Celator Pharmaceuticals Receives Orphan Drug Designation For Anticancer Agent CPX-351 Celator Pharmaceuticals announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to CPX-351 (Cytarabine:Daunorubicin) Liposome Injection for the treatment of Acute Myeloid Leukemia (AML). Celator is currently preparing to conduct two randomized Phase 2 studies with CPX-351. The first Phase 2 study, in newly diagnosed, elderly patients with AML, is expected to start enrolling patients before the end of 2008.
Source: www.medicalnewstoday.comFDA Approves First Hepatitis B Viral Load Test The U.S. Food & Drug Administration (FDA) has approved the Roche COBAS(R) TaqMan(R) HBV Test, the first assay for quantitating Hepatitis B Virus DNA approved in the U.S. The test uses Roche's real-time PCR technology to quantify the amount of Hepatitis B virus DNA in a patient's blood. Doctors may use viral load testing results to establish a baseline level of infection and during treatment as an aid in assessing individual responses to therapy.
Source: www.medicalnewstoday.comYouth In Rwanda That Head Households Commonly Depressed Of the orphaned youth who are heading households in rural Rwanda can be classified as depressed, according to a report released on September 1, 2008 in Archives of Pediatrics & Adolescent
Medicine, one of the JAMA/Archives journals. Rwanda has one of the largest groups of orphans in the world, a result of the 1994 genocide and the epidemic of HIV infection.
Source: www.medicalnewstoday.comSARcode And Sunesis Announce Start Of Phase 1 Clinical Trial In Ocular Inflammatory Diseases SARcode Corporation, a private company focused on small molecule LFA-1 inhibitors to treat inflammatory diseases, and Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced SARcode's initiation of a Phase 1 clinical trial of a small molecule LFA-1 product candidate for T-cell mediated ophthalmic diseases.
Source: www.medicalnewstoday.comNanotechnology And The FDA: Size Matters! The Food & Drug Administration (FDA) issued in July 2007 its Nanotechnology Task Force Report. This report acknowledged that nanoscale materials potentially could be used in most product types regulated by the agency and that those materials present challenges complicated by the fact that properties relevant to product safety and effectiveness may change as size varies within the nanoscale.
Source: www.medicalnewstoday.com
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