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Breakthrough Therapy Designation
This page shows the latest Breakthrough Therapy Designation news and features for those working in and with pharma, biotech and healthcare.
FDA grants priority review for AZ, Amgen’s tezepelumab for asthma
The US Food and Drug Administration (FDA) has accepted AstraZeneca (AZ) and Amgen’s submission for their investigational asthma drug tezepelumab and granted a priority review for the therapy. . ... In September 2018, tezepelumab received a
Latest news
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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.
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FDA removes clinical hold on uniQure’s haemophilia gene therapy
The US Food and Drug Administration (FDA) has removed a clinical hold on Dutch biotech uniQure’s haemophilia B gene therapy, following concerns over a case of cancer in a patient ... AMT-061 has been granted breakthrough therapy designation by the FDA
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
FDA removes clinical hold on uniQure’s haemophilia gene therapy
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Approximately 5 fully matching, plus 74 partially matching documents found.
Latest Intelligence
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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
There is no question that these products are truly groundbreaking: three have FDA Breakthrough Therapy Designation and two have the similar PRIME designation from the EMA. ... The sickle cell programme has also been named on the FDA’s Regenerative
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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 ... therapy treatments
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 6 partially matching documents found.
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