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FDA Breakthrough Therapy Designation
This page shows the latest FDA Breakthrough Therapy 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
As part of the collaboration, Lilly and Banner will introduce a more virtual approach to the evaluation of the potential Alzheimer’s therapy. ... In June, the US Food and Drug Administration (FDA) Lilly’s donanemab a breakthrough therapy designation
Latest news
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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
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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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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
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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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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 ... According to Roche, tiragolumab is the first
FDA grants priority review for AZ, Amgen’s tezepelumab for asthma
Novartis’ iptacopan scores positive results in rare blood disorder PNH
FDA removes clinical hold on uniQure’s haemophilia gene therapy
Merck KGaA gains exclusive rights to Debiopharma’s late-stage oncology asset
Roche’s tiragolumab plus Tecentriq combo wins FDA breakthrough therapy designation
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Approximately 1 fully matching, plus 49 partially matching documents found.
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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 ... Licence. 145. Sarepta Therapeutics/ Gilead
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Interview: AstraZeneca's Susan Galbraith
What selumetinib does is potentially deliver a new targeted therapy into an area where there aren't any targeted therapies,” says Galbraith. ... This drug has recently received Breakthrough Therapy designation from the US FDA and phase 1 data will be
Bluebird Bio: on the cusp of a gene therapy revolution
Deal Watch February 2017
Interview: AstraZeneca's Susan Galbraith
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Approximately 0 fully matching, plus 3 partially matching documents found.
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