Genentech, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease. The supplemental approval is based on data that showed longer prophylactic treatment with Valcyte reduced the incidence of CMV disease in high-risk adult kidney transplant patients from 36.8 percent to 16.8 percent at one year after receiving a transplanted kidney.

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LifeCycle Pharma A/S has announced the enrollment of the first patient in its Phase 3 clinical trial program for use of LCP-Tacro™ in the prevention of organ rejection in stable kidney transplant patients. The clinical trial protocol has been reviewed by FDA, and LCP expects to enroll approximately 300 stable kidney transplant patients in the program. The study will be conducted at approximately 50 sites in U.S. and Europe and the clinical trial results are expected by second half of 2010.