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
SNMMI: Emerging PET Insights on Neuroinflammation with Progressive Apraxia of Speech (PAOS) and Parkinson-Plus Syndrome
Improving Access to Nuclear Imaging: An Interview with SNMMI President Jean-Luc C. Urbain, MD, PhD
SNMMI: 18F-Piflufolastat PSMA PET/CT Offers High PPV for Local PCa Recurrence Regardless of PSA Level
SNMMI: NIH Researcher Discusses Potential of 18F-Fluciclovine for Multiple Myeloma Detection
SNMMI: What Tau PET Findings May Reveal About Modifiable Factors for Alzheimer’s Disease
Emerging Insights on the Use of FES PET for Women with Lobular Breast Cancer
Can Generative AI Reinvent Radiology Reporting?: An Interview with Samir Abboud, MD
Mammography Study Reveals Over Sixfold Higher Risk of Advanced Cancer Presentation with Symptom-Detected Cancers
Combining Advances in Computed Tomography Angiography with AI to Enhance Preventive Care
Study: MRI-Based AI Enhances Detection of Seminal Vesicle Invasion in Prostate Cancer
Related Content
© 2025 MJH Life Sciences

All rights reserved.