Paper by European regulators foresees "continuing reduction in clinical data requirements" for biosimilars

24 September 2019 - This month, Elena Wolff-Holz, chair of the EMA’s Biosimilar Medicinal Products Working Party, together with co-authors from ...

Read more →

Susan G. Komen Big Data for Breast Cancer Initiative: how patient advocacy organisations can facilitate using big data to improve patient outcomes

12 September 2019 - Integrating different types of data, including electronic health records, imaging data, administrative and claims databases, large data ...

Read more →

The startup that manipulated data to get a miracle drug to market

14 September 2019 - AveXis had a revolutionary gene therapy for babies with a deadly disease, and sold to Novartis for ...

Read more →

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 ...

Read more →

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. ...

Read more →

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 ...

Read more →

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.  ...

Read more →

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 ...

Read more →

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. ...

Read more →

The evolution of real world studies

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

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →

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 ...

Read more →