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Priority Medicines

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

FDA sets January decision date for Xalkori in ALK-positive lymphoma

FDA sets January decision date for Xalkori in ALK-positive lymphoma

Pfizer’s tyrosine kinase inhibitor (TKI) Xalkori has been granted a priority review by the US Food and Drug Administration (FDA) for the treatment of paediatric ALK-positive anaplastic large cell ... In addition to the FDA priority review, the European

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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, ... This means the out-of-pocket cost for healthcare has fallen,

  • The European Medicines Agency: PRIME’d for access? The European Medicines Agency: PRIME’d for access?

    The European Medicines Agency (EMA) is no different offering five routes that can hasten approval, under certain conditions. ... The most recently added – the PRIority Medicines (PRIME) scheme – reached its two-year anniversary in March 2018. .

  • Bluebird Bio: on the cusp of a gene therapy revolution Bluebird Bio: on the cusp of a gene therapy revolution

    The sickle cell programme has also been named on the FDA’s Regenerative Medicine Advanced Therapy designation (RMAT), a new fast-track specifically aimed at helping these cutting edge medicines gain ... PRIME (The PRIority Medicines scheme) provides

  • The real-world data conundrum The real-world data conundrum

    Regardless of what the actual total costs are, though, it is certain that, with very few exceptions, the era of blockbuster drugs is over and the demand for stratified medicines, affordable ... diseases. At a more fundamental level, though, availability

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

    In the first quarter of 2016, the EMA launched a scheme for PRIority MEdicines (PRIME), to optimise development plans and provide accelerated assessment for medicines that are of major interest for ... In 2016 special approval pathways and designations

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