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Novartis drug appears effective in liver transplant patients

BY Alaric DeArment

EAST HANOVER, N.J. — An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

A phase-3 study published in the American Journal of Transplantation found that patients taking RAD001 (everolimus) with a reduced dose of Astellas’ Prograf (tacrolimus) experienced equal efficacy and superior kidney function to patients taking Prograf alone.

Novartis markets everolimus for various cancers and for kidney transplant patients under the trade names Afinitor and Zortress, respectively. The drug has not received Food and Drug Administration approval for liver transplant patients, which is why Novartis is using the code name RAD001 for the study, the company said.


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FDA approves Genentech’s Lucentis for diabetic macular edema

BY Alaric DeArment

SILVER SPRING, Md. — Regulators have approved a biotech drug made by Genentech for treating a complication related to diabetes.

The Food and Drug Administration approved Lucentis (ranibizumab) for diabetic macular edema, a cause of vision loss in people with diabetes. The drug already was approved for age-related macular degeneration.

"Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema," FDA Division of Transplant and Ophthalmology Products director Renata Albrecht said. "Today’s approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease."

According to the Centers for Disease Control and Prevention, Type 1 and Type 2 diabetes affect about 26 million people in the United States and are the leading cause of blindness among people ages 20 to 74 years. In 2010, 3.9 million adult diabetics reported vision problems. DME happens when fluid leaks into the macula, the central part of the retina where sharp, straightforward vision occurs.


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NPA to launch new webinar series

BY Michael Johnsen

WASHINGTON — The Natural Products Association on Wednesday announced the creation of a new webinar series, “Regulatory Trainings Straight from Your Desk,” that will begin Aug. 22 with an education session about good manufacturing practices for own-label distributors, repackagers and relabelers.

Expert speakers include Daniel Fabricant, director of the FDA Division of Dietary Supplement Programs, and Cindy Beehner, president of QSD Consulting.

“We at NPA are proud to continue our leadership role in providing quality education for the dietary supplement industry,” said Cara Welch, SVP scientific and regulatory affairs for NPA. “With the FDA’s increasing number of facility inspections, combined with recent scrutiny of supplement manufacturing practices, it’s vitally important that the industry do everything possible to come into compliance with the GMP rule.”

An NPA webinar about product labeling will be held in two parts on Oct. 16 and Oct. 18 with industry labeling expert Richard Flora, president of R. Flora & Associates. Participants will learn how to avoid a warning letter for labeling issues or product claims and how to correctly use claims to educate customers about products without making them “unapproved new drugs.”


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