Clinical study reports (CSRs) are comprehensive, standardized reports on clinical trials that pharmaceutical companies submit to authorities such as the European Medicines Agency (EMA) during drug approval procedures. In ...
Dec 2, 2021
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Stereotactic radiosurgery (SRS) for benign tumors of the vestibular nerve (vestibular schwannomas, also called acoustic neuromas) offers more advantages to affected patients than microsurgical resection: After targeted one-time ...
Oct 26, 2021
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The monoclonal antibodies nivolumab and ipilimumab have already undergone several early benefit assessments in various oncological indications. Since April 2021, the drug combination has also been approved for first-line ...
Oct 4, 2021
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Osimertinib was the first drug to be approved for adjuvant treatment after complete tumor resection in adults with stage IB to IIIA non-small cell lung cancer (NSCLC). In an early benefit assessment, the German Institute ...
Oct 1, 2021
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The monoclonal antibody lanadelumab has been approved in Europe since 2015 as a long-term prophylaxis to prevent attacks of hereditary angioedema. Since this is a rare disease, the Federal Joint Committee (G-BA) initially ...
Aug 20, 2021
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No benefit of high-flow therapy (HFT) can be derived from the available study data for patients with advanced chronic obstructive pulmonary disease (COPD) or chronic type 1 respiratory failure. It therefore remains unclear ...
Jul 20, 2021
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Since July 2020, remdesivir has been conditionally approved in Europe for the treatment of coronavirus disease (COVID-19) in adults and adolescents aged 12 years and older with pneumonia who require supplemental oxygen but ...
Jul 6, 2021
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In order to show the clinical relevance of a difference between two treatment alternatives, in recent years, the manufacturer dossiers submitted in early benefit assessments of new drugs have increasingly contained responder ...
Mar 4, 2021
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The combination of ibrutinib plus rituximab is approved for the treatment of adults with previously untreated chronic lymphocytic leukemia (CLL). In an early benefit assessment, the German Institute for Quality and Efficiency ...
Jan 5, 2021
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In a series of commissions awarded by the Federal Joint Committee (G-BA) to the Institute for Quality and Efficiency in Health Care (IQWiG), the question is whether for certain surgical procedures, a correlation can be shown ...
Dec 28, 2020
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