Search Results for G-BA

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Germany Reimbursement Profile By Elvira Müller, PhD, MPH - Published 03 October 2017

This profile summarizes the reimbursement process in Germany, presents responsibilities for key stakeholders and highlights issues for consideration early in the development process.

Categories: Features, Europe, Drugs, Medical Devices, Reimbursement, Submission and registration

Tags: G-BA, IQWiG, GKV-SV, InEK

Following Negative Comments by Reviewer, EU Committee OK's Gene Therapy By Michael Mezher - Published 06 May 2015

Last month, German regulators postponed their review of UniQure's gene therapy Glybera after the European Medicines Agency (EMA) rapporteur assigned to the product claimed new data showed Glybera lacked efficacy and called for it to be reassessed.

Categories: Clinical, Postmarket surveillance, Regulatory strategy, Submission and registration

Tags: Committee for Advanced Therapies, CAT, G-BA, Federal Joint Committee, Glybera, UniQure, Gene therapy

German Regulators Decry Lack of Trial Transparency in Look at Stem Cell Transplantation By Michael Mezher - Published 01 May 2015

The German Institute for Quality and Efficiency in Health Care (IQWiG) has found recent clinical data on the use of stem cell transplantation to treat multiple myeloma—a rare and deadly form of cancer—to be inconclusive.

Categories: News, Europe, Blood, Clinical, Drugs, Human cell and tissue

Tags: IQWiG, Stem cell transplantation, multiple myeloma, Federal Joint Committee, G-BA

First EU-Authorized Gene Therapy Hits Snag, Benefit Assessment Delayed in Germany as EMA Reviews New Report By Michael Mezher - Published 17 April 2015

Regulators at the German Federal Joint Commission (G-BA) have postponed their review of the gene therapy Glybera, Reuters reports. The decision was made after the European Medicines Agency (EMA) rapporteur assigned to Glybera found the product lacked efficacy and called for it to be reassessed.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Orphan products, Postmarket surveillance, Submission and registration

Tags: Glybera, Gene therapy, Committee on Advanced Therapies, CAT, Federal Joint Commission, G-BA

German Price Watchdog Says ‘No’ to 3 Cancer Drugs By Michael Mezher - Published 23 January 2015

The Institute of Quality and Efficiency in Healthcare (IQWiG) gave negative assessments for three recently approved cancer drugs this month.

Categories: News, Europe, Clinical, Prescription drugs, Reimbursement

Tags: IQWiG, Health Technology Assessment, HTA, G-BA, Federal Joint Committee, AMNOG