Posts by Sophie Höhn

IRDiRC label attached to projects in ...

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Challenging patents to diagnose Long ...

December 22, 2014 In Canada, the Children’s Hospital of Eastern Ontario is challenging gene patents held by companies in the Federal Court of Canada. The hospital is specifically challenging the patent held on a genetic test for long QT syndrome – a rare genetic disorder with fatal consequences. Testing for the gene in people with […]

Linked2Safety project: secure medical...

December 17, 2014 The Linked2Safety project, funded under the FP7 scheme of the European Commission, was launched to advance clinical practice and accelerate medical research by providing pharmaceutical companies, healthcare professionals and patients with an “innovative semantic interoperability framework, facilitating efficient and homogenised access to distributed Electronic Health Records (EHRs)”. Electronic Health Records (EHRs) contain an […]

Japan’s regulatory agency shoul...

December 15, 2014 An article published in the Annals of Oncology discusses clinical trial endpoints acceptable to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to approve oncology drugs. The authors highlight that acceptance of surrogate endpoints is essential to accelerate drug approval. However, following guideline revisions in Japan, the number of accepted surrogate endpoints […]

State of the Art review of regulatory...

    December 12, 2014 A review published in Clinical Pharmacology & Therapeutics outlines regulatory activities geared towards accelerated access and reimbursement benefits for patients in need across four regulatory agencies. The authors drew up two tables providing comprehensive information on the existing, emerging and new regulatory access and reimbursement policies implemented in the United States, Europe, Singapore […]

Publication of the Health Technology ...

Publication of the Health Technology Assessment EU strategy paper

December 11, 2014 The Health Technology Assessment (HTA) strategy paper, supported by the Joint Action EUnetHTA, provides evidence-based information and analysis to help decision-makers achieve sustainable healthcare systems and promote innovative healthcare options for patients. The paper highlights cooperation as the cornerstone for better healthcare assessment and reimbursement in Europe. It also unveils a strategy […]