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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.
Genfit claims FDA breakthrough status for liver disease drug
However, today’s breakthrough designation for elafibranor is in the Primary Billary Chloangitis (PBC) setting, a chronic autoimmune disease where bile ducts located in the liver are gradually destroyed, potentially leading ... The FDA’s decision to
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First-in-class hepatitis B/D drug raises cure hope
It has been given a breakthrough designation by the FDA, Priority Medicines (PRIME) status by the EMA and has been awarded a Promising Innovative Medicine (PIM) designation from the MHRA in
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J&J’s targeted bladder cancer treatment gets US approval
The drug, which will only be used in those whose disease has progressed during or following prior platinum-containing chemotherapy, received a breakthrough designation from the FDA in September last year, ... The results were deemed as a breakthrough, as
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Second chance for AstraZeneca’s selumetinib with breakthrough designation
uses. The partners have just announced that the FDA has granted the two companies Breakthrough Therapy Designation (BTD) for selumetinib in a rare paediatric condition. ... This designation is for the treatment of patients aged three years and older with
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AZ makes $6.9bn play for Daiichi Sankyo HER2 drug
The ADC has picked up a breakthrough designation from the FDA as treatment for advanced HER2-positive breast cancer who have previously been treated with Roche’s other HER2 drugs Herceptin
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Liver specialist Genfit files $120m IPO on Nasdaq
Elafibranor as already been granted a breakthrough designation from the US regulator in NASH, setting up a speedy review of the application if filed.
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Drug launches to watch in 2019
Analysts say the market could eventually be worth $4.8bn annually. The FDA granted AR101 Fast Track Designation for peanut allergy in September 2014 and Breakthrough Therapy Designation for peanut allergy ... Upadacitinib is already in a phase 3 trial in
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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
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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
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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
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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.
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Approximately 0 fully matching, plus 7 partially matching documents found.
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