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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.

Genfit claims FDA breakthrough status for liver disease drug

Genfit claims FDA breakthrough status for liver disease drug

However, today’s breakthrough designation for elafibranor is in the Primary Billary Chloangitis (PBC) setting, a chronic autoimmune disease where bile ducts located in the liver are gradually destroyed, potentially leading ... The FDA’s decision to

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  • Drug launches to watch in 2019 Drug launches to watch in 2019

    Analysts say the market could eventually be worth $4.8bn annually. The FDA granted AR101 Fast Track Designation for peanut allergy in September 2014 and Breakthrough Therapy Designation for peanut allergy ... Upadacitinib is already in a phase 3 trial in

  • 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.

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