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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.
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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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 ... in multiple myeloma patients who had received at least three prior
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J&J and Bristol-Myers Squibb/Bluebird bio reveal rival CAR-T data
J&J’s CAR-T candidate – JNJ-4528 – impressed at the conference, as well as at the FDA, so much so that the drug has been granted a breakthrough therapy designation ... BMS/Bluebird also had their own CAR-T data in hand, from the phase 2 KarMMa
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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
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