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Off label use

This page shows the latest Off label use news and features for those working in and with pharma, biotech and healthcare.

Insmed claims first FDA okay for limited population antibiotic

Insmed claims first FDA okay for limited population antibiotic

We estimate that as many as 10, 000 to 15, 000 of NTM MAC patients in the US fail treatment, when using the off-label antibiotic regimen that is the current ... Despite the limited patient population, analysts have predicted that Arikayce could become a

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  • Healthcare systems

  • The gold standard of scientific evidence The gold standard of scientific evidence

    More than one in five prescriptions in the United States are for an off-label use; providing additional evidence to better understand treatment efficacy and safety is crucial. ... A path forward. Real-world evidence is already in use around the world.

  • Does safety sell medicines? Does safety sell medicines?

    New legislation in Europe introduced in 2012 has also led companies to expand what they collect from just side effects to reports of occupational exposure, off-label use and medication errors. ... Through the collection and review of adverse event

  • Pharma deals during February 2013 Pharma deals during February 2013

    Merck &Co has also returned to the biosimilar race following its exit from the Enbrel development programme after Amgen settled an off-label use case for Aranesp in December 2012. This ... Pharma will contribute 300 compounds and the remaining 200 will

  • Changes to pharmacovigilance legislation in Europe Changes to pharmacovigilance legislation in Europe

    of the marketing authorisation (off-label use), as well as the misuse and abuse of the medicinal product. . ... More generally, the competent authority may lay down 'any other conditions or restrictions with regard to the safe and effective use of the

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  • "Legal highs" ruling leaves illegal labs laughing

    This could explain the popularity of Bake Off and the reason so many Brits seem addicted to cake.  . ... There is a huge amount of off-label use of licensed medicines by medically qualified prescribers.

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