Corcept Therapeutics Inc., of Menlo Park, Calif., submitted its new drug application (NDA) for Corlux in Cushing's syndrome, with a request for priority review

Corcept Therapeutics Inc., of Menlo Park, Calif., said it will submit its new drug application for Corlux in Cushing's syndrome to the FDA the week of April 11 and will request priority review

The FDA granted priority review to Celgene Corp., of Summit, N.J., for its supplemental new drug application for Istodax (romidepsin) for peripheral T-cell lymphoma, based on results of a multicenter, open-label study of the drug presented at the 2010 meeting of the American Society of Hematology

The FDA granted the drug a six-month priority review, with a PDUFA date of May 30

Vertex Pharmaceuticals Inc., of Cambridge, Mass., said the FDA accepted its new drug application for telaprevir and agreed to a six-month priority review, setting a PDUFA target review date of May 23...Telaprevir is Vertex's lead compound for patients with genotype 1 chronic hepatitis C. Vertex also completed a new drug submission to the Therapeutic Product Directorate of Health Canada seeking approval for telaprevir, which also was granted priority review in Canada

King Pharmaceuticals Inc., of Bristol, Tenn., and Acura Pharmaceuticals Inc., of Palatine, Ill., announced that King has submitted a new drug application for Acurox (oxycodone HCl) tablets to the FDA, including a request for priority review classification

Human Genome Sciences Inc., of Rockville, Md., and its partner GlaxoSmithKline plc, of London, reported that the FDA extended the PDUFA date for priority review of the biologics license application for Benlysta (belimumab) as a potential treatment for systemic lupus erythematosus from Dec. 9, 2010, to March 10, 2011

Optimer applied for priority review, which could lead to an FDA decision in the second quarter of 2011. (See BioWorld Today, Sept. 22, 2010

The application is being submitted on a rolling basis, following receipt of fast-track status from the FDA, and the BLA requests a six-month priority review

The application is being submitted on a rolling basis, following receipt of fast-track status from the FDA, and the BLA requests a six-month priority review

Salix Pharmaceuticals Ltd., of Raleigh, N.C., said that the FDA has extended its target action date for completing a priority review of Xifaxan (rifaximin) 550-mg tablets as a potential treatment of nonconstipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating

The FDA gave the application priority review status and set an action date of Jan. 7, 2011

The FDA gave the application priority review status and set an action date of Jan. 7, 2011

Endo Pharmaceuticals Inc., of Chadds Ford, Pa., said its new drug application for its new oral formulation of long-acting oxymorphone, a semisynthetic opioid analgesic designed to be crush resistant, was granted priority review status by the FDA, which assigned a Prescription Drug User Fee Act action date of Jan. 7, 2011

Alimera Sciences Inc., of Atlanta, said that the company's new drug application (NDA) for Iluvien (fluocinolone acetonide) intravitreal insert has been accepted for filing and granted priority review status by the FDA...With priority review, Alimera could receive a response from the FDA in the fourth quarter regarding its NDA for Iluvien, which was submitted at the end of June

Human Genome Sciences Inc., of Rockville, Md., and partner GlaxoSmithKline plc, of London, said the FDA granted priority review designation to Benlysta (belimumab) in systemic lupus erythmatosus and assigned a Dec. 9 PDUFA date

The company also said that the application has been granted a priority review designation by the FDA...Based on FDA's six-month goal for completing priority reviews, the projected FDA action date is Dec. 25

Salix Pharmaceuticals Ltd., of Raleigh, N.C., said the FDA has accepted for priority review the efficacy supplement to the firm's new drug application for Xifaxan (rifaximin) 550 mg as a treatment for nonconstipation irritable bowel syndrome (IBS), including patients with diarrhea-predominant symptoms and those who experience intermittent periods of diarrhea and constipation, known as mixed IBS, and IBS-related bloating

Merck Serono AG, of Geneva, a division of Merck KGaA, received a six-month priority review from the FDA for the oral multiple sclerosis drug cladribine