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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.

Boehringer bags FDA OK for Ofev in rare lung disease ILD

Boehringer bags FDA OK for Ofev in rare lung disease ILD

Now it has been approved after a priority review by the US regulator, reflecting the lack of therapies available for SSc-ILD.

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

    One Japanese Sakigake designation. One Chinese Priority Review. Interestingly, this year’s list contains no cancer drugs. ... Upadacitinib was filed for approval in the US and EU in December 2018 and accepted for US Priority Review in February 2019.

  • 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

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