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What Does The UK’s ‘Flexible’ Approach To AI Regulation Mean For Pharma?

 
• By Eliza Slawther

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.

Artificial intelligence
• Source: Shutterstock

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.

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EMA To Consider Approvals For Eight Orphans, Including Vertex’s CF Drug Alyftrek

 
• By Francesca Bruce

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Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 
• By Eliza Slawther

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

EU Biosimilar Filings, Opinions And Approvals

 
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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

Industry Highlights Issues With EU HTA Regulation’s PICO Framework For Vaccines

 
• By Eliza Slawther

Vaccine developers should be aware that the framework underpinning the new EU Health Technology Assessment (HTA) Regulation might not be suitable for immunizations, but actions from policymakers and industry could help mitigate some issues, a senior figure from GSK says.

More from Geography

EMA To Consider Approvals For Eight Orphans, Including Vertex’s CF Drug Alyftrek

 
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The European Medicines Agency is this week expected issue opinions on whether the European Commission should grant EU marketing authorization for 19 new products.

Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 
• By Neena Brizmohun

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

Proposed HHS Budget Would Eliminate Medicare Negotiation Program Start-Up Funding

 
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The preliminary budget document supports legislation clawing back funds appropriated for the program.