Blog
RSS FeedPosted by Michael Wonder on 24 Aug 2019
Life changing drugs almost nobody can afford
23 August 2019 - Patients suffering from rare diseases who had little hope for a treatment now have access 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
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 18 Aug 2019
Novartis CEO says FDA process could have been handled better
17 August 2019 - Novartis AG Chief Executive Officer Vas Narasimhan said the company could have handled a furore surrounding ...
Posted by Michael Wonder on 17 Aug 2019
As Sarepta awaits approval of new Duchenne drug, big questions hang over therapy already on market
15 August 2019 - As Sarepta Therapeutics waits for the FDA to announce an approval decision on a new drug ...
Posted by Michael Wonder on 14 Aug 2019
This drug will save children’s lives. It costs $2 million.
13 August 2019 - Safety, innovation and affordability need not be mutually exclusive goals for cutting-edge treatments. ...
Posted by Michael Wonder on 14 Aug 2019
Novartis violated FDA’s sacred principle: in God we trust, all others must bring data
14 August 2019 - A common saying at the Food and Drug Administration is: “In God we trust, all others ...
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 13 Aug 2019
Memo to the Novartis CEO: when in doubt, give the FDA a heads-up
13 August 2019 - For someone who has made a point of trying to steer Novartis away from scandal, Vas ...
Posted by Michael Wonder on 12 Aug 2019
Democratic senators urge FDA to take action against drug company that hid faulty data
9 August 2019 - A group of Democratic senators is urging the Food and Drug Administration (FDA) to take action ...
Posted by Michael Wonder on 06 Aug 2019
Novartis stands behind Zolgensma (onasemnogene abeparvovec-xioi) for the treatment of children less than 2 years of age with spinal muscular atrophy
6 August 2019 - Today the FDA released a statement addressing data integrity issues with the Biologics License Application (BLA) for ...
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 ...