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companion diagnostic

This page shows the latest companion diagnostic news and features for those working in and with pharma, biotech and healthcare.

EMA starts firming up its stance on personalised medicines

New draft European guidelines on personalised medicines and companion diagnostics are expected to be released by December 2018. ... As diagnostic medical devices, companion diagnostics do not fall within the oversight of the EMA, but the regulator is set

Latest news

Celgene, Agios get FDA OK for leukaemia drug Idhifa

A companion diagnostic from Abbott Labs that detects mutations in the IDH2 gene in blood or bone marrow samples has been approved alongside the new drug.
AZ takes Chi-Med’s kidney cancer drug into phase III

He noted that the company has developed a companion diagnostic that will be used to select patients for its phase III programme.
AZ gets first OK for PD-L1 inhibitor durvalumab

The FDA also approved Roche's Ventana PD-L1 assay as a companion diagnostic for assessing PD-L1 protein levels in biopsy tissue.
Novartis' Rydapt approval ends long AML therapy drought

The US agency cleared Novartis' Rydapt (midostaurin) for use alongside chemotherapy in newly-diagnosed AML patients who carry the FLT3 mutation, also giving the okay for a FLT3 companion diagnostic developed
Celgene bags US priority review for cancer metabolism drug

It has also filed for approval of a companion IDH2 diagnostic.

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Latest Intelligence

Harnessing complexity

This delicate balance between companion diagnostics' clinical utility and their potential confounding impact on patient treatment is a growing dilemma. ... Answering this question in full requires a scientific journey to better understand what a
Diagnostics are rising up the pharma value chain

Diagnostic drivers. It's not just this idea of changing public attitudes that is creating renewed interest in the diagnostics sector; the sector is also influenced by the wider forces affecting ... GlaxoSmithKline and Boehringer Ingelheim have had
Deal Watch table for June 2014

50. NanoString Technologies/ Celgene. Development. Development of a companion diagnostic assay.
Pharma deals during June 2014

a deal with NanoString Technologies for the development of a companion diagnostic assay to support the development of Revlimid for treatment of Diffuse Large B-Cell Lymphoma at a more modest
Interview: John Dineen, GE Healthcare

some of these markers can be converted into a companion diagnostic product after the completion of a late-stage clinical trial. ... We can then ensure our diagnostic is closely coupled with the therapeutic capability.

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