Please login to the form below

Not currently logged in
Email:
Password:

accelerated review

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

EMA to review Bluebird’s blood disorder gene therapy

EMA to review Bluebird’s blood disorder gene therapy

Bluebird Bio announced late last week that the European Medicines Agency has accepted its gene therapy LentiGlobin for accelerated review. ... The accelerated review status means the EMA could reach a decision in as little as five months for the one-time

Latest news

  • Bluebird’s first gene therapy gets European fast track Bluebird’s first gene therapy gets European fast track

    Gene therapy company Bluebird Bio is on course to file its first product later this year, and has just been granted an accelerated review by the European Medicines Agency. ... The agency’s accelerated assessments can cut the active review time of a

  • The year of the blockbuster The year of the blockbuster

    The FDA accepted the filing for elagolix with a priority review and a decision is expected mid-year. ... Regulatory filings were submitted in the US and EU in Q1 with priority review and accelerated assessment granted in the US and EU, respectively.

  • EMA starts rapid review of Shire’s HAE antibody EMA starts rapid review of Shire’s HAE antibody

    Shire could be months away from its first regulatory approval for hereditary angioedema (HAE) candidate lanadelumab as the EMA starts an accelerated review of the drug. ... The EMA accelerated review means a verdict is due in 150 days rather than the

  • Ex-GSK head Witty to head group overseeing UK fast-track scheme Ex-GSK head Witty to head group overseeing UK fast-track scheme

    be selected for the Government’s new Accelerated Access Pathway (AAP), due to come into effect next April. ... Last October, the independent Accelerated Access Review (AAR) led by Sir High Taylor set out a series of recommendations for streamlining the

  • NICE: We're the institute of 'yes' NICE: We're the institute of 'yes'

    The Strategy also made a series of recommendations that would overlap with and supplement the Accelerated Access Review, including parallel processing of MHRA and NICE assessments, a single appraisal process and ... The event also heard industry praise

More from news
Approximately 1 fully matching, plus 53 partially matching documents found.

Latest Intelligence

  • China: AstraZeneca’s new engine for growth and innovation China: AstraZeneca’s new engine for growth and innovation

    In March 2017, AZ’s targeted lung cancer drug Tagrisso was one of the first medicines to gain approval through the Chinese Food and Drug Administration (CFDA) ’s Priority Review pathway, ... Roxadustat is under accelerated review and, if approved,

  • Lighting the way Lighting the way

    Lighting the way. How the UK’ s Accelerated Access Review aims to guide medical innovations to their destination. ... She noted that engaging with the government on the new Life Sciences Strategy (see p7) and the Accelerated Access Review were among

More from intelligence
Approximately 0 fully matching, plus 2 partially matching documents found.

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
M3 (EU)

M3 was founded in 2000 with the goal of changing the world of medicine through making full use of the...

Latest intelligence

EU
Innovation in merger control and the impact on the pharmaceutical sector
Is focusing on pipeline products enough to assess regulatory risks?...
Nudge-nudge, think-think
Chris Ross examines the personal complexities of human behaviour – and explains why fun, emotion and peer endorsement could be key to designing effective behavioural change programmes...
Peoples Award
Quality in Care Diabetes 2018: the best in innovative diabetes care
Awards highlight new evidence-based approaches to improving care...

Infographics