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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.

BMS/bluebird bio resubmit FDA application for myeloma CAR-T

BMS/bluebird bio resubmit FDA application for myeloma CAR-T

J&J picked up a breakthrough therapy designation (BTD) from the FDA last year for its candidate, JNJ-4528, after the therapy demonstrated impressive results in a phase 1b/2 study

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  • AI: the smart money is on the smart thinking AI: the smart money is on the smart thinking

    efficiently. The CTEPH Pattern Recognition Artificial Intelligence obtained FDA Breakthrough Device Designation in December 2018.

  • Orphan drugs and breakthrough therapies drive Cortellis Drugs to Watch 2019 Orphan drugs and breakthrough therapies drive Cortellis Drugs to Watch 2019

    Nine US, four EU and one Japanese Orphan Drug designation. Four US Breakthrough Therapy designations. ... This determination may mean that instead of expedited review because of AR-101’s Breakthrough Therapy designation, the filing may be given a

  • 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

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