• AI
  • Molecular Imaging
  • CT
  • X-Ray
  • Ultrasound
  • MRI
  • Facility Management
  • Mammography

Pharmacyclics agent to be delayed

Article

Pharmaceutical developer Pharmacyclics of Sunnyvale, CA, reported last week that it will experience a major delay in commercializing its Gadolite oral MRI contrast in the U.S. while it conducts additional stability tests on the product, which is designed

Pharmaceutical developer Pharmacyclics of Sunnyvale, CA, reported last week that it will experience a major delay in commercializing its Gadolite oral MRI contrast in the U.S. while it conducts additional stability tests on the product, which is designed for bowel delineation. The company said the studies are in response to meetings with Food and Drug Administration regulators.

Gadolite's commercialization is expected to be delayed by at least 18 months as Pharmacyclics conducts the additional studies. The company filed a new drug application for Gadolite in 1995 and received an approvable letter last December, although the FDA had additional questions about the filing that led to last week's decision to conduct further testing. Pharmacyclics has granted North American and European marketing rights for Gadolite to E-Z-EM of Westbury, NY.

In announcing the delay, Pharmacyclics president and CEO Dr. Richard Miller said that Gadolite is of a lesser priority than the company's cancer therapeutic products, Gd-Tex and Lu-Tex, which use Pharmacyclics' core texaphyrin technology. The company will, however, conduct the additional testing required to get Gadolite to market, he said.

Although Gadolite was granted marketing authorization in the U.K. last December, Pharmacyclics said that the status of a product launch in the U.K. and in other European countries was uncertain at this time.

The company's stock dropped two points, or 11%, on March 27, the day after the news was released, to close at $16.25 a share.

Recent Videos
Pertinent Insights into the Imaging of Patients with Marfan Syndrome
What New Brain MRI Research Reveals About Cannabis Use and Working Memory Tasks
Current and Emerging Legislative Priorities for Radiology in 2025
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 2
A Closer Look at the New Appropriate Use Criteria for Brain PET: An Interview with Phillip Kuo, MD, Part 2
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 1
A Closer Look at the New Appropriate Use Criteria for Brain PET: An Interview with Phillip Kuo, MD, Part 1
Teleradiology and Breast Imaging: Keys to Facilitating Personalized Service, Efficiency and Equity
Current and Emerging Insights on AI in Breast Imaging: An Interview with Mark Traill, MD, Part 3
Current and Emerging Insights on AI in Breast Imaging: An Interview with Mark Traill, MD, Part 2
Related Content
© 2025 MJH Life Sciences

All rights reserved.