Hackers steal Pfizer/BioNTech COVID-19 vaccine data in Europe, companies say

10 December 2020 - U.S. drug maker Pfizer and its German partner BioNTech said on Wednesday that documents related to development ...

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Deploying big data to determine how well vaccines work

29 November 2020 - As the initial rollout starts, it’s time to start planning a registry to monitor health outcomes. ...

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PHARMAC won’t release the data that changed its mind on diabetes

13 November 2020 - Diabetes Foundation Aotearoa will request the Ombudsman investigate the refusal by PHARMAC to release public submissions ...

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Worst-rank score methods—a non-parametric approach to informatively missing data

28 September 2020 - A previous JAMA Guide to Statistics and Methods article briefly reviewed non-parametric statistics.  ...

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Making best use of big data for public health: publication of the Big Data Steering Group workplan for 2020-21

14 September 2020 - The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies has ...

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F.D.A. ‘grossly misrepresented’ blood plasma data, scientists say

24 August 2020 - Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about ...

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FDA may fine clinical trial sponsors that don’t report data

24 August 2020 - The US FDA has said it will penalise sponsors of clinical trials that do not report ...

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EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication

1 June 2020 - In a response to officials at Germany’s IQWiG and the Cochrane Collaboration, EMA Executive Director Guido ...

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Federal scientists finally publish remdesivir data

23 May 2020 - A clinical trial led to the authorisation of the only drug shown to work in COVID-19 patients. ...

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Is your health data safe as My Health Record hacking revealed

20 May 2020 - The government's My Health Record platform was the target of an attempted hack last year, Australia's ...

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Regulatory and health technology assessment advice on post‐licensing and post‐launch evidence generation is a foundation for lifecycle data collection for medicines

11 March 2020 - The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially ...

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HHS finalises historic rules to provide patients more control of their health data

9 March 2020 - Final rules require access to health information, spur innovation and aim to end information blocking ...

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FDA launches new resource to provide easily accessible, more accurate historical drug approval data

21 February 2020 - FDA is launching a new resource to assist external and agency researchers collecting historical information about ...

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NICE plans to widen the net for data it uses in guidance

5 February 2020 - UK cost-effectiveness body NICE has said it intends to use a broader range of data and ...

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Broader types of data to be used in development of NICE guidance

4 February 2020 - An expanded evidence base could allow NICE to address evidence gaps and enhance reviews of the impact ...

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