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Novartis Ophthalmics Canada announced that Health Canada has granted priority review to Lucentis (ranibizumab), a treatment for neovascular (wet) age-related macular degeneration (AMD).
Genta announced that the FDA has notified the company that it has extended the review period for the pending new drug application (NDA) for Genasense (oblimersen sodium) Injection plus chemotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
Anesiva announced it has initiated Phase I clinical testing of product candidate 1207, a new topical local anesthetic for the potential treatment of numerous pain conditions, including neuropathic pain.
Tanox has begun dosing in a Phase I clinical trial of TNX-650, a humanized monoclonal antibody being evaluated as a potential treatment for moderate-to-severe asthma.
New clinical data on the hepatitis C virus (HCV) polymerase inhibitor R1626 -- currently being developed by Roche -- show viral reductions greater than those described for other polymerase inhibitors, according to data presented at the 57th Annual Meeting of the American Association for the Study of Liver Diseases.
Aspreva Pharmaceuticals has announced that, based on a preliminary review of trial data, CellCept (mycophenolate mofetil or MMF) in treating myasthenia gravis (MG) failed to meet both primary and secondary endpoints in a Phase III trial.
Paion announced that the independent data monitoring committee (DMC) for the company's DIAS-2 Phase III study met and informed the steering committee, Paion and its development partner for desmoteplase, Forest Laboratories, that it has reviewed the cumulative data from the study provided by the companies and recommended that patient enrollment resume with no modification of the protocol.
Impax Laboratories announced that the FDA has approved the company's abbreviated new drug application (ANDA) for a generic version of Colestid Tablets (colestipol hydrochloride), 1 gram.