Blog
RSS FeedPosted by Michael Wonder on 06 Nov 2019
One shot drug to end Sicilian curse comes at $1.8 million cost
5 November 2019 - A new targeted gene therapy shows the promise and pitfalls of medical advances. ...
Posted by Michael Wonder on 22 Oct 2019
Moderna receives FDA fast track designation for propionic acidemia program (mRNA-3927)
22 October 2019 - mRNA-3927 is Moderna’s second rare disease program to receive fast track designation. ...
Posted by Michael Wonder on 24 Sep 2019
Novartis unit says FDA wasn’t told of data manipulation sooner because it was ‘highly complex’
25 September 2019 - If you were wondering why Novartis waited more than three months to notify the Food and ...
Posted by Michael Wonder on 24 Sep 2019
FDA grants paediatric disease designation for Mateon's OT101
23 September 2019 - For treatment of diffuse intrinsic pontine glioma, a difficult to treat form of childhood brain tumour. ...
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 04 Sep 2019
Magenta Therapeutics announces FDA regenerative medicine advanced therapy designation granted to MGTA-456 for the treatment of inherited metabolic disorders
4 September 2019 - Magenta Therapeutics today announced that the U.S. FDA granted regenerative medicine advanced therapy designation for MGTA-456, ...
Posted by Michael Wonder on 27 Aug 2019
An FDA report reveals the agency believed Novartis data problems were resolved months ago
27 August 2019 - Shortly before serious data problems surfaced in mid-March at a troubled Novartis unit, a Food and ...
Posted 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 ...