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regulatory submission

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

AZ to seek approval for "long-acting" COVID-19 antibodies

AZ to seek approval for

AstraZeneca will prepare regulatory submission of the prophylaxis data from both PROVENT and STORM CHASER for health authorities for potential emergency use authorisation or conditional approval.

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  • Medicinal data – what’s next for IDMP? Medicinal data – what’s next for IDMP?

    The first step has been to define electronic data submission for the centralised regulatory process only, via EMA’s Gateway and/or application programming interface (API). ... processes – the basis of all future regulatory information-based activity,

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

    Finally, a data readout for roxadustat is expected by the end of 2018, and regulatory submission in the first half of 2019.

  • AI’s potential in the pharma life cycle AI’s potential in the pharma life cycle

    Increasing regulatory submission success. On a more traditional, operational basis, AI offers a path through the data complexity that has typically held back life science organisations from becoming more agile, innovative ... up. An AI system that is

  • Deal Watch November 2016 Deal Watch November 2016

    In May this year Sandoz announced that a regulatory submission for its version of rituximab had been accepted by the EMA following multiple clinical trials in over 800 patients. ... Eagle's current focus is on the development of novel, optimised

  • Creative marketing and compliance Creative marketing and compliance

    Automate as much as possible As approving agencies update their submission processes and go digital, the ability to automate the process becomes possible, even essential. ... With all the checks and balances in place from the implementation of DAM and

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