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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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We are one of the largest independent healthcare market research and consulting agencies in the world. Trusted partner to the...

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Developing advocacy in the pharmaceutical industry.
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GDPR and events. What does the pharma industry need to know?
Many people in the pharma industry still aren’t following the rules set out by the GDPR when it comes to running events and attending tradeshows. But with eye-watering fines for...
Digital trends in B2B sales - how far behind is Pharma?
The modern approach to B2B sales is data-driven, and enabled by digital tools....

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