UK Pips EU To The Post With ‘Project Orbis’ Approval For Tagrisso

EU Early-Use Approval For AstraZeneca’s NSCLC Drug Imminent

The UK drug regulator, the MHRA, has approved its first product under Project Orbis, the US-led international regulatory collaboration scheme it joined four months ago to speed up access to promising cancer medicines.

Double Exposure Team Teamwork Togetherness Collaboration Concept
Regulatory collaboration is expected to help speed up drug approvals • Source: Alamy

Tagrisso (osimertinib), AstraZeneca’s lung cancer treatment, has become the first product to be approved by the UK medicines regulator under Project Orbis, the US-led scheme that enables international regulators to simultaneously review new cancer drugs and approve them faster.

More from United Kingdom

AI Could Be Used ‘In The Deliberation’ Of HTA Reviews In England, Says NICE

 

England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.

England’s NICE Wants Industry Involvement In HTA Sandbox Projects

 

Pharmaceutical companies are being encouraged to reach out to NICE in relation to its HTA Innovation Lab, which provides a sandbox environment in which the health technology assessment body can test new methods of evaluating “innovative and disruptive” therapies.

England’s NICE To ‘Explore’ Severity Modifier Changes As Cost-Effectiveness Threshold Branded ‘Ridiculous’

 

Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.

Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 

Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.

More from Europe