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UK Early Access For BioCryst’s Hereditary Angioedema Drug

Berotralstat Could Overcome ‘Serious Limitations’ Of Existing Therapies

 
• By Ian Schofield

The HAE product, which meets the four criteria for pre-licensing use under the UK’s early access scheme, is currently undergoing regulatory evaluation in the EU, the US and Japan, with approval decisions expected in the last two countries next month.

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The UK EAMS unlocks access to unapproved drugs for unmet needs • Source: Shutterstock

BioCryst Pharmaceuticals, Inc.’s berotralstat has been given the go-ahead for pre-approval use in the UK for preventing recurrent attacks of the rare and potentially life-threatening disease, hereditary angioedema (HAE), under the Early Access to Medicines Scheme (EAMS).

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HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
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UK Promises To ‘Turbocharge’ Clinical Trials As US Tariff Threat Remains

 
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Trump’s Tariffs Will Lead To ‘Instability’ And ‘Less Investment’ In UK

 
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While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.

More from Europe

Leqembi Launch Set For Germany & Austria After Winning EU Approval At Last

 
• By Neena Brizmohun

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

EMA Initiative To Address Information Overload In CTIS Training Materials

 
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HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.