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BioMarin’s Roctavian & Argenx’s Efgartigimod Among Eight Hopefuls Awaiting EU Verdict

 
• By Vibha Sharma

Will BioMarin be second time lucky with its hemophilia gene therapy Roctavian in the EU? The European Medicines Agency could soon decide whether the product should be approved.

Red stamp and an imprint EMA (European Medicines Agency) on white surface. EMA is an agency of the EU in charge of the evaluation and supervision
Its decision time for drugs at the EMA’s CHMP meeting • Source: Alamy

The European Medicines Agency is this week due to decide whether to recommend pan-EU marketing approval for eight products, including BioMarin Pharmaceutical’s gene therapy, Roctavian (valoctocogene roxaparvovec), for severe hemophilia A, and argenx’s efgartigimod alfa for treating generalized myasthenia gravis.

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Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 
• By Eliza Slawther

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

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EU HTA Regulation: Don’t Forget About Vaccines, Industry Warns

 
• By Eliza Slawther

Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.

More from Geography

ICH Modernizes Stability Testing Guideline

 
• By Vibha Sharma

The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.

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• By Bridget Silverman

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