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Hansen Medical, Inc.

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Latest From Hansen Medical, Inc.

First Nasal Adrenaline Spray Among 10 Products Heading For EU-Wide Approval

The June meeting of the European Medicines Agency's human medicines committee brought mixed fortunes for companies. 10 new products were recommended for pan-EU approval, two drugs were rejected, while the conditional approval of one drug is set to be revoked. PTC Therapeutics again faced disappointment regarding its Duchenne muscular dystrophy drug Translarna, but has vowed to fight back.

Europe Drug Review

Alvotech Partners With Advanz On European Eylea Biosimilar

Alvotech has announced its latest European biosimilars partnership, collaborating with Advanz on both 2mg and 8mg aflibercept rivals to Eylea. The deal follows several other recent alliances as well as a raise in Alvotech’s full-year revenues guidance to as much as $500m.

Deals Biosimilars

Aurobindo One Step Closer To Xolair Biosimilar Registration

With originator Xolair’s patents already expired or about to end next year, Aurobindo’s CuraTeQ is on track with its omalizumab biosimilar for regulatory filings in 2024/2025, following a Phase I trial completion.

Biosimilars Clinical Trials

Celltrion Leads Xolair Biosimilar Race With US FDA Application

This marks Celltrion’s second regulatory submission for an omalizumab biosimilar as the US formulation patent protecting originator Xolair is set to expire late next year.

United States Biosimilars
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