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Coronavirus Notebook: EU Filing For Russian Vaccine, UK Links With CureVac Against Virus Variants

 
• By Ian Schofield

There is some good news from UK and EU vaccine safety reviews, the WHO reports on COVAX vaccine distribution to less well off countries, and the European Commission and Pfizer agree on the supply of 300 million more vaccine doses.

ampoules with Covid-19 vaccine on a laboratory bench. to fight the coronavirus / sars-cov-2 pandemic
Vaccine development continues amid threats from new virus variants • Source: Shutterstock

Russia’s Sputnik V coronavirus vaccine has been filed for registration in the EU, according to the organization funding development of the vaccine, the Russian Direct Investment Fund (RDIF).

On 9 February, the RDIF issued a statement saying that the EU registration filing had been made on 29 January and that it had "started submitting the information to EMA [European Medicines Agency] for the rolling review

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EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

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New EU Filings

 
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Managed Access Agreement Fails To Help BioMarin’s Brineura Secure Routine Reimbursement In England

 
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Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

More from Geography

EU Shaping Biotech Act To Unleash SME Potential

 
• By Neena Brizmohun

European companies, in particular small and midsize enterprises, spin-offs and start-ups have a hard time expanding within the single market “because of a complex regulatory framework that is perceived as slow and burdensome,” according to the European Commission.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.