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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. Our research showed that in Europe between 1999 and 2016, 35 products were withdrawn. But over time, trends in what evidence is most available and therefore most used, change.

Medicine 116
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How can evidence-based medicine (EBM) methodology support drug withdrawals?

European Pharmaceutical Review

Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. Monitoring and studying the side effects of licensed medicines is an essential part of drug development to ensure public safety. Six products were withdrawn or revoked for safety reasons during the study period.

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Why patient-centricity is essential to accelerate rare disease clinical research

European Pharmaceutical Review

5,6 Clinical trials are essential for the safety and efficacy of novel therapies to be established. In fact, one-quarter of rare disease trials between 2016 and 2020 were terminated due to low accrual rates. References European Commission. Public Health – Rare Diseases. Available at: [link] Wakap, et al.

Patients 122
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Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

The drug is recognised in several international clinical guidelines for use as monotherapy or combination treatment regimens for advanced gastric cancer, including the European Society for Medical Oncology (ESMO), 2 the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN). 5): V38-V49. Oncotarget.

Patients 104
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The Role of Blockchain Technology in Healthcare Data Security

Referral MD

Blockchain technology addresses patients’ and medical staff’s need for secure data recording, transmission, and consultation over networks. In 2016, US healthcare fraud cost $30 million. Blockchain will improve healthcare safety and transparency. Personalized medicine and wearables raise data protection concerns.

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The Use of Big Data in Pharmaceutical Marketing: Opportunities and Challenges

Pharma Marketing Network

Additionally, by analyzing data from completed clinical trials, companies can gain insights into the safety and effectiveness of their products, which can inform the development of new drugs. 1 (2016) 3. The post The Use of Big Data in Pharmaceutical Marketing: Opportunities and Challenges appeared first on Pharma Marketing Network.

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Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

7 It is currently being evaluated in a Phase Ib/IIa clinical study, demonstrating to date a good safety profile. While favourable safety has been reported up to the Phase II, the relevance of targeting the C-terminal portion of Abeta still needs to be confirmed. She is currently CEO and successfully led the IPO on Nasdaq in 2016.