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Apellis Pharmaceuticals, Inc.

http://www.apellis.com/

Latest From Apellis Pharmaceuticals, Inc.

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.

Clinical Trials Drug Approval Standards

Sobi To Go Private In $8.1bn Buyout That Appreciates Growth Strategy

Agnafit Bidco, comprised of Advent International and an affiliate of GIC Pte Ltd, will pay a premium for the rare disease specialist in an effort to capture value from Sobi’s planned growth.  

Deals Business Strategies

US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development

Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.

Approvals Review Pathway
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