutical and Medicines Devices Agency (Japan), Pharmaceutical Regulators, Raj Long: Senior Regulatory Officer for Integrated Development in Global Health at the Bill & Melinda Gates Foundation, Regulation, Regulators, Regulatory Barriers, Regulatory Research Dementia Workshop, Regulatory System, Removing Regulatory Barriers, Research and Innovation, Resource and Incentives, Swissmedic, Translational Research, US Food and Drug Administration, WDC: World Dementia Council, WHO: World Health Organization, World Dementia Council | Leave a comment

Announcements From WHO’s First Ministerial Conference on Global Action Against Dementia Conference (Dementia Challenge / Department of Health / World Dementia Council / WHO / GAAD)

Posted on March 18, 2015 by Dementia and Elderly Care News

Summary Health Secretary Jeremy Hunt has announced a $100 million Dementia Discovery Fund at the World Health Organisation’s First Ministerial Conference on Global Action Against Dementia Conference. The Dementia Discovery Fund will be used to finance dementia research with the … Continue reading →

Posted in Acute Hospitals, Charitable Bodies, Commissioning, Community Care, Department of Health, Diagnosis, End of Life Care, For Carers (mostly), For Doctors (mostly), For Nurses and Therapists (mostly), For Researchers (mostly), For Social Workers (mostly), In the News, Integrated Care, International, Management of Condition, Mental Health, Models of Dementia Care, National, NIHR, Non-Pharmacological Treatments, Patient Care Pathway, Person-Centred Care, Pharmacological Treatments, Quick Insights, Standards, Statistics, UK, Universal Interest, World Health Organization (WHO) | Tagged $100m Dementia Discovery Fund, Ageing and Dementia, Ageing and Society, Ageing Population, Alzheimer's Research UK, Alzheimer’s Research UK (ARUK), ARUK: Alzheimer’s Research UK, Awareness Raising, Big Pharma, Biogen, Biopharmaceutical Companies, Burden of Dementia, Challenge on Dementia (David Cameron), Collaboration, Collaborative Projects, Cross-Sector Partnerships, Dementia Challenge, Dementia Diagnosis, Dementia Discovery Fund, Dementia Research, Disease Modifying Treatment by 2025 (Aim), Disease-Modifying Therapies, Disease-Modifying Therapies for Dementia, Dr Margaret Chan: WHO Director-General, Drug Discovery Programmes, Drug Identification, Drug Regulation, Drug-Development Pipeline, Eli Lilly Inc., Eli Lilly’s UK Dementia Research Centre, First Global Ministerial Conference on Global Action Against Dementia, First WHO Ministerial Conference on Global Action Against Dementia, Former Health Secretary Jeremy Hunt, G8 Dementia Summit: Global Action Against Dementia, GlaxoSmithKline, Global Action Against Dementia, Global Action Against Dementia (GAAD), Global Ministerial Conference on Global Action Against Dementia (WHO), Global Outlook, Government Research Funding, Human Rights, International Collaborations, International Programmes, Johnson & Johnson, JP Morgan, Knowledge Translation, Leadership, Lilly, Ms. Cathrin Petty: JP Morgan, OECD, Organisation for Economic Co-operation and Development (OECD), Organisation for Economic Co-operation and Development (OECD) Countries, Partnership, Partnership and Collaboration, Partnership Working, Pfizer, Pfizer Inc., Pharmaceutical Industry, Prime Minister’s Dementia Challenge, Quality of Care, Quality of Care and Support, Quality of Care for People With Dementia, Reducing Stigma, Research and Development, Research and Innovation, Research Commitment, Research Funding, Rt Hon Jeremy Hunt MP: Former Secretary of State for Health, WDC: World Dementia Council, World Dementia Council, World Health Organisation (WHO) | Leave a comment

Emerging Leaders In Dementia: Communiqué for the First WHO Ministerial Conference on Global Action Against Dementia (World Dementia Council)

Posted on March 15, 2015 by Dementia and Elderly Care News

Summary A group of “young leaders in dementia” will take part in the First Global Ministerial Conference on Global Action Against Dementia, which is to be hosted by the World Health Organisation (WHO) in Geneva on March 16th – 17th … Continue reading →

