The European Union’s authorization of CTI BioPharma Corp.’ Pixuvri (pixantrone) for the treatment of non-Hodgkin B-cell lymphomas is perhaps paving the way towards a greater acceptance of the conditional and, potentially in the future, staggered approval entry systems.
Pixuvri’s Conditional EU Approval Could Herald The Rise Of Staggered Approval
CTI’s conditional EU approval for its non-Hodgkin B-cell lymphoma drug Pixuvri goes against the run of the drug in the US, but reinforces the idea that staggered approvals are on the way in Europe.
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While the pharma industry appears to be exempt from US tariffs imposed by President Trump, a member of the UK House of Lords says the details are unknown and warned that uncertainty “leads to less investment” in business as a whole.
The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
The UK government has listened to industry concerns about high clawback rates under the voluntary scheme and will review it in June in a bid to resolve the issue and “move on to bigger and more important things,” health secretary Wes Streeting says.