European Pharmaceutical Review

JULY 20, 2022

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 Six products were withdrawn or revoked for safety reasons during the study period.

Medicine 97

Medicine Safety Side effects Electronics 97

European Pharmaceutical Review

JULY 5, 2022

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

Patients Food and Drug Administration Side effects Safety 104

European Pharmaceutical Review

MAY 20, 2024

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

Patients Medical Safety Healthcare 122

Clarify Health

MAY 27, 2022

The plan should define enrollment goals for underrepresented racial and ethnic participants, indicate the potential safety or efficacy differences among these participants, and outline the plan to collect data and explore differences between subgroups.

FDA 52

FDA Food and Drug Administration Recruitment Transportation 52

Clarify Health

MAY 27, 2022

The plan should define enrollment goals for underrepresented racial and ethnic participants, indicate the potential safety or efficacy differences among these participants, and outline the plan to collect data and explore differences between subgroups. Get valuable Insights delivered to your inbox.

FDA 52

FDA Food and Drug Administration Recruitment Transportation 52

European Pharmaceutical Review

SEPTEMBER 22, 2023

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.

Food and Drug Administration 97

Food and Drug Administration Safety Patients Leads 97

European Pharmaceutical Review

DECEMBER 14, 2023

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

Medicine Safety Competition Medical 116

PM360

MAY 15, 2023

In addition, IBM will be preparing Moderna’s scientists to use its technology, with the company participating in the IBM Quantum Accelerator program and the IBM Quantum Network through which access to IBM’s quantum computing systems can assist Moderna in exploring life sciences use cases powered by quantum technologies.

Safety 52

Safety Healthcare Healthcare Electronics 52

European Pharmaceutical Review

APRIL 8, 2025

15 This includes network security and cybersecurity measures to protect sensitive data and prevent breaches, but also for data protection compliance with regional and applicable laws and regulations. Chemical Engineering Science, 2016; 149, 42-50. Robust IT security and infrastructure is a strict necessity for large organisations.

Manufacturing 52

Manufacturing Food and Drug Administration Management Pharmaceutical 52