“Global Orphan Drug Market & Clinical Pipeline Insight 2023” Report Highlights:
• Clinical Insight on 800 Orphan Drugs
• Patent Insight, Orphan Designated Indication & Region/Country
• Marketed Orphan Drugs: More Than 300
• Maximum Orphan Designated Drugs in Phase-II: More Than 200
• Global Orphan Drug Designation Criteria
• FDA & EMA Guidelines
Overview of the regulatory system for medical devices in kenyaPaulyne Wairimu
The regulatory landscape for medical devices has in recent years witnessed changes. This presentation gives an overview of the changes and the anticipated phased registration process of Medical Devices in kenya as regulatory system strengthening is developed.
"Brief Introduction of China Food & Drug Administration" by Chang Yongheng, China Centre for Food and Drug International Exchange, China Food & Drug Administration
Overview of the regulatory system for medical devices in kenyaPaulyne Wairimu
The regulatory landscape for medical devices has in recent years witnessed changes. This presentation gives an overview of the changes and the anticipated phased registration process of Medical Devices in kenya as regulatory system strengthening is developed.
"Brief Introduction of China Food & Drug Administration" by Chang Yongheng, China Centre for Food and Drug International Exchange, China Food & Drug Administration
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
The clinical trial process is one of the most critical and necessary steps for the development of all new drugs,
biologics or medical devices. Conducting clinical trials in Japan requires a delicate balancing act between having a
thorough understanding of the Japanese regulatory framework, as well as having an even much better
understanding of how clinical trials must be managed within the nuances and boundaries of the Japanese culture.
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
Global orphan drug market future outlook 2020KuicK Research
"Global Orphan Drug Market Future Outlook 2020" report highlights:
Global Orphan Drug Market Overview
Global Orphan Drug Market Segment Analysis
FDA & EMA Regulation for Clinical Trials Orphan Designated Drugs
Orphan Drug Designation Criteria & Reimbursement Policy by Region
Comprehensive Insight on Global Orphan Drugs Clinical Pipeline & Patent Analysis by Company, Country, Indication & Phase
Global Orphan Drugs Clinical Pipeline: 697 Drugs
Majority Orphan Drugs in Phase-II Trials: 249 Drugs
Marketed Orphan Drugs: 274 Drugs
Global orphan drug market outlook 2018Rajesh Sarma
“Global Orphan Drug Market Outlook 2018” research report by KuicK Research comprehensive insight on following developments related to global orphan drug market:
Global & Regional Orphan Drug Market Overview
Orphan Drug Designation Criteria Across Key Markets
Market Specific Reimbursement Policy & Regulatory Framework
Orphan Drug Pipeline by Phase, Orphan Designated Disease & Country
Competitive Landscape
This presentation contains information about dossier preparation and submission as well as about CTD (Common Technical Document) which is an internationally agreed format for the preparation of applications regarding new drugs intended to be submitted to regional regulatory authorities in participating countries.
The clinical trial process is one of the most critical and necessary steps for the development of all new drugs,
biologics or medical devices. Conducting clinical trials in Japan requires a delicate balancing act between having a
thorough understanding of the Japanese regulatory framework, as well as having an even much better
understanding of how clinical trials must be managed within the nuances and boundaries of the Japanese culture.
