Please login to the form below

Not currently logged in
Email:
Password:

breakthrough designation

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

Lilly and Banner Alzheimer’s Institute collaborate on donanemab prevention trial

Lilly and Banner Alzheimer’s Institute collaborate on donanemab prevention trial

In June, the US Food and Drug Administration (FDA) Lilly’s donanemab a breakthrough therapy designation (BTD) based on results from the phase 2 TRAILBLAZER-ALZ study.

Latest news

More from news
Approximately 1 fully matching, plus 162 partially matching documents found.

Latest Intelligence

  • AI: the smart money is on the smart thinking AI: the smart money is on the smart thinking

    efficiently. The CTEPH Pattern Recognition Artificial Intelligence obtained FDA Breakthrough Device Designation in December 2018.

  • Orphan drugs and breakthrough therapies drive Cortellis Drugs to Watch 2019 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 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 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 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

More from intelligence
Approximately 0 fully matching, plus 9 partially matching documents found.

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
An agency called Owen

We’re a Healthcare Communications Agency specialising in Multi-channel Marketing to make you Digitally Fitter, Stronger & Faster....

Latest intelligence

Robust Review: COVID19 Assessment
See how our client utilized Rapid Payer Response (RPR) to stay informed and gain continuous insights during the recent global pandemic (COVID19)...
Human behaviour - Sept 21
All change – how untangling human behaviour can encourage better health
Driving better patient outcomes through clear, achievable practical steps that are underpinned by transparent evidence...
Health literacy in the time of COVID-19
In a time when much of the media’s focus is on the ongoing COVID-19 pandemic and the differences in vaccination rates between various regions, countries, and socioeconomic groups, improving health...