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Breakthrough Therapy Designation

This page shows the latest Breakthrough Therapy Designation news and features for those working in and with pharma, biotech and healthcare.

EMA to review Bluebird’s blood disorder gene therapy

EMA to review Bluebird’s blood disorder gene therapy

Meanwhile, the FDA has granted an orphan drug status and a breakthrough therapy designation for LentiGlobin for the treatment of TDT. ... although this won't produce the potentially curative results seen with Bluebird's gene therapy.

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

    There is no question that these products are truly groundbreaking: three have FDA Breakthrough Therapy Designation and two have the similar PRIME designation from the EMA. ... The sickle cell programme has also been named on the FDA’s Regenerative

  • 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 ... therapy treatments

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

    What selumetinib does is potentially deliver a new targeted therapy into an area where there aren't any targeted therapies,” says Galbraith. ... This drug has recently received Breakthrough Therapy designation from the US FDA and phase 1 data will be

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