Regulatory and health technology assessment advice on post‐licensing and post‐launch evidence generation is a foundation for lifecycle data collection for medicines

11 March 2020 - The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially ...

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HTA for pharmaceuticals in Europe: will the mountain deliver a mouse?

10 March 2020 - For at least two decades, health technology assessment has been considered worldwide the most comprehensive and suitable ...

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Registry-data – of sufficient quality – are suitable for the extended benefit assessment of drugs

24 January 2020 - Rapid report shows how routine practice data should be collected and processed. ...

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Asfotase alfa in hypophosphatasia in children and adolescents: survival advantage for small children

15 January 2020 - Weak evidence does not allow a specific statement to be made about the extent of the added ...

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Larotrectinib in tumours with NTRK gene fusion: data are not yet sufficient for derivation of an added benefit

15 January 2020 - First assessment of a histology-independent drug/studies without control arms. ...

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Differences in health technology assessment recommendations among European jurisdictions: the role of practice variations

14 January 2020 - HTA recommendations vary widely throughout Europe, even for the same medicine. ...

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Commission proposal for a European regulation on HTA

29 November 2019 - Europe cannot afford an inefficient system for joint clinical assessments. ...

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Pembrolizumab in metastatic NSCLC: now added benefit for subpopulations

19 September 2019 - After a methodological uncertainty has been resolved, analyses on overall survival are now usable ...

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5 people setting EU drug prices

19 September 2019 - Politic’s guide to the policy makers debating how to calculate the cost of cures. ...

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Germany may have the answer for reducing drug prices

11 September 2019 - American lawmakers attempting to stem spiraling drug costs might find inspiration in Germany, where the government’s ...

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Dacomitinib in advanced lung cancer: variety of disadvantages lifts survival advantage

 1 August 2019 - Prolonged survival is sometimes accompanied by severe side effects, symptom and quality of life deterioration ...

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Ezetimibe reduces the risk of heart attacks and strokes

26 July 2019 - Added to existing statin therapy, ezetimibe is preventative in patients with CHD and acute coronary syndrome. ...

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Evaluation of ethical analyses in seven reports from the European Network for Health Technology Assessment

16 July 2019 - Ethics has been considered among the core domains of health technology assessment, but there are still ...

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Early benefit assessment reveals weaknesses in the development of new drugs

11 July 2019 - Analysis of 216 AMNOG assessments in the BMJ / Proposals for more targeted drug development ...

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New drugs: where did we go wrong and what can we do better?

10 July 2019 - More than half of new drugs entering the German health care system have not been shown to ...

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