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breakthrough status

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

UK firm Nightstar bags FDA fast-track status for gene therapy

UK firm Nightstar bags FDA fast-track status for gene therapy

UK firm Nightstar bags FDA fast-track status for gene therapy. Its choroideremia disease candidate gets RMAT designation. ... RMAT status is analogous to breakthrough status for drugs but applies to cell therapies and - since November 2017 - has been

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  • Significant figures Significant figures

    US regulators at the FDA have recognised the treatment’s potential, handing it breakthrough and fast-track status.

  • Deal Watch March 2017 Deal Watch March 2017

    Sacituzumab govitecan has been awarded breakthrough therapy status by the FDA.

  • Pharma deals during February 2014 Pharma deals during February 2014

    MK-3475 was awarded FDA breakthrough therapy status for advanced melanoma last year, and is being studied in 13 clinical trials across more than 30 types of cancer.

  • Orphan indication? No easy access Orphan indication? No easy access

    Developing drugs for rare diseases has its own set of unique challenges but, while the US continues to support orphan innovations through new policies like granting breakthrough status, European countries have ... This has recently been extended in the

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