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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.

Roche undercuts price of Bayer cancer drug after winning FDA approval

Roche is working with Foundation Medicine to prepare a filing for FDA approval of the companion diagnostic, but for now no dedicated test is available. ... Vitrakvi also came to market without a companion diagnostic. Rozlytrek and Vitrakvi are part of a

Latest news

Lynparza cleared as ovarian cancer maintenance therapy on Cancer Drugs Fund

Around 22% of ovarian cancer patients carry a BRCA mutation, which must be identified via a companion diagnostic test.
FDA clears Novartis’ new breast cancer drug Piqray

A companion diagnostic developed by Qiagen to test for the mutation has also been approved by the FDA.
Liver specialist Genfit files $120m IPO on Nasdaq

Funds will go towards NASH candidate, a companion diagnostic and a liver disease drug. ... diagnostic for NASH to identify patients suitable for treatment with its drug, with another $6m set aside for testing the drug in combination regimens.
Loxo, Bayer get FDA okay for biomarker-driven cancer drug

At the moment there is no companion diagnostic for NTRK fusions so patients need to be identified through genomic profiling techniques such as immunohistochemistry or genetic sequencing approaches, which tend to ... To try to address the diagnostic issue,
Loxo, Bayer get quick FDA review for ‘precision’ cancer drug

To try to address that issue, Loxo formed a partnership earlier this year with Illumina to develop a companion diagnostic – called TruSight Tumour 170 – that will use sequencing to identify whether

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Latest Intelligence

Encouraging signs in biomarker R&D

The response has been a surge of interest in developing novel companion biomarkers, and biomarkers that allow personalisation of therapy. ... The confounding issue is that, in the case of PD-1/PD-L1 drugs, each developer uses its own companion diagnostic
Drug launches to watch in 2019

At the moment there is no companion diagnostic for NTRK fusions so patients need to be identified through genomic profiling techniques such as immunohistochemistry or genetic sequencing approaches, which tend to
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.

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Latest from PMHub

Mastering the precision medicine opportunity

Novartis and Roche are two champions of personalised medicine, shaping the area with the launch of targeted treatments combined with a companion diagnostic to support patient identification. ... approval of their new FoundationOne CDx, the first and

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