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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. An observational study of safety and clinical outcome measures across patient groups in the United Kingdom Medical Cannabis Registry.

Medical 98
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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. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation.

Marketing 103
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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.