Developing an early stage biopharmaceutical asset in Europe: Navigating treacherous waters

A blog post about how manufacturers can create an “Early Asset Success Plan” for new products

When biopharmaceutical products launch in the European Union, even experienced manufacturers can struggle to overcome the demanding standards of European payers. The complex market authorisation requirements and subsequent access decisions across 28 countries can lead to challenging timelines and confusing rollouts. Unfortunately for manufacturers, the future of European commercial planning…

Strategic Patient Advocacy vs. Evidence Package: The “Rare” Challenge for Orphan Drug Manufacturers

UPDATE – December 2017: After initially refusing to reimburse EXONDYS 51™, ANTHEM and EMBLEMHEALTH reversed their decisions in late 2017. While EMBLEM opted for a somewhat restrictive policy requiring patients to complete at least 300m in the 6-MWT, ANTHEM decided to cover patients as long as they are ambulatory. In their…

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