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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.
Merck KGaA gains exclusive rights to Debiopharma’s late-stage oncology asset
The drug was granted a US Food and Drug Administration (FDA) breakthrough therapy designation for previously untreated locally advanced head and neck cancer, alongside current standard of care, in February 2020
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AZ, Amgen’s tezepelumab reduces asthma exacerbations in broad patient population
In September 2018, tezepelumab scored a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) in patients with severe asthma without an eosinophilic phenotype.
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Roche’s tiragolumab plus Tecentriq combo wins FDA breakthrough therapy designation
Swiss pharma is aiming for approval in first-line NSCLC. Swiss pharma company Roche has scored a breakthrough therapy designation (BTD) from the US Food and Drug Administration for its combination
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Novartis receives FDA breakthrough therapy designation for rare disease med
Swiss pharma company Novartis has received a breakthrough therapy designation (BTD) for its experimental medication iptacopan for the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH). ... The European Medicines Agency (EMA) has also granted
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Biogen signs $3.1bn deal with Sage for potential depression therapies
Zuranolone already has a breakthrough therapy designation from the US FDA. ... Zuranolone is currently being studied in phase 3 development and has already picked up a breakthrough therapy designation from the US Food and Drug Administration (FDA) for MDD
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AZ, Amgen’s investigational asthma drug comes good in phase 3
In September 2018, tezepelumab scored a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) in patients with severe asthma without an eosinophilic phenotype.
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AI: the smart money is on the smart thinking
efficiently. The CTEPH Pattern Recognition Artificial Intelligence obtained FDA Breakthrough Device Designation in December 2018.
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Orphan drugs and breakthrough therapies drive Cortellis Drugs to Watch 2019
Nine US, four EU and one Japanese Orphan Drug designation. Four US Breakthrough Therapy designations. ... This determination may mean that instead of expedited review because of AR-101’s Breakthrough Therapy designation, the filing may be given a
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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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TRIDUCIVE
Triducive are a strategic healthcare consultancy who produce communications that have practical, dynamic application that encourage behaviour change because of the...
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