1. Scrip
  2. >>Leadership

Novartis Battens Down Hatches Over Falsified Zolgensma Data

 
• By Kevin Grogan

The Swiss major believes it responded in a timely fashion to data manipulation issues associated with its closely watched gene therapy but CEO Vas Narasimhan's bid to rebuild trust with society has taken a hit.

Spartan_Defense
Novartis defends its actions over Zolgensma data probe • Source: Shutterstock

Accused of concealing manipulated data from the US Food and Drug Administration while applying for approval of its spinal muscular atrophy drug Zolgensma Novartis AG has moved quickly to vigorously defend the safety and efficacy of its expensive gene therapy treatment and its own corporate reputation.

Observers were stunned on 6 August by an FDA statement highlighting an investigation into data manipulation issues associated with the Swiss major's filing for Zolgensma (onasemnogene abeparvovec) which was approved in the US for type 1 SMA on 24 May

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 Leadership

More from Scrip

Finance Watch: Funding Alternatives Become The Norm In Tough Public Markets

 
• By Mandy Jackson

Public Company Edition: With fewer follow-on offerings, drug developers are pursuing other options. Axsome accessed up to $570m in debt, Evolus obtained $250m in a new credit facility and Abeona raised $155m from a PRV sale, but Apimeds was able to execute a small $13.5m IPO.

iTeos/GSK To Terminate Collaboration After TIGIT Trials Flop

 
• By Alaric DeArment

Belrestotug is the latest anti-TIGIT candidate to fail to meet expectations. iTeos said it will pursue strategic alternatives.

‘Market Developments’ Persuade Galapagos To Rethink Spin-Off

 
• By Andrew McConaghie

CEO Paul Stoffels exits early to be succeeded by Henry Gosebruch, who will now consider ‘all options’ for the Belgian firm as it tries to claw back investor confidence.