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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.

Life sciences and NHS feature in Johnson speech – but Brexit promises predominate

Life sciences and NHS feature in Johnson speech – but Brexit promises predominate

The sector is once again preparing itself for the special measures needed in the even of a no-deal exit, in which imports of medicines would be given number one priority.

Latest news

  • First-in-class hepatitis B/D drug raises cure hope First-in-class hepatitis B/D drug raises cure hope

    It has been given a breakthrough designation by the FDA, Priority Medicines (PRIME) status by the EMA and has been awarded a Promising Innovative Medicine (PIM) designation from the MHRA in

  • Janssen’s CAR-T gains PRIME status in Europe Janssen’s CAR-T gains PRIME status in Europe

    EMA fast-track could help Janssen close gap. Janssen has been granted a valuable PRIME (Priority Medicines) designation from the European Medicines Agency for its CAR-T candidate for multiple myeloma,

  • Medicines will take priority over food in no-deal Brexit Medicines will take priority over food in no-deal Brexit

    The UK is more reliant on the EU for medicines than food, says Hancock. ... However, he said the UK was much more reliant on medicines from the EU27 than food, with around half of all drugs imported via the EU, so it makes sense to

  • EMA sees approval numbers rise in 2018 EMA sees approval numbers rise in 2018

    The EMA has made similar moves in recent years with its own ‘accelerated assessment’ routes for priority innovations, such as the Priority Medicines scheme (PRIME), which hits its third year in ... Lastly, the EMA’s key human medicines committee,

  • Roche gains EU PRIME status for Spinraza rival Roche gains EU PRIME status for Spinraza rival

    Oral treatment joins Novartis' gene therapy challenger. Roche has been granted PRIME (PRIority MEdicines) designation in the EU for risdiplam, its small-molecule drug for spinal muscular atrophy that could be

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Latest Intelligence

  • 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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