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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.

Pfizer’s Prevnar-13 successor takes aim at Merck rival

Pfizer’s Prevnar-13 successor takes aim at Merck rival

the US market after getting a breakthrough designation (BTD) for its candidate.

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  • Bluebird Bio: on the cusp of a gene therapy revolution Bluebird Bio: on the cusp of a gene therapy revolution

    Bluebird’s four breakthrough candidates. In addition to the two LentiGlobin-based treatments, the company also has its Lenti-D product for patients with cerebral adrenoleukodystrophy (CALD), a rare, serious and ... There is no question that these

  • 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.

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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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