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priority review

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

More good news, and some bad, for Merck’s Keytruda

More good news, and some bad, for Merck’s Keytruda

The positive news for Merck was that the FDA has started its priority review of Keytruda (pembrolizumab) in its first small cell lung cancer (SCLC) indication, as the company tries to ... It’s the second priority review filing for Keytruda to get

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  • AstraZeneca: building a new ‘open innovation’ pharma company AstraZeneca: building a new ‘open innovation’ pharma company

    Lastly, AZ has also gained three Breakthrough Therapy Designations (including two Orphan Drug Designations) and six additional Priority Review Designations.

  • 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, ... This means the out-of-pocket cost for healthcare has fallen,

  • Pharma deals continue to slide Pharma deals continue to slide

    Gilead has been trying to diversify away from anti-viral therapies into oncology and Kite is a good fit with its CAR-T technology and a lead product in priority review ... Headline. $m. Kite (US). Gilead (US). Company acquisition. CAR-T technology with

  • 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

  • Deal Watch February 2017 Deal Watch February 2017

    Large pharma out-licensing. In our Annual Review of deals for 2016 we noted that AstraZeneca was the most active large pharma in divesting non-core assets. ... Sale of Priority Review Voucher (PRV). 125. Cytokinetics/ Royalty Pharma. 4.5% royalty on

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  • A forward march for adaptive designs

    This echoes strong positive signals this year from regulatory agencies, which included potential priority review status for IND applications whose clinical studies employ adaptive design. ... Companies submitting an IND application can now potentially

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