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
Global orphan drug market future outlook 2020KuicK Research
"Global Orphan Drug Market Future Outlook 2020" report highlights:
Global Orphan Drug Market Overview
Global Orphan Drug Market Segment Analysis
FDA & EMA Regulation for Clinical Trials Orphan Designated Drugs
Orphan Drug Designation Criteria & Reimbursement Policy by Region
Comprehensive Insight on Global Orphan Drugs Clinical Pipeline & Patent Analysis by Company, Country, Indication & Phase
Global Orphan Drugs Clinical Pipeline: 697 Drugs
Majority Orphan Drugs in Phase-II Trials: 249 Drugs
Marketed Orphan Drugs: 274 Drugs
Global orphan drug market outlook 2018Rajesh Sarma
“Global Orphan Drug Market Outlook 2018” research report by KuicK Research comprehensive insight on following developments related to global orphan drug market:
Global & Regional Orphan Drug Market Overview
Orphan Drug Designation Criteria Across Key Markets
Market Specific Reimbursement Policy & Regulatory Framework
Orphan Drug Pipeline by Phase, Orphan Designated Disease & Country
Competitive Landscape
Global orphan drug market future outlook 2020Rajesh Sarma
"Global Orphan Drug Market Future Outlook 2020" report highlights:
Global Orphan Drug Market Overview
Global Orphan Drug Market Segment Analysis
FDA & EMA Regulation for Clinical Trials Orphan Designated Drugs
Orphan Drug Designation Criteria & Reimbursement Policy by Region
Comprehensive Insight on Global Orphan Drugs Clinical Pipeline & Patent Analysis by Company, Country, Indication & Phase
Global Orphan Drugs Clinical Pipeline: 697 Drugs
Majority Orphan Drugs in Phase-II Trials: 249 Drugs
Marketed Orphan Drugs: 274 Drugs
Introduction
Brief description of the drug and the therapeutic class to which it belongs
Chemical and pharmaceutical information
Animal Pharmacolog
Animal Toxicology
Human/Clinical Pharmacology phase I
Therapeutic exploratory trials (Phase II)
Therapeutic confirmatory trials (Phase III)
Special Studies Geriatrics, pediatrics, pregnant or nursing women
Regulatory status in other countries
Prescribing information
Samples and Testing Protocol/s
This New Drug Approval Process
The new drug approval process is a complex and rigorous process that pharmaceutical companies must go through in order to bring a new drug to market. The process is designed to ensure that new drugs are safe and effective for their intended use.
The new drug approval process typically takes several years to complete and involves the steps mentioned in presentation
“US Orphan Drug Market Outlook 2018” research report by KuicK Research comprehensive insight on following developments related to US orphan drug market:
US Orphan Drug Market Overview
Orphan Drug Designation Criteria
Market Specific Reimbursement Policy & Regulatory Framework
US Orphan Drug Pipeline by Phase, Indication & Originator
Marketed Orphan drug List by Indication & Brand Name
Key Issue to be Resolved
Competitive Landscape
Pharma Uptoday Monthly Magazine Volume 7 issue Oct 2014Sathish Vemula
To recap the previous month's pharma highlights to Pharma group, Monthly magazine Volume 7 has been released with
3 News Uptoday
30 New Guidance and New MAPP Release
37 Audit Findings
483 Observations
- 483 of Alexander Infusion
Warning Letters
- John W Hollis Inc.
EMA Non-Compliance Reports
- Hebei Dongfeng Pharmaceutical Co., Ltd, China
- I.C.I. International Chemical Industry, Italy
41 Regulations of the Month
§211.184 Component, drug product container, closure, and labeling records
Brazil OTC Pharmaceutical Market Report 2022 to 2030Insights10
This report presents a strategic analysis of Brazil's Over the Counter (OTC) Pharmaceuticals Market and a forecast for its development in the medium and long term. It provides a broad overview of the market dynamics, trends and insights, growth drivers and restraints, segmentation, competitive landscape, healthcare policies, and regulatory framework, reimbursement scenario, challenges, and future outlook. This is one of the most comprehensive reports about Brazil's Over the Counter (OTC) Pharmaceuticals Market, offering unmatched value, accuracy, and expert insights.
