Artificial intelligence (AI) has the potential to unlock “once unimaginable life saving treatments for cruel diseases like cancer and dementia,” according to the UK’s secretary of state for science, innovation and technology, Michelle Donelan.
What Does The UK’s ‘Flexible’ Approach To AI Regulation Mean For Pharma?
The UK government says that its non-legislative approach to AI regulation will promote innovation and allow it to react quickly to changes in the ecosystem. But a life sciences lawyer warns that creating an uncertain regulatory environment could be problematic.
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In a historic move for Africa, five products have been backed for approval via a pilot that tested a continental listing process.
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Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.
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The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
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Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.
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One CDRH employee said the cuts already are having a major effect on morale.
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Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
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Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.