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Coronavirus Notebook: UK To Start World’s First COVID-19 Challenge Study, Janssen Files Its Vaccine For EU Approval

 
• By Ian Schofield

Cuba is about to begin Phase III trials with one of its four homegrown coronavirus vaccines, Australia has provisionally approved the AstraZeneca/Oxford University product, and the EU has upped its orders from Pfizer/BioNTech and Moderna.

Hand in surgery glove holding syringe with covid vaccine. Cuban flag in the background
Cuba is pursuing its own vaccine development program • Source: Shutterstock

The UK’s clinical trials ethics body has given the go-ahead to the world’s first COVID-19 human challenge study in an effort to better understand how the virus works in the body and help to develop new vaccines and treatments for the disease.

The initial virus characterization study is expected to begin within the next few weeks. It will recruit up to 90...

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More from Europe

Spain’s Medicines Shortages Plan Clears Administrative Hurdles For Essential Medicine Manufacturers

 
• By Francesca Bruce

A new plan to tackle medicine shortages proposes to develop a set of incentives for companies to manufacture essential medicines in Spain.

EU Industry Proposes 3-Basket Strategy To Phase Out Animal Testing

 
• By Eliza Slawther

A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.

England Leads Europe In Reimbursing Vertex’s Next-In-Class CF Drug Alyftrek

 
• By Neena Brizmohun

Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.

UK HRA Working On ‘Trusted’ Path Forward To Support Simplified Informed Consent

 
• By Vibha Sharma

The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.

More from Geography

Animal Testing Alternatives: US Pharmacopeia On Its Testing Transition

 
• By Eliza Slawther

In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.

EU Industry Proposes 3-Basket Strategy To Phase Out Animal Testing

 
• By Eliza Slawther

A “basket approach” to phasing out animal testing could help identify areas where “moonshot” research is required to implement new approach methodologies, according to EU industry federation EFPIA.

England Leads Europe In Reimbursing Vertex’s Next-In-Class CF Drug Alyftrek

 
• By Neena Brizmohun

Vertex said it reached “a broad reimbursement agreement” with the National Health Service for its once-daily, triple combination treatment for cystic fibrosis. As for reimbursement in the rest of Europe, the company is targeting Ireland, Denmark and Germany next.