EMA has just published its latest report on real-world evidence studies to support medicine regulation. Some takeaways from the report: 📊 A total of 40 studies were conducted between February 2023 and February 2024. 🌐 The DARWIN EU network expanded from 10 to 20 data partners since 2023, allowing access to data from almost 130 million patients from 13 European countries - in full compliance with data protection legislation. 💉 13 studies informed vaccine safety and effectiveness, supporting the response to health crises like COVID-19 and Mpox. 🧠 One study examined the risk of suicide and self-harm in people using GLP-1 receptor agonists and helped EMA to conclude that the evidence does not support a causal association. 💊 For the first time, two studies looked at the demand and stock levels of critical human medicines, to better understand management and prevention of medicine shortages. Learn more from the infosheet below 👇 👇 👇 Link to the full report 🔗 https://lnkd.in/ddpnHFfg #RealWorldEvidence #BigData #DARWINEU
Thera-Business Inc.
Business Consulting and Services
Ottawa, Ontario 571 followers
Experts in Regulatory Documents
About us
Thera-Business has been involved in the development of evidence-based reports and regulatory documents for over 25 years. Our team of highly trained scientists and medical professionals would be pleased to help your company meet FDA and EU regulatory requirements. Throughout the last few years our team has grown and so have our services! We are proud to offer you the following: • Regulatory affairs • Comprehensive systematic literature reviews • Meta-analyses • Clinical study appraisals • Clinical evaluation reports • Clinical evaluation report remediation • Survey development We also offer other services on a case by case basis. Please contact us to discuss any healthcare research/regulatory projects you may need help with.
- Website
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https://www.therabusiness.com/
External link for Thera-Business Inc.
- Industry
- Business Consulting and Services
- Company size
- 11-50 employees
- Headquarters
- Ottawa, Ontario
- Type
- Privately Held
- Specialties
- Clinical Evaluation Reports, Health Technology Reports, Regulatory Documents, Clinical Regulatory Documentation, Research, Consulting, Medical Device Regulatory Documentation, Systematic Reviews, Meta-Analyses, and Health Surveys
Locations
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Primary
515 Legget Drive
Suite 204
Ottawa, Ontario K2K 3G4, CA
Employees at Thera-Business Inc.
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Isabella Steffensen
President at Thera-Business Inc.
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Vlad Kuznetsov
Director of Software Development at Thera-Business Inc. and DRUGDOCS
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Pranav Kumar
Senior Medical Writer / Researcher at Thera-Business Inc.
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Red Thaddeus Miguel
Vice-President and Chief Technology Officer at Thera-Business Inc. and DRUGDOCS® | Forty Under 40
Updates
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In a groundbreaking discovery, Columbia University researchers have identified a bacterial gene, called Neo, that defies the long-standing principles of molecular biology. Unlike traditional genes which exist on chromosomes, Neo is a free-floating, ephemeral gene produced by bacteria only when infected by a virus. This discovery could lead to a paradigm shift in our understanding of genetics and the role of ephemeral genes in various life forms. As scientists continue to explore this phenomenon, we may soon rethink some of the fundamental principles of biology. Read more about this discovery here: https://lnkd.in/gkbhuTEw Find the published research here: https://lnkd.in/gdrRpbSf #Neo #Genetics #Biotech #ScientificDiscovery
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🎓 Moderna teams up with Coursera to offer a free course on mRNA medicines! 🌍 To address the growing skills gap in STEM fields, Moderna has partnered with Coursera to offer a free, comprehensive course on mRNA medicines. The course provides an in-depth look at mRNA’s role in drug development and its vast potential in vaccines and therapies. By making this course accessible to everyone, Moderna is helping to democratize education in a critical field, supporting both current and aspiring medical professionals in their learning journey. Read more here: https://lnkd.in/ei_Pz2TU And find out more about the course here: https://lnkd.in/dCtbvvDD #mRNA #STEMEducation #Healthcare #BacktoSchool
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Boosting Early Cancer Detection with Routine Blood Tests. Researchers from University College London have uncovered that routine blood tests could significantly enhance early cancer diagnosis. Analyzing data from over 400,000 patients, who had visited a GP due to abdominal pain or bloating, they found that abnormal results in 19 common blood tests were associated with a higher risk of cancer within a year. This method could lead to a 16% increase in urgent referrals versus assessments based on symptoms, age, and sex for undiagnosed cancer, offering a more efficient and affordable strategy for early detection and improving the chances of successful treatment. Read more here: https://lnkd.in/ejwg5NNE And find the research paper here: https://lnkd.in/ejB-Xqtn #CancerResearch #HealthcareInnovation #EarlyDetection
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Get your health, medical science, and wellness info on the go! 🎧 Mayo Clinic Press, the publishing arm of the nation's leading hospital, is launching a new series of consumer-focused health and wellness podcasts. Covering a wide range of topics, from nutrition to children's health and aging. These podcasts offer listeners access to Mayo Clinic's world-renowned expertise, practical tips, and the latest in medical science. Whether you're seeking advice on a specific condition or looking to stay informed on general health topics, these podcasts are your gateway to Mayo Clinic’s unparalleled knowledge, making complex medical information accessible and actionable for everyday life. For more information go to: https://lnkd.in/etv_5hSp To listen visit: https://lnkd.in/eSq5TyX7 or wherever you listen to podcasts.