Posted in Acute Hospitals, Assistive Technology, Charitable Bodies, Commissioning, Community Care, Department of Health, Diagnosis, For Carers (mostly), For Doctors (mostly), For Nurses and Therapists (mostly), For Researchers (mostly), For Social Workers (mostly), In the News, Integrated Care, International, Management of Condition, Mental Health, Models of Dementia Care, Patient Care Pathway, Person-Centred Care, Pharmacological Treatments, Quick Insights, Standards, UK, Universal Interest, World Health Organization (WHO) | Tagged Ageing and Dementia, Ageing and Society, Ageing Population, American Association for the Advancement of Sciences, Awareness Raising, Burden of Dementia, Care Standards, Care Standards in Hospitals, Carer Experience, Carer's Experience of Dementia, Carers’ Experiences of the Dementia Journey, Center for Public Engagement with Science and Technology (the American Association for the Advancement of Sciences), Challenge on Dementia (David Cameron), Collaboration, Collaborative Projects, Cross Sector Working, Cross-Sector Partnerships, Dementia Challenge, Dementia Diagnosis, Dementia Grand Challenge Proposal (WDC or G7 Sponsorship for Jumpstarting Radical Breakthroughs in Prevention Cure and Care of Dementia)), Dementia Narrative (Qualitative Research), Dementia Research, Dementia-Friendly Communities, Dementia-Friendly Design, Dementia-Friendly Products, Disease Modifying Treatment by 2025 (Aim), Disease-Modifying Therapies, Disease-Modifying Therapies for Dementia, Disproportionate Burden of Dementia on Women, Drug Discovery Programmes, Drug Identification, Drug Regulation, Drug-Development Pipeline, Emerging Leaders In Dementia (aka Young Leaders in Dementia), Experiences, First Global Ministerial Conference on Global Action Against Dementia, First WHO Ministerial Conference on Global Action Against Dementia, G7 Countries, G7 Dementia Summit, G7 Global Dementia Summit, G8 Dementia Summit, G8 Dementia Summit: Global Action Against Dementia, GAAD: Global Action Against Dementia, Global Action Against Dementia, Global Action Against Dementia (GAAD), Global Dementia Framework, Global Ministerial Conference on Global Action Against Dementia (WHO), Global Outlook, Global Toolbox for Dementia Research (Proposal), Government Research Funding, Group of 7 (G7), Home Care Standards, Intergenerational Cohesion, Intergenerational Mingling, Intergenerational Relations, Intergenerational Solidarity, Intergenerational Work, International Collaborations, International Dementia-Friendly Symbol (Proposal), International Programmes, Interventions: Outcomes and Cost Savings, Knowledge Translation, Leadership, Lived Experience, London, Mobile Technology, Multi-Generational Approaches, Multisectoral Collaboration, OECD, One-Stop Shops, Organisation for Economic Co-operation and Development (OECD), Organisation for Economic Co-operation and Development (OECD) Countries, Ottawa, Outcomes and Monitoring, Outcomes Benchmarking, Partnership, Partnership and Collaboration, Partnership Working, Patient Experience, Personal Experience of Dementia, Prevalence of Dementia, Prevention, Prevention Programmes, Prime Minister’s Dementia Challenge, Purple Angel Logo, Quality of Care, Quality of Care and Support, Quality of Care for People With Dementia, Reducing Stigma, Research and Development, Research and Innovation, Research Commitment, Research Funding, Science and Innovation Network (SIN), Service User Experience, Social Care Standards, Stigma, Stigma of Dementia, Stigma-Free Environments, Tokyo, UK Science and Innovation Network, UK Science and Innovation Network (SIN), Voluntary and SME Sectors, Washington DC, Working With Professionals From Other Sectors, World Health Organisation (WHO), World Health Organisation (WHO) Regional Office for Europe, Young Leaders in Dementia (#YLDementia), Young Leaders in Dementia (Canada Japan USA Europe), Young Leaders in Dementia Group | Leave a comment

Global Ministerial Conference on Global Action Against Dementia (WHO / Department of Health / Dementia Challenge)

Posted on March 6, 2015 by Dementia and Elderly Care News

Summary The World Health Organisation (WHO) will stage the First Global Ministerial Conference on Global Action Against Dementia on March 16th – 17th 2015, in Geneva. This event will engage a larger number of countries in the international focus on … Continue reading →

Posted in Acute Hospitals, Commissioning, Community Care, Dementia Care Pathway Group, Department of Health, Diagnosis, For Carers (mostly), For Doctors (mostly), For Nurses and Therapists (mostly), For Researchers (mostly), For Social Workers (mostly), In the News, Integrated Care, International, Management of Condition, Mental Health, Models of Dementia Care, Non-Pharmacological Treatments, Northern Ireland, Patient Care Pathway, Person-Centred Care, Pharmacological Treatments, Quick Insights, Standards, Statistics, UK, Universal Interest, World Health Organization (WHO) | Tagged Ageing and Dementia, Ageing and Society, Ageing Population, Awareness Raising, Burden of Dementia, Challenge on Dementia (David Cameron), Collaboration, Collaborative Projects, Cross-Sector Partnerships, Dementia Alliance International, Dementia Challenge, Dementia Diagnosis, Dementia Research, Department of Health's Digital Health Blog, Digital Engagement, Disease Modifying Treatment by 2025 (Aim), Disease-Modifying Therapies, Disease-Modifying Therapies for Dementia, Dr Margaret Chan: WHO Director-General, Drug Discovery Programmes, Drug Identification, Drug Regulation, Drug-Development Pipeline, First Global Ministerial Conference on Global Action Against Dementia, G8 Dementia Summit, G8 Dementia Summit: Global Action Against Dementia, Global Action Against Dementia, Global Ministerial Conference on Global Action Against Dementia (WHO), Global Outlook, Government Research Funding, Human Rights, International Collaborations, International Programmes, Kate Swaffer: Chair of Dementia Alliance International, Knowledge Translation, Leadership, OECD, Organisation for Economic Co-operation and Development (OECD), Organisation for Economic Co-operation and Development (OECD) Countries, Partnership, Partnership and Collaboration, Partnership Working, Prescribed Disengagement, Prevalence of Dementia, Prevention, Prevention Programmes, Prime Minister’s Dementia Challenge, Quality of Care, Quality of Care and Support, Quality of Care for People With Dementia, Reducing Stigma, Rehabilitation in Dementia, Research and Development, Research and Innovation, Research Commitment, Research Funding, World Health Organisation (WHO), World Health Organisation (WHO) Regional Office for Europe | Leave a comment

Tag Archives: Drug Regulation

Dementia Discovery Fund Launched (WDC / ARUK)

International Meeting of Regulators on Challenges of Dementia Research and Drug Development (MHRA / Department of Health)

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