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priority review

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

The year of the blockbuster

The year of the blockbuster

More than half of the projected blockbusters have been granted priority review, breakthrough therapy or fast-track designations  by the US FDA. ... The FDA accepted the filing for elagolix with a priority review and a decision is expected mid-year.

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  • Pharma deals continue to slide Pharma deals continue to slide

    Gilead has been trying to diversify away from anti-viral therapies into oncology and Kite is a good fit with its CAR-T technology and a lead product in priority review ... Headline. $m. Kite (US). Gilead (US). Company acquisition. CAR-T technology with

  • 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

  • Deal Watch February 2017 Deal Watch February 2017

    Large pharma out-licensing. In our Annual Review of deals for 2016 we noted that AstraZeneca was the most active large pharma in divesting non-core assets. ... Sale of Priority Review Voucher (PRV). 125. Cytokinetics/ Royalty Pharma. 4.5% royalty on

  • Lighting the way Lighting the way

    Lighting the way. How the UK’ s Accelerated Access Review aims to guide medical innovations to their destination. ... Dr Stewart told the seminar there was a clear case of need for the Review. “

  • Market access improvements in Turkey Market access improvements in Turkey

    It classifies marketing authorisation applications as 'normal', 'priority' or 'high priority' with target assessment times of 210 days, 180 days and 150 days respectively (excluding any clock stops). ... While welcoming the promise of a slight

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  • The Heart of the Matter 7: Reality Dawns

    As patient-centricity becomes embedded as a key priority for payers and providers, greater emphasis is being placed on real-world data and how it can be used to measure clinical ... Similarly, we also leveraged real-world historical comparator data to

  • A forward march for adaptive designs

    This echoes strong positive signals this year from regulatory agencies, which included potential priority review status for IND applications whose clinical studies employ adaptive design. ... Companies submitting an IND application can now potentially

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Random42 is the world's leading medical animation company. Over the past 25 years we have produced core digital assets for...

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