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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.

Heron boosted by new data for ‘breakthrough’ pain drug

Heron Pharma has new data on its combination anaesthetic drug, and a breakthrough designation from the FDA, which suggests it could have an impact on the post-operative pain market. ... The new breakthrough designation adds to an earlier fast-track

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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
Sage surges after depression drug gets rapid path to approval

December, and already has breakthrough designation from the FDA.
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
More encouraging data for Spark and Pfizer’s potential haemophilia B cure

Nevertheless, the data builds on earlier readouts suggesting the partners have a major clinical breakthrough on their hands: just one out of 15 patients experienced a bleed four weeks after treatment – ... complete. SPK-9001 has been granted FDA
Pfizer drug gets speedy FDA review for rare heart failure complication

Pfizer has been awarded a breakthrough designation from the FDA for tafamidis as a treatment for the rare disease transthyretin cardiomyopathy – suggesting its marathon effort to get the drug to the

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Latest Intelligence

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.
Interview: AstraZeneca's Susan Galbraith

This drug has recently received Breakthrough Therapy designation from the US FDA and phase 1 data will be presented at ASCO in June.

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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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