FDA rejects biotech co.’s non-Hodgkin’s lymphoma treatment
IRVINE, Calif. A biotech company focused on cancer treatments has received a rejection letter from the Food and Drug Administration for its application for a drug to treat non-Hodgkin’s lymphoma.
Spectrum Pharmaceuticals said the FDA rejected its application seeking approval for an additional use of Zevalin (ibritumomab tiuxetan), as a first-line consolidation treatment for NHL. The drug already has approval to treat patients with relapsed or refractory, low-grade or follicular B-cell NHL.
Spectrum said it would submit the additional data the FDA requested by Wednesday.
Biogen Idec, Acorda Therapeutics to develop, commercialize MS drug
CAMBRIDGE, Mass. Two drug makers have announced plans to develop and commercialize a multiple sclerosis treatment in markets outside the United States.
Biogen Idec and Acorda Therapeutics said the agreement to market Fampridine-SR (4-aminopyridine) was a sublicensing of an existing license agreement between Acorda and a subsidiary of Elan Corp. The drug is an orally administered, sustained-release drug being developed to improve walking ability in patients with MS.
Under the terms of the agreement, Biogen Idec will commercialize Fampridine-SR and other aminopyridine products in markets outside the United States, and also will have responsibility for regulatory affairs and future clinical development of the drug. In exchange, Acorda will receive an upfront payment of $110 million and additional payments of up to $400 million based on the successful achievement of future regulatory and sales milestones.
The companies said the Food and Drug Administration is reviewing a regulatory approval application for the drug for the U.S. market.
Study: Joint replacement patients with diabetes greatly benefit from controlled glucose
ROSEMONT, Ill. The risk of complications that diabetes patients often have when undergoing total joint replacement decreases when they have their glucose levels under control, according to a recent study.
Published in the July issue of The Journal of Bone and Joint Surgery, the study found that diabetics with uncontrolled glucose levels are more than three times as likely as those with their levels under control to experience a stroke or death after joint replacement surgery, and are approximately twice as likely to experience post-operative bleeding and infection.
“We found that controlled glucose levels really do make a difference for the patient,” Duke University Medical Center orthopedic surgeon and study co-author Milford Marchant said. “It did not matter if the patient had Type 1 or Type 2 diabetes.”