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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.

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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Provention Bio wins PRIME designation for type 1 diabetes prevention drug

We are very pleased the EMA recognises the transformative potential of PRV-031 and has granted this groundbreaking therapy PRIME designation", said Ashleigh Palmer, CEO of Provention Bio. ... Following on the heels of Breakthrough Therapy Designation
J&J bags FDA breakthrough designation for prostate cancer drug

Could challenge rival PARP inhibitor Lynparza. The FDA has granted Johnson &Johnson's PARP inhibitor niraparib a breakthrough therapy designation (BTD) in prostate cancer, helping it to make gains on rival ... We are pleased with the FDA’s Breakthrough
Bluebird Bio reveals further encouraging data for CALD gene therapy

Study shows continued benefit in treatment of rare disease. Last year, Bluebird Bio claimed an FDA breakthrough designation for its Lenti-D gene therapy for cerebral adrenoleukodystrophy (CALD) – it has now ... Lenti-D is Bluebird’s lead gene
Roche wins FDA breakthrough for Gazyva in lupus nephritis

Drug originally approved as a lymphoma treatment. Roche has been granted a breakthrough therapy designation (BTD) from the FDA in the US for its lymphoma medicine Gazyva(obinutuzumab) in lupus nephritis. . ... The Swiss pharma company has been aiming
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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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

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