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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.
Lilly and Banner Alzheimer’s Institute collaborate on donanemab prevention trial
In June, the US Food and Drug Administration (FDA) Lilly’s donanemab a breakthrough therapy designation (BTD) based on results from the phase 2 TRAILBLAZER-ALZ study.
Latest news
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FDA grants priority review for AZ, Amgen’s tezepelumab for asthma
In September 2018, tezepelumab received a breakthrough therapy designation (BTD) from the FDA in patients with severe asthma without an eosinophilic phenotype.
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Breakthrough therapy designated for Lilly’s investigational Alzheimer’s drug donanemab
The US Food and Drug Administration (FDA) has granted Eli Lilly’s investigational Alzheimer’s disease drug donanemab a breakthrough therapy designation (BTD).
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GSK partners with iTeos Therapeutics on next-gen immuno-oncology drug
A number of additional pharma companies are also seeking to bring an anti-TIGIT candidate to market – including Roche, which recently scored a breakthrough therapy designation (BTD) for its TIGIT blocker
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Novartis’ iptacopan scores positive results in rare blood disorder PNH
Last December, the US Food and Drug Administration (FDA) granted iptacopan a breakthrough therapy designation for the treatment of PNH and a rare paediatric disease designation for C3G. ... The European Medicines Agency (EMA) has also granted iptacopan a
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AZ, Amgen file first-in-class asthma drug with the FDA
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.
FDA grants priority review for AZ, Amgen’s tezepelumab for asthma
Breakthrough therapy designated for Lilly’s investigational Alzheimer’s drug donanemab
GSK partners with iTeos Therapeutics on next-gen immuno-oncology drug
Novartis’ iptacopan scores positive results in rare blood disorder PNH
AZ, Amgen file first-in-class asthma drug with the FDA
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Approximately 1 fully matching, plus 162 partially matching documents found.
Latest Intelligence
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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
AI: the smart money is on the smart thinking
Orphan drugs and breakthrough therapies drive Cortellis Drugs to Watch 2019
Drug launches to watch in 2019
Bluebird Bio: on the cusp of a gene therapy revolution
Deal Watch February 2017
More from intelligence
Approximately 0 fully matching, plus 9 partially matching documents found.
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