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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.

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More from Europe

Leqembi Launch Set For Germany & Austria, EU-Wide Staggered Release Planned

 
• 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

 
• By Vibha Sharma

The European Medicines Agency has launched a phased initiative to consolidate the wide array of training materials for the Clinical Trials Information System, aiming to eliminate duplication, ensure consistency, improve accessibility and enhance user-friendliness.

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.

French Bill Could Improve Clinical Research, But Further Action Is Required

 
• By Francesca Bruce

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

More from Geography

FDA Special Assistant Høeg’s Vaccine Concerns On Display At ACIP

 
• By Sue Sutter

Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.

US FDA’s Advanced Manufacturing Designation Lifts Off With Cellares Cell Shuttle

 
• By Bridget Silverman

Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA

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.