Ousted Novartis scientist ‘categorically denies’ wrongdoing in data manipulation scandal

20 August 2019 - The scientist, Brian Kaspar, “is a respected member of the scientific community with an impeccable record,” his ...

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DNA data shared in ways patients may find surprising

12 August 2019 - Hospitals engaged in private deals with drugmakers don’t always disclose the ways the data will be used. ...

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The evolution of real world studies

9 August 2019 - The use of real-world evidence is evolving quickly. ...

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Big data, big tech, and protecting patient privacy

9 August 2019 - The market for patient data has never been more active.  ...

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Insurers snooping in our health records

9 August 2019 - Life insurers have trawled through the medical records of 150,000 Australians in an attempt to deny ...

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Novartis hid manipulated data while seeking approval for $2.1 million treatment

6 August 2019 - The failure to report the issue has not put patients at risk, the F.D.A. said, but the ...

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Statement on data accuracy issues with recently approved gene therapy

6 August 2019 - As a public health agency, we believe that it is critical to facilitate the development of ...

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Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices

21 July 2019 - The objective was to develop and pilot a tool to measure and improve pharmaceutical companies’ clinical trial ...

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Gilead and Novartis seek to expand what FDA considers as real-world data and real-world evidence

15 July 2019 - Just over two months ago, the US FDA released draft guidance explaining to drugmakers what constitutes ...

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Academies call on health minsters to resolve health data issues

15 July 2019 - Regulatory barriers that limit timely access to population and health data must be resolved to achieve ...

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Attempt to replicate clinical trials with real world data generates real world criticism, too

3 July 2019 - It’s one of the most seductive ideas in medicine: that “real-world evidence,” including data from electronic ...

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NICE explores extending its use of data to inform its guidance

25 June 2019 - NICE has revised its earlier press release on the use of real world data to inform ...

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Use real world data, not international reference pricing to set US drug prices

25 June 2019 - The Trump administration has proposed using international reference pricing for medicines.  ...

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Two words to help Ned Sharpless revolutionise clinical trials: data standards

13 May 2019 - In the classic 1967 film “The Graduate,” young Benjamin Braddock was given one word of advice ...

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Rx drug costs: list prices versus net prices and the importance of staying within the data

13 March 2019 - The authors of a recent Health Affairs article asked a meaningful question: Are new drugs or ...

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