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Latest From Incyte Corporation

Keeping Track: Takeda’s Exkivity Clears US FDA; BeiGene’s Busy Summer

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals

Part D Cost Sharing Cap May Have Broadest Benefit For Jakafi, Revlimid, Pomalyst, Imbruvica Users

A cap set at $2,000 would help nearly 1 million more seniors than a cap set at $3,100, according to new study by Kaiser Family Foundation. Either competing legislative proposal would probably be welcomed by pharma industry as way to defuse pricing debate.

Medicare Legislation

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
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