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Coronavirus Notebook: Moderna Vaccine First To Get GB Conditional MA, EMA To Update On AstraZeneca Blood Clot Issue

 
• By Ian Schofield

The EU has agreed to provide ‘solidarity vaccines’ to five member states and the WHO has published a progress report on its assessments of COVID-19 vaccines.

White flag with the Astrazeneca logo waving in the wind with the European flag in the background
The EMA is among agencies assessing the AZ vaccine safety issues • Source: Alamy

Moderna, Inc.’s RNA-1273 has become the first COVID-19 vaccine to receive a conditional marketing authorization (CMA) in Great Britain under a new mechanism introduced at the beginning of the year.

It has also just been launched in Wales, with the first doses to be administered from the West Wales General Hospital in Carmarthen starting on 7 April. Rollout will begin...

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More from Europe

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

More from Geography

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

Quotable: Top Experts On Policy Hot Topics

 
• By Anabel Costa-Ferreira

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.