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Bristol-Myers Squibb (BMS) has announced results of the double-blind phase of an ongoing study, which show Orencia (abatacept) demonstrated improvement in children with active juvenile idiopathic arthritis (JIA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate or TNF antagonists, as measured by the ACR's Pediatric (ACR Pedi) criteria for improvement of JIA.
ZymoGenetics and Serono presented positive results from a Phase Ib study in systemic lupus erythematosus (SLE) patients treated with atacicept at the American College of Rheumatology annual meeting.
Isis Pharmaceuticals presented results from two Phase II clinical trials of ISIS 301012 p at the American Heart Association Annual Scientific Sessions in Chicago.
NicOx announced that the FDA has given the company feedback on the requirements for long-term safety data needed for the submission of a new drug application (NDA) for naproxcinod (HCT 3012).
Eli Lilly has announced results from a three-year Phase III clinical trial in which ruboxistaurin mesylate (proposed brand name Arxxant) reduced the risk of sustained moderate vision loss by 40 percent when compared with placebo in patients with moderate to severe non-proliferative diabetic retinopathy.
Taro Pharmaceutical Industries has received approval from the FDA for its abbreviated new drug application (ANDA) for meloxicam tablets, 7.5 and 15 mg.
Mylan Laboratories announced that the FDA has granted final approval to Mylan Pharmaceuticals's abbreviated new drug application (ANDA) for oxybutynin chloride extended-release tablets, 5 and 10 mg.
Impax Laboratories announced that the FDA has granted final approval to its abbreviated new drug application (ANDA) for a generic version of Ditropan XL (oxybutynin chloride) Extended-Release Tablets, 15 mg.
Dendreon announced that the final portion of the biologics license application (BLA) for Provenge (sipuleucel-T) has been electronically submitted to the FDA, which completes the rolling submission that began in August.