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Latest From BioDelivery Sciences International, Inc.

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

US FDA Performance Tracker Approvals

Taiho’s Lytgobi Faces Heavy Competition, But Sets Efficacy Bar For Now

The FGFR inhibitor beats prior entrants on efficacy in cholangiocarcinoma, although Relay presented data at ESMO for its investigational RLY-4008 showing especially high efficacy and tolerability.

Approvals Business Strategies

Japan’s All-Genome Project Hopes To Push Pharma R&D

Japan is aiming for the betterment of pharma R&D and medical services for rare disease patients by building a database connecting genome analysis data and clinical records. While several clinical studies are planned for the next couple of years, there are also concerns around the actual trickle-down of benefits to patients and data privacy.

Japan Rare Diseases

SIFI’s Parasitic Eye Infection Drug & Biosimilar Aflibercept Among Raft Of EU Filings

Polyhexanide, from SIFI, could become the first approved treatment for acanthamoeba keratitis, while aflibercept could become the first biosimilar version of Eylea in the EU.

Europe Drug Review
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