1. Pink Sheet
  2. >>Advanced Technologies
  3. >>Cell & Gene Therapies

Novartis CEO Explains Delay In Telling US FDA About Zolgensma Data Fraud: We Wanted To Understand It First

 
• By Derrick Gingery

Novartis is in the process of "exiting" the "small number" of scientists involved in the fraud, CEO Narasimhan says.

Decorin protein
Novartis' Rob Kowalski said the company investigated the zolgensma fraud as prescribed in internal policies. • Source: Shutterstock

Novartis AG tried to squash any thoughts that it had a nefarious intent in not disclosing the data fraud it knew about before approval of its gene therapy Zolgensma, saying the company wanted a full understanding of the issue first before bringing it to the attention of regulators.

CEO Vasant Narasimhan said during a 7 August conference call with analysts that the company determined safety, efficacy, and quality...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Cell & Gene Therapies

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 
• By Sarah Karlin-Smith

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

Cell/Gene Therapy Cost Recovery Options Could Include Pre-Approval Public ‘Bridge’ Funding

 
• By Kate Rawson

Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.

Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
• By Sarah Karlin-Smith

The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

More from Advanced Technologies

Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 
• By Natasha Barrow

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.

Australia Looks To Modernize Human Tissue Laws, Improving Access For Researchers

 
• By Eliza Slawther

Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.