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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.

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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.

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Odd Coupling: J&J, RallyBio Collaborate As Only Firms Focused On FNAIT

While not co-developing each other’s drugs, J&J and financially troubled RallyBio are working on complementary approaches to the rare disease fetal and neonatal alloimmune thrombocytopenia.

Rare Diseases Business Strategies

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.

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