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Coronavirus Notebook: EMA Issues New COVID-19 Vaccine Safety Updates, Australia Assesses Comirnaty In Younger Children

 
• By Ian Schofield

The European regulator has warned of the risk of myocarditis, pericarditis and anaphylaxis with Novavax’s COVID-19 vaccine, Nuvaxovid, while Switzerland has updated its guidance on the use of COVID-19 medicines against virus variants. Iconovo has received funding to develop its ICOone nasal inhaler for use in pandemics in resource-poor settings.

Coronavirus disease pandemic Europe economics impact 3D concept. European economy background: covid-19 ncov 2019 corona virus, European Union flag
The EU is keeping a close eye on COVID 19 vaccine side effects • Source: Shutterstock

The European Medicines Agency’s pharmacovigilance committee, the PRAC, has issued a series of safety updates and recommendations for changes to the product information for a number of COVID-19 vaccines.

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India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
• By Anju Ghangurde

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

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• By Sue Sutter

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

 
• By Bridget Silverman

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