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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.

Ionis and Roche gain PRIME status for Huntingdon’s disease candidate

Ionis and Roche gain PRIME status for Huntingdon’s disease candidate

More good news for Ionis after first drug approval. Ionis and Roche’s pipeline drug for Huntingdon’s disease has been granted special ‘PRIME’status by the European Medicines Agency (EMA). ... PRIME stands for ‘Priority Medicines’and the

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  • 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

  • Market access improvements in Turkey Market access improvements in Turkey

    Almost the entire pharmaceutical market is made up of prescription medicines (93.8%) with 87% reimbursed. ... While welcoming the promise of a slight acceleration of review time with high priority medicines, industry is disappointed that orphan drugs and

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