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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.

FDA awards another non-opioid pain drug breakthrough status

FDA awards another non-opioid pain drug breakthrough status

The US regulator yesterday awarded Concentric Analgesics and its pipeline drug CA-008 in post-surgical pain with an FDA Breakthrough Therapy designation (BTD). ... The Breakthrough Therapy designation is based on phase Ib placebo-controlled clinical

Latest news

  • FDA gives breakthrough status to Xolair for food allergies FDA gives breakthrough status to Xolair for food allergies

    FDA gives breakthrough status to Xolair for food allergies. Food allergies could open up big new market for biologic. ... Roche and Novartis’fast-maturing allergy drug Xolair has shown it’s still got plenty more to offer after picking up an FDA

  • Ionis and Roche gain PRIME status for Huntingdon’s disease candidate Ionis and Roche gain PRIME status for Huntingdon’s disease candidate

    PRIME stands for ‘Priority Medicines’and the fast-track system has been working for two years, and has similarities to the FDA’s Breakthrough Therapy designation. ... The news is welcome for Roche and Ionis, particularly as the FDA hasn’t yet

  • Bluebird’s first gene therapy gets European fast track Bluebird’s first gene therapy gets European fast track

    The therapy also has Breakthrough Therapy Designation status with the FDA, and US filing is expected to follow close behind Europe. ... Bluebird Bio: on the cusp of a gene therapy revolution (PME July/August Digital Edition).

  • The year of the blockbuster The year of the blockbuster

    More than half of the projected blockbusters have been granted priority review, breakthrough therapy or fast-track designations  by the US FDA. ... shown in that setting based  on which the US FDA granted Hemlibra breakthrough therapy designation in

  • Bluebird bags breakthrough status for CALD gene therapy Bluebird bags breakthrough status for CALD gene therapy

    Bluebird Bio has claimed an FDA breakthrough designation for its Lenti-D gene therapy for cerebral adrenoleukodystrophy (CALD) – a rare neurological disease mainly affecting young males. ... The breakthrough designation “brings us one step closer to

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Latest Intelligence

  • 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 ... 245. Athersys/ Healios.

  • 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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Latest from PMHub

  • 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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