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Coronavirus Notebook: EMA Starts Review Of HIPRA’s COVID-19 Vaccine, Moderna To Set Up Australian mRNA Plant

 
• By Ian Schofield

There is no shortage of news relating to potential new COVID-19 treatments and vaccines. Among other things, zapnometinib, an antiviral compound being developed by German firm Atriva, has shown strong efficacy against Omicron in a Phase I study. Also, Sweden’s ISR and Iconovo have expanded their collaboration deal to accelerate the development of an inhaled COVID-19 vaccine.

Vaccine COVID-19 virus SARS-COV-2 OMICRON strain coronavirus with vaccine concept background
A new COVID-19 vaccine is under review in Europe • Source: Alamy

A candidate COVID-19 vaccine developed by the Spanish company, HIPRA, has begun a rolling review at the European Medicines Agency for use as a booster in adults who have already been fully vaccinated with another vaccine. According to the company, the vaccine could be approved by the beginning of June.

This brings to five the number of vaccines under rolling review at the agency.

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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.