New “21st Century Cures” legislation: speed and ease versus science

5 January 2017 - The 21st Century Cures Act was signed into law in December 2016. Praised by its advocates as ...

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The changing face of clinical trials: the large pharmaceutical company perspective

4 January 2017 - Large pharmaceutical companies conduct clinical trials to evaluate efficacy and identify safety issues for candidate drugs as ...

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FDA completes guidance on the development of biosimilars

29 December 2016 - Drug makers received guidance from the FDA on 28 December on the development of biosimilar medicines. ...

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Negative control outcomes: a tool to detect bias in randomised trials

27 December 2016 - Investigators have several design, measurement, and analytic tools to detect and reduce bias in epidemiological studies. One ...

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FDA officials call for including adolescents in adult oncology trials

20 December 2016 - A team of officials at the US FDA are calling for a "culture shift" by drug ...

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Harnessing the U.S. taxpayer to fight cancer and make profits

19 December 2016 - Enthusiasm for cancer immunotherapy is soaring, and so is Arie Belldegrun’s fortune. ...

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A new type of molecular medicine may be needed to halt cancers

16 December 2016 - Doctors must look to proteins rather than genes to tackle tumours. ...

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Transforming evidence generation to support health and health care decisions

14 December 2016 - Making better choices about health and health care requires the best possible evidence. Unfortunately, many of the ...

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The 21st Century Cures Act — a view from the NIH

14 December 2016 - The Cures Act, formally known as H.R. 34 or the 21st Century Cures Act, passed overwhelmingly in ...

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Obama signs $6.3 billion law for cancer research, drug treatment

14 December 2016 - President Barack Obama has signed into law legislation that makes new investments in cancer research and battling ...

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Interpreting geographic variations in results of randomised, controlled trials

7 December 2016 - Clinical triallists generally accept the premise that surprising results in subgroups of a randomised, controlled trial most ...

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1 patient, 7 tumours and 100 billion cells equal 1 striking recovery

7 December 2016 - The remarkable recovery of a woman with advanced colon cancer, after treatment with cells from her ...

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Quality of life, overall survival, and costs of cancer drugs approved based on surrogate endpoints

29 November 2016 - The lack of evidence of a clinically meaningful benefit for many cancer drugs approved by the US ...

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Republicans reach deal to pass Cures Act by end of year, but Democrats pushing for changes

27 November 2016 - House and Senate leaders announced late Friday night that they had finally hammered out a deal ...

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FDA research to help speed development of Zika virus vaccines and therapeutics

17 November 2016 - Neonatal mouse model provides a new platform for Zika virus research. ...

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