UK seeks own Breakthrough Therapy program
The UK is looking to create a Breakthrough Therapy regulatory pathway. Bloomberg reports that Under Secretary of State Frederick Curzon told an audience at the Empower Access to Medicines meeting that the government was “at an advanced stage” of establishing an expedited approval process similar to the FDA's.
The US set up the program in 2012, and has received 92 requests. Genentech's Gazyva, J&J/Pharmacyclics Imbruvica and Gilead's Sovaldi are among the breakthrough therapy designated drugs that have been approved.
Bloomberg notes that while the European Medicines Agency still governs what gets approved for the region, Britain's Medicines and Healthcare Products Regulatory Agency has say over how clinical trials are conducted and monitored in the UK.