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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.

the US market after getting a breakthrough designation (BTD) for its candidate.

J&J files ‘breakthrough’ bladder cancer drug in US

J&J files ‘ breakthrough’ bladder cancer drug in US. Needed as most patients don't respond to checkpoint inhibitors. ... Erdafitinib (JNJ-42756493) picked up a breakthrough designation (BTD) from the FDA earlier this year, so should benefit from a
New data keeps AbbVie’s star pipeline therapies on track

Upadacitinib is already in a phase III trial in atopic dermatitis and picked up a breakthrough designation (BTD) from the FDA for this indication earlier this year.
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 rejects GSK’s Nucala for COPD

Another potentially strong challenge could come from AZ and Amgen’s tezepelumab, which has just been awarded a breakthrough designation from the FDA for severe asthma.
FDA rejects GSK’s Nucala for COPD

Another potentially strong challenge could come from AZ and Amgen’s tezepelumab, which has just been awarded a breakthrough designation from the FDA for severe asthma.

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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

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
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.
Pharma deals during October 2014

Imbruvica was one of the first products to gain approval via the breakthrough designation pathway and has European approval for use in mantle cell leukaemia and chronic lymphocytic leukaemia.

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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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