Convincing payers to fund a $3m therapy is no mean feat, even for innovations with curative potential. Orchard Therapeutics, a company with much experience in this field, tells the Pink Sheet why it values open dialogues, and outlines how health technology assessment methods could be improved.

Companies making blood-based cancer screening tests face a number of barriers to full market entry but getting a foothold of any kind can be the start of a path towards greater ultimate uptake.

Shared REMS, diverse confirmatory trials and manufacturing delays are among the highlights in the latest US FDA drug approval news from the Pink Sheet’s US FDA Performance Tracker.

CSL Behring said it remains confident that a market access agreement for its hemophilia B gene therapy Hemgenix can be reached after England’s HTA body NICE rejected the product because of uncertainties over its long-term benefit and cost-effectiveness.