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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

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.

Latest news

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
FDA gives breakthrough status to Xolair for food allergies

an FDA breakthrough designation for a new food allergy indication.
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

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

More than half of the projected blockbusters have been granted priority review, breakthrough therapy or fast-track designations by the US FDA. ... US FDA granted Hemlibra breakthrough therapy designation in April.

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Latest Intelligence

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

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

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

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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Approximately 0 fully matching, plus 4 partially matching documents found.

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