1. In Vivo
  2. >>Archive

D-Day for Abbott

Abbott Laboratories' consent decree with the FDA, which requires it to pull 125 diagnostic tests off the market, doesn't only hurt Abbott. Abbott controls 40-50% of the immunoassay market worldwide, so the decree places a significant burden on customers as well.

January 10 is D-Day for Abbott Laboratories Inc. to pull 125 diagnostics tests off the market as part of its consent decree with the FDA (See "Abbott Gets into Hot Water," IN VIVO, November 1999). The decree, which follows the FDA's accusation that Abbott used shoddy manufacturing processes in its main US-based manufacturing plants, is unprecedented—and hurts far more than Abbott alone.

Given that Abbott controls 40-50% of the immunoassay market worldwide, the decree places a significant burden on customers. According to...

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
Start Free Trial

Already a subscriber?

More from Archive

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

 
• By Eleanor Malone

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

 
• By Eliza Slawther

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

 
• By Eleanor Malone

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

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.

Rising Leaders 2025: Ovid’s Meg Alexander On Neurology’s Next Frontier

 
• By Jo Shorthouse

Ovid Therapeutics' president and COO Meg Alexander is leading the company’s strategic pivot toward innovative neurological treatments, potentially creating a new class of medicines for rare neurological disorders.

The Goldilocks Isotope: Perspective Therapeutics’ ‘Just Right’ Alpha Radiotherapeutic

 
• By David Wild

Thijs Spoor's bet on lead-212 is paying off as Perspective Therapeutics advances three clinical programs with promising early efficacy signals and a comprehensive manufacturing strategy.