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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.

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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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. . ... There are currently no FDA-approved drugs
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 ... The BTD process will see

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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
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
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

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