Reeling from scandal, Novartis vows to voluntarily release info on manipulated data in the future

9 September 2019 - Seeking to appease angry regulators, Novartis committed to notifying the FDA within five business days of ...

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Australia could be world leader with its digital medical data banks

26 August 2019 - Australia is behind global peers in adopting technology in healthcare but it has an opportunity to ...

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FDA focuses on Novartis delay in reporting drug-test data manipulation

22 August 2019 - Regulators zeroing in on the company’s two-month delay in launching a formal inquiry. ...

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Chinese stealing health and medical research data: report

21 August 2019 - The global healthcare sector, including Australia, faces increasing cyber threats and malicious activity from Chinese groups, ...

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FDA on Novartis data manipulation controversy: ‘we happened to be lucky’

21 August 2019 - Since the FDA blasted Novartis earlier this month over data manipulation, one of the major questions ...

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Novartis delayed reveal of bad data for $2.1 million gene therapy. Now patients and pharma suffer.

20 August 2019 - Novartis CEO had a rocky start to his tenure.  ...

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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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