Remove Medicine Remove Pharmacology Remove Safety
article thumbnail

Alzheimer’s drug requires strengthened pharmacovigilance approach

European Pharmaceutical Review

A paper published by the Drug Safety Research Unit (DSRU) in the British Journal for Clinical Pharmacology , has asserted the need for ongoing assessment of the safety and effectiveness of the Alzheimers drug lecanemab in the real-world clinical setting.

Safety 59
article thumbnail

MHRA Chief Executive to step down

European Pharmaceutical Review

The Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), Dame June Raine, will step down in the Autumn following five years in the role. While she is stepping down from her current role, Dame June shared that she still hopes to contribute “to patient safety and public health in other ways.”

Safety 111
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 6 Thus, it is critical to ensure the consistency of therapeutic effect across batches (see box).

Marketing 103
article thumbnail

The future of medical cannabis development in Europe

European Pharmaceutical Review

While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful. This will lead to a higher proportion of these medicines becoming licensed, benefitting a larger number of patients. 2023 Mar 4;16(3):257-66.

Medical 98
article thumbnail

Efficacy of novel drug proven in MDD study

European Pharmaceutical Review

The data “are compelling, particularly the significant improvements observed in both depressive and anhedonic symptoms,” stated Dr Roger S McIntyre, FRCPC, Professor of psychiatry and pharmacology, University of Toronto and Executive Director of the Brain and Cognition Discovery Foundation in Toronto, Canada.

article thumbnail

Why R&D innovation holds the key to greater patient impact

European Pharmaceutical Review

3 With greater scientific understanding of cancer, the industry has made significant progress in developing innovative medicines to help patients. However, access to these medicines is not close to meeting patient demand, creating inequalities in the health prospects of those diagnosed with cancer. 1,2 In the EU, an estimated 2.7

Patients 105
article thumbnail

How NLP Helps Life Sciences Companies Unlock Insights from Drug Labels

PM360

Drug labels hold value for life sciences companies because they are rich, extensive documents that can be used across labeling, regulatory, safety, and medical affairs. Food and Drug Administration (FDA) or European Medicines Agency (EMA). International sources: The focus for many labeling teams is on major sources such as FDA and EMA.