Please login to the form below

breakthrough designation

This page shows the latest breakthrough designation news and features for those working in and with pharma, biotech and healthcare.

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

Latest news

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. .
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
Finch Therapeutics bags $53m for microbiome therapies

Earlier this year, Finch gained a breakthrough therapy designation (BTD) from the FDA for CP101.
BeiGene gets speedy US review for lymphoma drug zanubrutinib

claimed a breakthrough designation earlier this year.
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.

More from news
Approximately 1 fully matching, plus 131 partially matching documents found.

Latest Intelligence

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

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
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

More from intelligence
Approximately 0 fully matching, plus 8 partially matching documents found.

Featured jobs

Account Manager – Healthcare advertising: Salary TBC

Strategic Planner, Healthcare Advertising Agency: Salary TBC

Account Director – UK Office: Excellent salary and benefits

Events Executive: DOE

Account Manager, Healthcare Communications: £32, 000 - £40, 000 bonus benefits

Senior Medical Writer: Competitive salary plus benefits

Client Services Director- Flexible Working: Negotiable

Subscribe to our email news alerts

PMHub

Add my company

Aptus Health

Aptus Health is dedicated to advancing health engagement. The company offers end-to-end digital health engagement solutions spanning all areas of...

Latest intelligence

Report: Customer experience, shaping digital healthcare: In this issue of ‘Perspective’ we speak with industry experts to learn about the world of digital healthcare, and how pharma is beginning to utilise these modern technologies to enhance...
Encouraging signs in biomarker R&D: The cancer immunotherapy firms ramping-up biomarker R&D...
Programmatic methodology and why you should be using it: What is it? How does it work? Why is everyone talking about it? By Richard Webb - Associate Director...