regulatory

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Apple gets FDA okay to use AFib tool in clinical trials

The atrial fibrillation (AFib) detection feature on Apple Watch devices has become the first digital health technology to be qualified under a programme recently introduce

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MHRA ‘sandbox’ to pilot AI regulation will go live soon

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has said it will launch a pilot programme in the coming weeks to see how it can evolve the regulation o

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CSL Vifor offers campaign to mollify EC in antitrust probe

CSL Vifor has said it is prepared to carry out a “comprehensive and multi-channel communication campaign” to address allegations by the EU that it disparaged one of its co

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FDA fast-tracks AskBio’s heart failure gene therapy

A gene therapy for heart failure being developed by Bayer’s AskBio unit has been granted fast-track status by the FDA, shortly after it showed preliminary signs of efficac

Digital

navigating intellectual property challenges

Risk management strategies to navigate IP challenges associa...

Artificial intelligence (AI) is revolutionising industries. But with this exciting new frontier comes a complex challenge: protecting your intellectual property (IP).

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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

Apple gets FDA okay to use AFib tool in clinical trials

MHRA ‘sandbox’ to pilot AI regulation will go live soon

CSL Vifor offers campaign to mollify EC in antitrust probe

FDA fast-tracks AskBio’s heart failure gene therapy

Risk management strategies to navigate IP challenges associa...

EU pharma reform package clears key Parliament vote

FDA set to raise bar for clinical trials of CAR-T therapies

How to meet your physicians where they are online

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