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Apellis Pharmaceuticals, Inc.

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Latest From Apellis Pharmaceuticals, Inc.

Gilead’s First-In-Class Drug For Aggressive Breast Cancer On Track For EU Approval

EU reviewers have recommended five new medicines and a pneumococcal vaccine for EU-wide approval. New uses of several approved medicines have also drawn the thumbs up, while the sponsor of a cancer drug has withdrawn its product from the review process.

Approvals Drug Review

Gilead Awaits EMA Verdict On Trodelvy As It Whizzes Through EU Review

Sponsors of six new products, including a first-in-class treatment for unresectable locally advanced or metastatic triple-negative breast cancer, will find out this week if their products are on course to be approved for use in the EU. Also, two sponsors might be asked to address last-minute questions about their drugs.

Approvals Drug Review

BeiGene’s Brukinsa Among Five Orphan Drugs Awaiting EU Approval Verdict

Sponsors of several new medicines are set to learn if their products are on track for pan-EU approval. One product on the list is Pfizer/Lilly’s osteoarthritis drug, tanezumab, which recently ran into trouble in the US.

Drug Review Approvals

Apellis Says Mixed Phase III Results Position Geographic Atrophy Candidate For Filing

Apellis plans to file pegcetacoplan for approval as the first drug to treat the advanced AMD condition geographic atrophy, despite the C3 inhibitor hitting its endpoint in only one of two pivotal trials.

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