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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.
BMS/bluebird bio resubmit FDA application for myeloma CAR-T
J&J picked up a breakthrough therapy designation (BTD) from the FDA last year for its candidate, JNJ-4528, after the therapy demonstrated impressive results in a phase 1b/2 study
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Pfizer eyes 20-strain Prevnar filing this year, after phase 3 win
breakthrough designation from the FDA for use in children.
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J&J’s bispecific lung cancer antibody nabs FDA breakthrough status
Potential treatment for patient group with no FDA-approved drugs. Johnson and Johnson has been awarded a breakthrough designation from the FDA for a bispecific antibody for lung cancer that combines ... Last year, Spectrum Pharmaceuticals reported some
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Trevena gets second go at FDA approval for pain drug
Rubbing further salt into the wounds, the FDA then withdrew its breakthrough designation for oliceridine last year, saying that the phase 3 data for Trevena’s drug weren’t strong enough
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BMS unveils long-term results for Opdivo in kidney cancer
respectively. Initial results from the CheckMate-025 study formed the basis of an FDA breakthrough designation for Opdivo in this setting, and the subsequent approval for the checkpoint inhibitor in advanced
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Clovis leapfrogs PARP rivals, filing Rubraca for prostate cancer
All three of the PARP inhibitors have been awarded a breakthrough designation from the FDA in prostate cancer, reflecting the urgent need for new therapies to treat the disease.
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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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COVID-19 Updates and Daily News
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