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AI Breakthrough: Predicting Disease a Decade in Advance. A groundbreaking study from The University of Edinburgh, in collaboration with Optima Partners and Biogen, has revealed that AI can predict the onset of diseases like Alzheimer's, heart disease, and type 2 diabetes up to ten years before diagnosis. By analyzing protein patterns in blood samples, researchers have achieved prediction accuracy beyond traditional risk factors. This discovery could open new avenues for early intervention and prevention, offering hope for millions affected by these conditions. While more work is needed to bring these insights into clinical practice, the foundation has been set for a new era in disease prediction and healthcare. Get more info here: https://lnkd.in/eV8H9sES Read the full paper in @Nature Aging here: https://lnkd.in/eZgiAaxw #AI #HealthcareInnovation #DiseasePrevention #EarlyDiagnosis #Alzheimers, #HeartDisease #T2D #Type2Diabetes
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Link Between Gut Microbes, High-Fat Diets, & Breast Cancer Growth Uncovered. A recent study has uncovered a critical connection between high-fat diets, specific gut bacteria, and the progression of breast cancer. Published in the Proceedings of the National Academy of Sciences (PNAS), the research found that a high-fat diet increases Desulfovibrio bacteria in the gut, which in turn suppresses the immune system and accelerates tumor growth. This groundbreaking discovery highlights how gut microbes, influenced by diet, can impact cancer development and may lead to new therapeutic approaches. As the most common malignancy affecting women worldwide, understanding these mechanisms is vital. This finding could pave the way for innovative cancer therapies. Read more here: https://lnkd.in/eFj8QdAr And find the publication here: https://lnkd.in/ew4me-6r #BreastCancer #GutHealth #CancerResearch
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EMA & Gates Foundation Back African Continental Drug Evaluation Pilot 🌍 The European Medicines Agency, in partnership with the Bill & Melinda Gates Foundation, is co-funding a 1 yr pilot program to establish continental medicines review procedures within the African Union. This program builds on over a decade of work toward creating the African Medicines Agency and is part of the broader African Medicines Regulatory Harmonization initiative. The pilot will see the AMRH Evaluation of Medicinal Products Technical Committee & the Good Manufacturing Practices Technical Committee acting as pre-regulatory agencies, evaluating the quality, safety, and efficacy of priority drugs. The results will inform regulatory policies to aid national authorities in authorizing products while enhancing cross-border information sharing. EMA and the European medicines regulatory network will continue to offer technical expertise and training to support the AMA’s establishment. This collaborative effort marks a significant step forward in strengthening Africa's pharmaceutical industry and regulatory capacity. Read more here: https://lnkd.in/e2q6qG7F #GlobalHealth #PharmaceuticalRegulation #Africa #EMA #GatesFoundation
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Celebrating 5 years with Sheldon Yu at Thera-Business! Your hard work, dedication, and passion have been instrumental in our success. Thank you, Sheldon, for your unwavering commitment and the value you bring to our team every day. Here’s to many more years of achievement together! #WorkAnniversary #TeamTheraBusiness #Gratitude
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Historic Lawsuit Highlights Ongoing Issues in Medical Research The family of Henrietta Lacks, whose cells were extracted without consent more than 70 years ago, has initiated a new lawsuit against Novartis and Viatris. The case highlights ongoing issues of exploitation in medical research. Henrietta Lacks' cancer cells are the source of the #HeLa cell line, the first immortalized human cell line, and one of the most important cell lines in medical research. They have been pivotal in numerous breakthroughs and were used extensively by these companies. The Lacks family is seeking compensation for the "stolen" cells and advocating for recognition of the injustices faced by Black individuals in medical research. This lawsuit follows previous legal actions against other pharma companies and underscores the need for accountability in the legacy of medical exploitation. Read more here: https://lnkd.in/eJuHc8yA #HenriettaLacks #EthicsInMedicine #PharmaceuticalResearch
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