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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.

$5.76bn deal puts Merck closer to Eisai and fast-growing Lenvima

$5.76bn deal puts Merck closer to Eisai and fast-growing Lenvima

He added there was “strong scientific evidence”behind the combination, pointing out that the duo has been awarded breakthrough status by the FDA for RCC.

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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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Rainmaker Healthcare Communications

Rainmaker is an independent, award-winning communications agency with offices in London and Atlanta. Our experience across pharmaceuticals, generics, OTC, medical...

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