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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.

To help unleash the power of AI, the UK government has decided it will not introduce legislation to govern these...

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EU Health Chief Declares There Is No Better Alternative Than TEVs to Spark Antibiotic Innovation

 
• By Francesca Bruce

Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.

EU Fines Alchem Over Buscopan API Cartel

 
• By Dave Wallace

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

European Industry Calls For Support As It Juggles Multiple Challenges

 
• By Dave Wallace

At Medicines for Europe’s legal and annual conferences in Brussels last week, multiple key issues competed for attention, giving the generics and biosimilars industry plenty to think about at a critical time for EU pharma reform.

More from Geography

EU Health Chief Declares There Is No Better Alternative Than TEVs to Spark Antibiotic Innovation

 
• By Francesca Bruce

Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.

EU Fines Alchem Over Buscopan API Cartel

 
• By Dave Wallace

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.