Mastering Regulatory Approval in New Orphan Drug MarketsLewis Lau
Presented at DIA 2015 Annual Meeting. A symposum titled "A Global Update on Orphan Drug" chaired by Mr Noriaki Murao
http://www.diaglobal.org/en-US/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/Find-Sessions-and-Presentations/Event-Details.aspx?productID=3803687&eventType=Symposium&title=A%20Global%20Update%20on%20Orphan%20Drugs
This symposium addresses the current status and forthcoming activities related to orphan drugs in North America, EU and Japan. Orphan drug development is considered essential in these regions, and the various provisions to accelerate the development of orphan drugs have been implemented. However, some challenges still remain for the companies and the agencies wishing to pursue development and approval of orphan drugs in these regions.
The safe use of medicines is perhaps the single most important criteria that any regulatory authority within a given country has to ensure in order both to protect the public health and the integrity of its health care system. For the same purpose pharmacovigilance was established. According to WHO, Pharmacovigilance is the science and activities related to the collection, detection, and assessment of ADR’s. It promotes the systematic, rational use and assures the confidence for the safety of drugs. It improves patient care and safety. Significance of pharmacovigilance is growing as the patients or consumers have become more responsive about the advantage and hazard of medicines. Pharmacovigilance is a complex process and a robust system is essential to undertake the activity. A good pharmacovigilance system will identify the hazard aspects in the short period of time. This review article tries to explain the some basic principles, history and developments, methods and some scope of this developing field i.e. Pharmacovigilance in India.
Primary biliary cholangitis (PBC) Epidemiology and Compitive landscape_Thelan...Thelansis
Thelansis known to provide therapy specific market insight reports which essentially covers Epidemiology and Market Forecast of 8 key markets (US, Germany, France, Spain, Italy, UK, Japan and China) in a advance excel based dynamic forecast model, enables client to understand the differnet scenario of the market over a period of 10 years.
Competitive landscape analysis covered in the Thelansis reports allows our clients to monitor competitor’s activity around targeted indications during a different phase of development (Early Phase, Phase I, II, and III) and post-approval phase.
Our services include epidemiology study, Market forecasting, clinical trial analytics, Pipeline assessment, enrollment projections, trialsite prioritization, investigator profiling, and trial completion date projection, launch date estimation, and essentially the key product positioning.
Thelansis reports now coupled with KOL insights gathered from the the Primary market research (PMR) through in-house programmed web-based survey tool which helps our clients to fill the gap of real-time data, unmet needs, and critical strategic insights right from development to commercialization.
Non alcoholic steatohepatitis - pipeline review, h1 2014Ambikabasa
This report provides comprehensive information on the therapeutic development for Non-Alcoholic Steatohepatitis, 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 Non-Alcoholic Steatohepatitis and special features on late-stage and discontinued projects.
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Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
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RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
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Global orphan drug market designation status clinical pipeline trials insight 2023
1. Global Orphan Drug Designation Status Database Market Clinical Pipeline Trials Insight 2023
“Global Orphan Drug Market & Clinical Pipeline Insight 2023” report gives comprehensive
insight on various clinical and non-clinical aspects associated with ongoing clinical trials of
808 orphan designated drugs across the globe. The in-depth clinical insight presented in the
report helps the reader to analyze and identify the various stakeholders involved in the
clinical development and commercialization of orphan designated drugs in the global market.
Currently there are more than 300 orphan designated drugs commercially available in the
global market and around 800 drugs in clinical development phase.
