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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

German health technology assessment body IQWiG has said it is concerned by the reliance on real-world evidence in the EMA's plans for adaptive licensing of new drugs. ... A just-published report on the pilot acknowledges that further work needs to be

Latest news

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

    EMA says adaptive pathways programme still needs refinement. Scheme aims to accelerate patient access to new drugs. ... After its initial experience the EMA says adaptive licensing is "still a developing concept that will be refined as more medicines are

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

    EMA picks projects for adaptive licensing project. Begins discussions on how the model will be implemented in practice. ... Discussions have now started to see how the adaptive licensing approach can be implemented in practice.

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

    EMA adaptive licensing project gathers pace. Regulator picks two drugs to pilot early access scheme. ... issues related to adaptive licensing, including the capacity of regulators to tackle the extra workload.

  • Icon boost medical device trial capability with Aptiv acquisition

    Aptiv Solutions' adaptive trial capabilities will further differentiate and enhance our services to help our customers identify the most promising drug candidates earlier. ... It's an area European regulators are planning to look at in more details soon,

  • 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.

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Latest from PMHub

  • The heart of the matter - Part Three

    Regulatory developments are also a driver for RWE. For instance, the EMA’ s adaptive licensing pilot is exploring whether it’ s possible to draw inferences from observational studies and whether these ... Adaptive licensing approaches may, for example

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