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Volume 1, Number
5
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September 2005
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| Contents: | ||||
| WELCOME | ||||
| THE LATEST RESEARCH | ||||
| NOTEWORTHY: GENENTECH TO FILE FOR FDA APPROVAL OF RANIBIZUMAB THIS YEAR; WORK ON RNAi AMD THERAPY HALTED; AND MORE ITEMS OF INTEREST | ||||
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THE LATEST RESEARCH
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| NOTEWORTHY: GENENTECH
TO FILE FOR FDA APPROVAL OF RANIBIZUMAB THIS YEAR; WORK
ON RNAi AMD THERAPY HALTED; AND MORE
ITEMS OF INTEREST Genentech to File for FDA Approval of Ranibizumab This Year Genentech, Inc. plans to file a complete Biologics License Application (BLA) for ranibizumab (Lucentis) in December of this year. In addition, the company is discussing with the FDA plans for a Phase IIIb study called SAILOR (Safety Assessment of Intravitreal Lucentis for AMD). The study is being designed to evaluate the safety of two different doses (0.3 mg and 0.5 mg) in a broad wet AMD population. It will be conducted at more than 100 sites in the United States and involve approximately 5,000 patients. Recently, the FDA denied Genentechs request for fast-track designation for ranibizumab, but the company said that decision will not affect the timing of the December BLA submission or the potential to obtain priority review. Source: Genentech Inc., September 2005. Work on RNAi AMD Therapy Halted In light of the efficacy reported from recent Phase III trials of competing drugs, Alnylam Pharmaceuticals, Inc. has decided to suspend further development of ALN-VEG01, its RNAi therapeutic candidate that targets VEGF in the treatment of AMD. It will allocate resources to other potential products in its pipeline, such as its RNAi therapy for respiratory syncytial virus. ALN-VEG01 had been expected to enter Phase I clinical trials in the second half of this year. The development program was a collaboration with Merck. An Alnylam executive said the two companies would continue to work together on the discovery of other RNAi therapeutics for the treatment of ocular disease. Source: Alnylam Pharmaceuticals Inc., September 2005. Batches of Trypan Blue Dye Recalled Minnesota-based Custom-RX Compounding Pharmacy initiated a recall of Trypan Blue 0.06% ophthalmic solution because it may be contaminated with Pseudomonas aeruginosa. The staining agent was distributed to hospitals and clinics in Maryland, Minnesota, Illinois, Nebraska, North Dakota, Michigan, Pennsylvania and the District of Columbia. The recall includes, but may not be limited to, the following lot numbers: 05042005:86@17, 05252005:36@13, 06282005:91@27, 08012005:63@24, and 08182005:43@17. The recall is based on a positive bacterial culture from a hospital and two reports to the Centers for Disease Control of vision loss possibly associated with use of the product. For more information, contact Verne Betlach at (612) 866-2211. Source: Custom RX Compounding Pharmacy, August 2005. |
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