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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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  • EU’s 10-year paediatric meds report - not bad, but can do better EU’s 10-year paediatric meds report - not bad, but can do better

    label use of adult medicines in children, says the European Commission. ... These include “off-label use of products designed for adults, un-adapted rewards for innovation, and the lack of use of the Orphan Drugs Regulation for paediatric indications”

  • Are rare disease companies naturally more patient-centric? Are rare disease companies naturally more patient-centric?

    The starting point for this development pathway is usually off label use, where doctors have been confronted with a difficult patient with very little hope of a true diagnosis or suitable

  • Promoting off-label use: where to draw the line? Promoting off-label use: where to draw the line?

    to ensure the safe, effective and targeted off-label use', putting forward eight steps for decision-makers to follow. ... It seems inappropriate under EU law for public authorities to encourage the widespread off-label use of medicines.

  • Novartis' AMD drug pegpleranib fails phase III programme Novartis' AMD drug pegpleranib fails phase III programme

    s Eylea (aflibercept) and off-label use of Roche's Avastin (bevacizumab).

  • Up in smoke Up in smoke

    of off-label use of hundreds of molecules that have been supposedly 'studied extensively'. ... The very nature of off-label use suggests that there is a lack of evidence and the care with which clinicians use drugs off-label knowing that they haven't

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  • Healthcare systems

    Healthcare terms - 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. ... Between them they will use crowd sourcing to generate novel ideas on

  • 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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