Blog
RSS FeedPosted by Michael Wonder on 12 Oct 2019
Canada's decision to make public more clinical trial data puts pressure on FDA
11 October 2019 - Last March, Canada's department of health changed the way it handles the huge amount of data ...
Posted by Michael Wonder on 01 Oct 2019
FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software
1 October 2019 - Today, the U.S. FDA is informing patients, health care professionals, IT staff in health care facilities and ...
Posted by Michael Wonder on 25 Sep 2019
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 ...
Posted by Michael Wonder on 18 Sep 2019
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 ...
Posted by Michael Wonder on 15 Sep 2019
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 ...
Posted by Michael Wonder on 09 Sep 2019
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 ...
Posted by Michael Wonder on 25 Aug 2019
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 ...
Posted 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
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, ...
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 10 Aug 2019
Big data, big tech, and protecting patient privacy
9 August 2019 - The market for patient data has never been more active. ...