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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.

Novartis’ lung cancer drug wins FDA Breakthrough Therapy Designation

Provides hope for new treatment of rare cancer. Novartis’ investigational therapy capmatinib for patients with MET-mutated advanced non-small cell lung cancer (NSCLC) has received Breakthrough Therapy Designation (BTD) from ... to bring capmatinib to

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Finch Therapeutics bags $53m for microbiome therapies

Earlier this year, Finch gained a breakthrough therapy designation (BTD) from the FDA for CP101. ... Finch will also use the financing to accelerate the development of a therapy for Autism Spectrum Disorder (ASD).
Regeneron scores positive data in phase 3 cholesterol trial

These results follow the FDA in the US granting evinacumab Breakthrough Therapy designation in 2017, for the treatment of hypercholesterolemia in patients with HoFH.
Imbruvica gains expanded use in Europe

prior therapy. ... As of August 2019, it is looking even more likely to catch up to Imbruvica, with the FDA in the US granting Calquence Breakthrough Therapy Designation as a monotherapy treatment for
Vertex files cystic fibrosis triple therapy with FDA

If approved, the triple therapy could transform treatment of the disease – and Vertex’s fortunes with it. ... The three-in-one pill looks odds-on to gain FDA approval, having been granted a breakthrough therapy designation in 2018, and is likely to
Genfit claims FDA breakthrough status for liver disease drug

However, today’s breakthrough designation for elafibranor is in the Primary Billary Chloangitis (PBC) setting, a chronic autoimmune disease where bile ducts located in the liver are gradually destroyed, potentially leading ... The FDA’s decision to

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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
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
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
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
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