Novartis would like to avoid another data manipulation scandal

It’s been a rough few weeks for Novartis, which is still trying to appease angry regulators and contain the scandal around its failure to notify the FDA when it learned that data supporting its gene therapy Zolgensma had been manipulated.

That’s why the company announced at an investor meeting yesterday a new policy meant to prevent this mess from happening again: a commitment to notify the FDA within five business days of learning about any “credible allegation” involving manipulated data that could affect a pending marketing application.

STAT’s Ed Silverman has more.