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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.

Immunomedics craters after FDA rejects breast cancer ADC

Immunomedics craters after FDA rejects breast cancer ADC

review of the drug for patients with advanced triple-negative breast cancer (TNBC) who have received at least two prior therapies for the disease. ... Sacituzumab govitecan – formerly known as IMMU-132 – is a Trop-2-targeting ADC that has

Latest news

  • First-line ovarian approval cements AZ’s Lynparza lead First-line ovarian approval cements AZ’s Lynparza lead

    Lynparza is already approved for this group but agreed to carry out this phase 3 study as a condition of accelerated review.

  • EMA to review Bluebird’s blood disorder gene therapy EMA to review Bluebird’s blood disorder gene therapy

    LentiGlobin could free patients of regular blood transfusions. 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

  • 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 company has now confirmed its intention to file LentiGlobin in TDT with

  • 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

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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,

  • Uncertainty, austerity and Brexit Uncertainty, austerity and Brexit

    Alongside this, rumours that NHS England was planning to include biosimilars on the Accelerated Access Pathway, the flagship policy intervention designed to speed up the use of innovative products, would amount ... Sciences Industrial Strategy and the

  • Working with our healthcare system more closely is vital Working with our healthcare system more closely is vital

    Specifically, this should include building on the recommendations put forward in the Life Science Industrial Strategy and the Accelerated Access Review, to streamline access evaluation processes for new therapies and enable

  • Macron, Merkel and May: implications of the 2017 elections for the life science industry Macron, Merkel and May: implications of the 2017 elections for the life science industry

    Furthermore, the 2017 Conservative Party election manifesto promised to ‘implement the findings of the Accelerated Access Review to make sure that patients get new drugs and treatments faster while the NHS

  • Europe vs the US: New drug product approvals Europe vs the US: New drug product approvals

    Expedited drug development and nonstandard review approval pathways are the new norm in the US, but in the EU special approval procedures are not as common. ... In 2016 special approval pathways and designations like Fast Track, Breakthrough, Accelerated

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