Novartis: taking action after data manipulation scandal
(CercleFinance.com) - In a letter to the FDA, Novartis has reiterated its "firm commitment" to data integrity and transparency with regulators after the data manipulation scandal that broke out over the summer.
The conclusion of its investigation is that two founders of its AveXis unit have altered, or instructed others to alter, raw data during clinical trials on gene therapy Zolgensma.
"Such conduct is unacceptable, and the two AveXis senior executives' (contracts) have been terminated," the Basel-based group said in the letter to the FDA.
Novartis said it has taken actions to prevent data integrity issues from occurring in the future, making a voluntary commitment to notify the FDA within five business days of receipt of any credible allegation related to data integrity impacting pending applications.
The company plans to take a similar approach in other jurisdictions.
Zolgensma, a gene therapy for children with spinal muscular atrophy, has been recently approved by the FDA, but AveXis has subsequently informed health regulators about "data manipulation" impacting the accuracy of data regarding the product.
Copyright (c) 2019 CercleFinance.com. All rights reserved.
The conclusion of its investigation is that two founders of its AveXis unit have altered, or instructed others to alter, raw data during clinical trials on gene therapy Zolgensma.
"Such conduct is unacceptable, and the two AveXis senior executives' (contracts) have been terminated," the Basel-based group said in the letter to the FDA.
Novartis said it has taken actions to prevent data integrity issues from occurring in the future, making a voluntary commitment to notify the FDA within five business days of receipt of any credible allegation related to data integrity impacting pending applications.
The company plans to take a similar approach in other jurisdictions.
Zolgensma, a gene therapy for children with spinal muscular atrophy, has been recently approved by the FDA, but AveXis has subsequently informed health regulators about "data manipulation" impacting the accuracy of data regarding the product.
Copyright (c) 2019 CercleFinance.com. All rights reserved.