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Latest From argenx N.V.

Gilead’s Long-Acting HIV Drug Among Latest EU Filings

The European Medicines Agency has added seven new products to its list of medicines that are under review for potential EU marketing authorization.

Europe Drug Review

Argenx's Ambitious Plans For Efgartigimod On Track

The company's first-in-class FcRn antagonist, which has an FDA action date in December, is now being reviewed by the EMA and although the regulator rejected a request for an accelerated assessment of efgartigimod for generalized myasthenia gravis, commercial teams are being built up in Europe.

Business Strategies Rare Diseases

Immunocore's Tebentafusp Sole Winner In EU Fast-Track Stakes In June

If Immuncore's tebentafusp is fast-tracked all the way through the centralized procedure at the EMA, it could be approved a few months earlier than it otherwise would be.

Europe Review Pathway

Alexion’s Phase III Data Position Ultomiris For Expansion Into Myasthenia Gravis

As its acquisition by AstraZeneca moves toward closure, Alexion plans to file the Soliris follow-on for generalized myasthenia gravis in the US, EU and Japan. But potential competition awaits in the C5 inhibitor and FcRn antagonist classes.

Clinical Trials Business Strategies
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