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accelerated review

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

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

Latest news

  • 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

  • Gilead gets OK for three-in-one hep C therapy in US Gilead gets OK for three-in-one hep C therapy in US

    Gilead has also filed for the sofosbuvir, velpatasvir and voxilaprevir therapy in the EU, winning an accelerated review from the EMA in January.

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Latest Intelligence

  • 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

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