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FDA

This page shows the latest FDA 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 undercuts price of Bayer cancer drug after winning FDA approval

The FDA approvals of Rozlytrek and Vitrakvi cover all patients with NTRK gene fusions, regardless of where the tumour is located in the body. ... Roche is working with Foundation Medicine to prepare a filing for FDA approval of the companion diagnostic,

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  • The evolution of real-world studies The evolution of real-world studies

    Ned Sharpless, Acting FDA Commissioner. Similar discussions are taking place across the Atlantic. ... Elsewhere, the EMA has compared the FDA’s real-world Sentinel safety system favourably to.

  • Real-world studies Real-world studies

    Advances like that which we saw in November last year, when the FDA unveiled its own MyStudies app for the collection of real-world data, will continue to drive the use

  • Streamlining clinical trials – why better data use is key Streamlining clinical trials – why better data use is key

    Big data, blockchain technology and artificial intelligence have given industry the chance to streamline drug trials, say experts, who agree with recent FDA calls for more efficient clinical research models. ... Dr Scott Gottlieb’s brief, energetic

  • 25 Women Leaders in UK Healthcare 25 Women Leaders in UK Healthcare

    Ruth has more than 80 publications to her name, and led the first genome-wide FDA submission of a hepatic adverse event and the first tumour-based analysis of an AstraZeneca

  • Rare disease trials Q&A Rare disease trials Q&A

    In its updated draft guidance on rare diseases published in February 2019, the US Food and Drug Administration (FDA) encourages pharma companies to involve patients, caregivers.

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