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adaptive licensing

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

Germany's IQWIG 'perplexed' by EMA's adaptive pathways plan

Germany's IQWIG 'perplexed' by EMA's adaptive pathways plan

A just-published report on the pilot acknowledges that further work needs to be done to develop an adaptive licensing pathway for new medicines, and notes specifically that the EMA wants ... to investigate ways to incorporate real-world evidence such as

Latest news

  • EMA says adaptive pathways programme still needs refinement EMA says adaptive pathways programme still needs refinement

    After its initial experience the EMA says adaptive licensing is "still a developing concept that will be refined as more medicines are considered", noting that even though the pilot has ended, ... To that end it has published new guidance for companies

  • EMA picks projects for adaptive licensing project EMA picks projects for adaptive licensing project

    Discussions have now started to see how the adaptive licensing approach can be implemented in practice. ... Earlier this year, UK Parliamentary Under Secretary of State for Quality Earl Howe told a workshop on adaptive licensing that if the approach is

  • EMA adaptive licensing project gathers pace EMA adaptive licensing project gathers pace

    The EMA has been talking about developing an adaptive licensing framework for some time and called for volunteer companies to take part in the pilot earlier this year. ... issues related to adaptive licensing, including the capacity of regulators to

  • Icon boost medical device trial capability with Aptiv acquisition

    Janssen and Lilly to form a consortium to work on adaptive dose finding trials.  . ... It's an area European regulators are planning to look at in more details soon, when they launch an adaptive licensing pilot.

  • EMA looks at flexible drug licensing EMA looks at flexible drug licensing

    Glybera was eventually approved for a narrower group of patients than originally sought but could have been made available sooner if an adaptive licensing framework was available, said the EMA. ... Meanwhile, other regulators around the world are also

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Latest Intelligence

  • Behavioural science in 2030 Behavioural science in 2030

    And I posit that this should be addressed through a further evolution of the novel adaptive licensing strategies currently being trialled in Alzheimer's disease and breast cancer.

  • Gathering pace: adaptive pathways Gathering pace: adaptive pathways

    issues related to adaptive licensing, including the capacity of regulators to tackle the extra workload. ... Meanwhile, other regulators around the world are also exploring the adaptive licensing model.

More from intelligence
Approximately 1 fully matching, plus 1 partially matching documents found.

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