“Global Orphan Drug Market & Clinical Pipeline Insight 2023” Report Highlights:
Clinical Insight on 800 Orphan Drugs
Patent Insight, Orphan Designated Indication & Region/Country
Marketed Orphan Drugs: More Than 300
Maximum Orphan Designated Drugs in Phase-II: More Than 200
Global Orphan Drug Designation Criteria
FDA & EMA Guidelines
For Report Sample Contact: neeraj@kuickresearch.co or +91-11-47067990
1. Global Orphan Drug Market Overview
1.1 Market Overview
1.2 Global Orphan Drug Clinical Pipeline Overview
2. Global Orphan Drug Designation Criteria
2.1 US Food and Drug Administration (US FDA)
2.2 European Medicines Agency (EMA)
2.3 Japan
2.4 Taiwan
2.5 Korean Food and Drug Administration (KFDA)
2.6 Australia
Global Orphan Drug Clinical Pipeline by Company, Indication & Phase
3. Orphan Drug Development Phase: Unknown
3.1 Overview
2. 3.2 Clinical Pipeline Insight
4. Orphan Drug Development Phase: Research
4.1 Overview
4.2 Clinical Pipeline Insight
5. Orphan Drug Development Phase: Preclinical
5.1 Overview
5.2 Clinical Pipeline Insight
6. Orphan Drug Development Phase: Clinical
6.1 Overview
6.2 Clinical Pipeline Insight
7. Orphan Drug Development Phase: Phase-0
7.1 Overview
7.2 Clinical Pipeline Insight
8. Orphan Drug Development Phase: Phase - I
8.1 Overview
8.2 Clinical Pipeline Insight
9. Orphan Drug Development Phase: Phase - I/II
9.1 Overview
9.2 Clinical Pipeline Insight
10. Orphan Drug Development Phase: Phase - II
10.1 Overview
10.2 Clinical Pipeline Insight
11. Orphan Drug Development Phase: Phase - II/III
11.1 Overview
11.2 Clinical Pipeline Insight
12. Orphan Drug Development Phase: Phase - III
12.1 Overview
12.2 Clinical Pipeline Insight
13. Orphan Drug Development Phase: Preregistration
13.1 Overview
13.2 Clinical Pipeline Insight
14. Orphan Drug Development Phase: Registered
14.1 Overview
14.2 Clinical Pipeline Insight
15. Marketed Orphan Drug Clinical Insight by Company, Indication & Phase
15.1 Overview
15.2 Clinical Pipeline Insight
3. 16. Discontinued & Suspended Orphan Drugs in Clinical Pipeline by Company,
Indication & Phase
16.1 No Development Reported
16.2 Discontinued
16.3 Preregistration Submission Withdrawal
16.4 Marketed Withdrawal
16.5 Suspended
17. Competitive Landscape
17.1 AOP Orphan
17.2 Agenus
17.3 Alexion
17.4 Bristol Myers Squibb
17.5 Biogen Idec
17.6 Celgene
17.7 Eli Lilly
17.8 Genethon
17.9 Genzyme Corporation
17.10 Glaxosmithkline
17.11 Merck
17.12 Novartis Pharmaceuticals
17.13 Orphan Europe
17.14 Pfizer
17.15 Prosensa
17.16 Rare Disease Therapeutics
17.17 Roche
17.18 Sanofi
17.19 Shire
17.20 Teva Pharmaceutical
For Report Sample Contact: neeraj@kuickresearch.co or +91-11-47067990
Figure 1-1: Global Orphan Drugs Market Value (US$ Billion), 2016-2023
Figure 1-2: US - Orphan Drugs Market Value (US$ Billion), 2016-2023
Figure 1-3: Europe - Orphan Drugs Market Value (US$ Billion), 2016-2023
Figure 1-4: Asia* - Orphan Drugs Market Value (US$ Billion), 2016-2023
Figure 1-5: Global - Orphan Drug Clinical Pipeline by Phase (%), 2016 till
2023
Figure 1-6: Global - Orphan Drug Clinical Pipeline by Phase (Numbers), 2016
till 2023
Figure 1-7: Global - Orphan Drug Clinical Pipeline by Phase (%), 2016 till
2023
4. Figure 1-8: Global - Orphan Drug Clinical Pipeline by Phase (Numbers), 2016
till 2023
Figure 17-1: AOP Orphan
Figure 17-2: Agenus Pipeline
Figure 17-3: Genethon Drug Pipeline
Figure 17-4: Genzyme Drug Pipeline
Figure 17-5: Orphan Europe Pipeline
Figure 17-6: Prosensa Drug Pipeline
Figure 17-7: Shire Drug Pipeline