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regulatory decisions

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

Eli Lilly and Incyte's Olumiant approved by FDA for hospitalised COVID-19 patients

Eli Lilly and Incyte's Olumiant approved by FDA for hospitalised COVID-19 patients

Lilly has submitted applications for regulatory approval or authorisation to multiple regulatory agencies around the world and anticipates further regulatory decisions to follow.

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  • 20 for 2020 – Five pharma companies to watch 20 for 2020 – Five pharma companies to watch

    The deal was announced in June 2019 and took months to go through the antitrust regulatory process, but according to AbbVie – which agreed a massive $30bn bond issue to help finance ... BMS has warned its drug will be under pressure next year, but says

  • Assessing the risks in annuity pricing models Assessing the risks in annuity pricing models

    Several clinical programmes have advanced to late-stage development with regulatory decisions pending or on the horizon. ... Research also included a global review of launch dates and regulatory information related to several cell and gene therapies.

  • The evolution of real-world studies The evolution of real-world studies

    regulatory decisions for drugs including Pfizer’s Ibrance. ... The EMA expanded on its approach to RWE through a document detailing how it sees regulatory science evolving through to 2025.

  • The real-world data conundrum The real-world data conundrum

    Similarly, regulators are now increasingly growing to appreciate that real-world data, typically collected for non-regulatory purposes in electronic medical records, registries and administrative and claims databases, may provide new ... Indicatively, in

  • Is your multichannel having the desired impact on both your customer and business? Is your multichannel having the desired impact on both your customer and business?

    The life sciences have some unique characteristics in how 'purchasing' decisions are made, the regulatory environment and the fact there are limited post 'sale' touch points to build the experience over

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