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breakthrough designation

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

Heron boosted by new data for ‘breakthrough’ pain drug

Heron boosted by new data for ‘breakthrough’ pain drug

Heron Pharma has new data on its combination anaesthetic drug, and a breakthrough designation from the FDA, which suggests it could have an impact on the post-operative pain market. ... The new breakthrough designation adds to an earlier fast-track

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  • Deal Watch February 2017 Deal Watch February 2017

    IMMU-132 has FDA Breakthrough Therapy designation for the treatment of patients with TNBC who have failed prior therapies for metastatic disease and also has Fast Track status and orphan designation

  • Deal Watch January 2016 Deal Watch January 2016

    32, 000. Seres Therapeutics/ Nestle Health Science. Collaboration. Rights to market products including SER 262 (p1 for Clostridium difficile), 287, 301 and 109 (SER 109 has breakthrough therapy designation); includes $120m

  • Creating a 21st century life sciences ecosystem Creating a 21st century life sciences ecosystem

    Part of the scheme involves a new 'promising innovative medicine' designation - similar to the FDA's breakthrough designation - the first of which have started to be awarded.

  • Pharma deals during October 2014 Pharma deals during October 2014

    Imbruvica was one of the first products to gain approval via the breakthrough designation pathway and has European approval for use in mantle cell leukaemia and chronic lymphocytic leukaemia.

  • Interview: AstraZeneca's Susan Galbraith Interview: AstraZeneca's Susan Galbraith

    This drug has recently received Breakthrough Therapy designation from the US FDA and phase 1 data will be presented at ASCO in June.

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  • The Heart of the Matter 7: Reality Dawns

    At Amgen, our CfOR infrastructure has helped us use RWE to achieve orphan drug designation. ... Similarly, we also leveraged real-world historical comparator data to mazimise a first-to-market opportunity with a breakthrough therapy designation, priority

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