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accelerated review

This page shows the latest accelerated review news and features for those working in and with pharma, biotech and healthcare.

Provention Bio wins PRIME designation for type 1 diabetes prevention drug

Provention Bio wins PRIME designation for type 1 diabetes prevention drug

data. A PRIME designation gives medicines priority and provides them with special support – this includes enhanced interaction and dialogue, and an accelerated evaluation and review.

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  • China: AstraZeneca’s new engine for growth and innovation China: AstraZeneca’s new engine for growth and innovation

    In March 2017, AZ’s targeted lung cancer drug Tagrisso was one of the first medicines to gain approval through the Chinese Food and Drug Administration (CFDA)’s Priority Review pathway, ... Roxadustat is under accelerated review and, if approved,

  • Uncertainty, austerity and Brexit Uncertainty, austerity and Brexit

    Alongside this, rumours that NHS England was planning to include biosimilars on the Accelerated Access Pathway, the flagship policy intervention designed to speed up the use of innovative products, would amount ... Sciences Industrial Strategy and the

  • Working with our healthcare system more closely is vital Working with our healthcare system more closely is vital

    Specifically, this should include building on the recommendations put forward in the Life Science Industrial Strategy and the Accelerated Access Review, to streamline access evaluation processes for new therapies and enable

  • Macron, Merkel and May: implications of the 2017 elections for the life science industry Macron, Merkel and May: implications of the 2017 elections for the life science industry

    Furthermore, the 2017 Conservative Party election manifesto promised to ‘implement the findings of the Accelerated Access Review to make sure that patients get new drugs and treatments faster while the NHS

  • Europe vs the US: New drug product approvals Europe vs the US: New drug product approvals

    Expedited drug development and nonstandard review approval pathways are the new norm in the US, but in the EU special approval procedures are not as common. ... In 2016 special approval pathways and designations like Fast Track, Breakthrough, Accelerated

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