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FDA puts breakthrough tag on Roche, Lilly Alzheimer’s test

A blood test being developed by Roche and Eli Lilly that could help diagnose patients with Alzheimer’s disease more quickly has been awarded breakthrough status by the FDA

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EU pharma reform package clears key Parliament vote

The European Parliament has voted through reforms to legislation regulating the pharma sector, which the industry claims could compromise competitiveness and patient care

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Roche gets EU okay for first HER2-low test kit

Roche has obtained a CE Mark in the EU for a companion diagnostic that can be used to identify patients with HER2-low metastatic breast cancer who may be eligible for trea

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UK calls time-out on post-Brexit rules opposed by industry

It has been more than four years since the UK left the EU, but the government is still being forced to delay the introduction of border control rules that could have conse

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Sarah was born with ADA-SCID but was fortunate to access gene therapy via a clinical trial

NHS trust bids to take license for abandoned gene therapy

An NHS trust has taken the pioneering step of applying to hold the marketing authorisation for a gene therapy for a rare disease that was abandoned by a biotech developer

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Study points to weaknesses in FDA accelerated approval path

Less than half of the cancer therapies that were granted accelerated approval by the FDA between 2013 and 2017 showed a clinical benefit in a confirmatory trial within the

FDA puts breakthrough tag on Roche, Lilly Alzheimer’s test

EU pharma reform package clears key Parliament vote

Roche gets EU okay for first HER2-low test kit

UK calls time-out on post-Brexit rules opposed by industry

NHS trust bids to take license for abandoned gene therapy

Study points to weaknesses in FDA accelerated approval path

BridgeBio gains on phase 3 dwarfism data

How to meet your physicians where they are online

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