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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.

BioMarin eyes 2019 FDA filing for haemophilia A gene therapy

BioMarin eyes 2019 FDA filing for haemophilia A gene therapy

We are meeting with the FDA regularly, consistent with [valrox’] status as a breakthrough therapy, and our most recent interactions with the FDA have given us increased confidence and alignment on

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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

    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. Financial terms for these deals were

  • 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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Porterhouse Medical Group

The Porterhouse Medical Group provides market research, insights, and scientific and medical communication services to the pharmaceutical industry across the...

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