Novartis and the Innovator's Dilemma

Novartis' most important new drug candidate, the innovative irritable bowel syndrome drug tegaserod, has been rejected by both European and US regulatory agencies. But while it and other drug firms may blame regulatory groups for becoming too risk averse, or for worrying about the costs of drug treatment, it's just as likely a problem of innovation. The agencies know how to deal with me-too drugs--it's the breakthroughs that are problematic.

As IN VIVOwent to press, we received news that the Food & Drug Administration had rejected Novartis AG 's application for approval of tegaserod (Zelnorm), arguably the company's most important new drug and the only important treatment on the near-horizon for irritable bowel syndrome (IBS). The blow is doubly devastating for the company, coming as it does just weeks after Novartis withdrew the drug's marketing application in Europe when the European Medicines Evaluation Agency (EMEA) appeared ready to deny it approval.

Reaction was predictable. Novartis shares have fallen about 10% since the EMEA meeting—the delays will cost the company, if analysts' projections for the drug are correct, a minimum of several...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo 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

More from Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

Shape Our Content: Take The Reader Survey

 

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

More from In Vivo

US Health System Redesign Critical, NAM’s Medical Experts Warn Trump Government

 
• By 

The whirlwind back-and-forth on US tariffs and Robert F. Kennedy jr.’s plans to deregulate health care have become all-preoccupying, but the National Academy of Medicine was first to set out President Trump’s health administration priorities.

Podcast: “Powerful Yet Unexplored”: Commit Biologics Tackles The Complement System

 

Mikkel Wandahl Pederson, CEO and chief scientific officer at Commit Biologics, discussed the company’s mission to harness the powerful complement system for the treatment of serious diseases.

ML-Assisted Genetic Risk Score Predicts GLP-1 Adverse Events

 
• By 

Phenomix Science presented new data at Digestive Disease Week 2025 showing its machine learning-assisted genetic risk score can predict nausea and side effects from GLP-1 receptor agonists, aiding personalized obesity treatment.