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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.

FDA green lights BMS’ multiple myeloma combo

FDA green lights BMS’ multiple myeloma combo

FDA green lights BMS’ multiple myeloma combo. Speedy approval follows a breakthrough designation. ... Now, after a breakthrough designation, BMS has gained approval of Empliciti as part of a new combination known as EPd.

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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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M3 (EU)

M3 was founded in 2000 with the goal of changing the world of medicine through making full use of the...

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World Diabetes Day: Interaction and impact of diabetes on mental health
For World Diabetes Day on the 14th November 2018, Nisha Shahrukh - Medical Writer at Mednet Group has written an article depicting the impact diabetes has on mental health. Including...
EU
Innovation in merger control and the impact on the pharmaceutical sector
Is focusing on pipeline products enough to assess regulatory risks?...
Nudge-nudge, think-think
Chris Ross examines the personal complexities of human behaviour – and explains why fun, emotion and peer endorsement could be key to designing effective behavioural change programmes...

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