Blog
RSS FeedPosted by Michael Wonder on 23 Aug 2019
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. ...
Posted by Michael Wonder on 21 Aug 2019
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 ...
Posted by Michael Wonder on 20 Aug 2019
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. ...
Posted by Michael Wonder on 20 Aug 2019
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 ...
Posted by Michael Wonder on 13 Aug 2019
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. ...
Posted by Michael Wonder on 11 Aug 2019
The evolution of real world studies
9 August 2019 - The use of real-world evidence is evolving quickly. ...
Posted by Michael Wonder on 06 Aug 2019
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 ...
Posted by Michael Wonder on 06 Aug 2019
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 ...
Posted by Michael Wonder on 21 Jul 2019
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 ...
Posted by Michael Wonder on 16 Jul 2019
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15 July 2019 - Just over two months ago, the US FDA released draft guidance explaining to drugmakers what constitutes ...
Posted by Michael Wonder on 04 Jul 2019
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 ...
Posted by Michael Wonder on 13 May 2019
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 ...
Posted by Michael Wonder on 27 Feb 2019
Patient experience data and bias — what ratings don’t tell us
28 February 2018 - Although patient-experience data are important to U.S. health care organisations, the best way to interpret them remains ...
Posted by Michael Wonder on 19 Feb 2019
Big opportunities in big data, but EMA and industry just getting started
18 February 2019 - 250m genomes sequenced, but data trapped in silos. ...
Posted by Michael Wonder on 15 Feb 2019
Role of big data for evaluation and supervision of medicines in the EU
15 February 2019 - Recommendations for a path towards understanding the acceptability of evidence derived from ‘Big data’ in support ...