Has Competition Reassurance Helped Counter Combination Woes In The UK?

The rate of non-submissions for combination therapies in England has been on a downward trend in the last two years.

CMA logo
Competition concerns over combination products may be easing (Shutterstock)

Efforts to ease competition concerns could be having a positive impact on pharmaceutical companies’ willingness to make submissions for combination therapies to England’s health technology assessment (HTA) institute, NICE, according to a Pink Sheet analysis of NICE data.

More from Health Technology Assessment

More from Pathways & Standards

US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations

 

FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.

EMA Considers Whether Intrathecal Zolgensma Deserves Fast Tracking

 

Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.

Surrogate Endpoint ‘Reasonably Likely’ Decision Process An ‘Uncertain Standard,’ Industry Says

 
• By 

The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.