As the first drug approved in nearly 20 years for primary biliary cholangitis, Ocaliva has been priced aggressively at $69,350 a year, but Intercept Pharmaceuticals Inc. CEO Mark Pruzanski believes the drug's safety and efficacy as well at its need in second-line therapy will prove out over time.
Intercept's Pricing Of Ocaliva Anticipates Outcomes Data
With OCA approved for primary biliary cholangitis, Intercept anticipates a potentially slow ramp of sales, but has priced product at $69,350 a year based on need in second-line treatment and in anticipation of survival benefit data.
More from United States
• By
Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
• By
Experts say PBMs should become familiar with transparency rules and prepare to release data, although more legal wrangling could occur.
• By
Optum Rx, one of the largest PBMs in the US, declared it was the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.
• By
FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.
More from North America
• By
In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
• By
A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.
• By
The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.