Detailed data were not released but the Raleigh, N.C.-based specialty pharma firm anticipates filing a new drug application by the end of September, seeking approval of the topical glucocorticosteroid in UP and UPS, forms of ulcerative colitis (UC) typically limited to the rectum – UPS refers to UC in the rectum and sigmoid colon – that are difficult to treat with existing oral and enema treatments

Upsher-Smith's new drug application for USL255 was accepted for review by the FDA with an anticipated PDUFA date in December 2013

The company expects to submit a new drug application for the NanoTab System in the third quarter...Perosphere Inc., of Mount Kisco, N.Y., said it received FDA clearance of its investigational new drug application to start clinical testing of PER977 to reverse the anticoagulant activity of unfractionated heparin, low-molecular-weight heparins, fondaparinux and Factor Xa- and IIa inhibitors

Baliopharm GmbH, a subsidiary of Baliopharm AG, of Basel, Switzerland, joined the NEU2 Consortium with a project addressing the recombinant manufacturing of an Fc-free bispecific CD20-CD95 antibody construct (Novotarg) with selectivity for activated B cells and efficacy studies in disease models relevant to multiple sclerosis therapy. The two-year project was funded by the German Federal Ministry of Education and Research. Bayer AG, of Leverkusen, Germany, signed an agreement to acquire the

The two pivotal studies evaluated the efficacy and safety of LATUDA as monotherapy (PREVAIL 2) or adjunctive therapy (PREVAIL 1) for the treatment of bipolar depression, and supported two supplemental new drug applications that were accepted by the FDA on Oct. 30, 2012

An investigational new drug application filing for the ALN-AS1 programs is expected in 2014...A new drug application was submitted to and accepted last year by the China Food and Drug Administration

Mylan Pharmaceuticals received final approval from the FDA for its abbreviated new drug application for this product, which is the generic version of Tricor (fenofibrate, AbbVie...Oramed Pharmaceuticals Inc., of Jerusalem, said the FDA cleared the company's investigational new drug application for its flagship product, an oral insulin capsule called ORMD-0801 for early Type II diabetes

Ltd., of Taipei, Taiwan, submitted a new drug application (NDA) for the oral formulation of nemonoxacin with the Taiwan Food and Drug Administration (TFDA) and China Food and Drug Administration (CFDA

Grayson expects RuiYi to file an investigational new drug application (IND) with the CFDA authorities within 18 to 26 months

received final approval from the FDA for its abbreviated new drug application for Zolmitriptan Tablets, 2.5 mg and 5 mg

Arbor Pharmaceuticals Inc., of Atlanta, said the FDA approved its new drug application for Nymalize (nimodipine) oral solution...DSC127 is in two U.S. Phase III trials in diabetic foot ulcers, and Derma Sciences plans to submit a new drug application to the FDA following their completion. (See BioWorld Today, Feb. 7, 2013

The injunction also requires Ranbaxy to review and verify data submitted in past drug applications to the FDA

Mirna filed its first investigational new drug application with the FDA for MRX34 earlier this year

Based on its SPA for the pivotal study, the Redwood City, Calif.-based firm "feels really good" about submitting a new drug application (NDA) to the FDA on the heels of the Phase III trial, Klaerner said

The injunction also requires Ranbaxy to review and verify data submitted in past drug applications to the FDA

Actavis Inc., of Parsippany, N.J., reported the FDA has accepted for filing its new drug application for a progestin-only transdermal contraceptive patch (Norethindrone Transdermal Delivery System) for use by women to prevent pregnancy...Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted priority review to its new drug application for simeprevir (TMC435), an NS3/4A protease inhibitor for once-daily administration with pegylated interferon and

Dyax plans to file an investigational new drug application by the end of June and, pending acceptance by the FDA, will move into a Phase I study with healthy volunteers and then begin testing the drug in patients

The company expects to report top-line results from the current study in late 2013 or early 2014 and to file a new drug application with the FDA in 2014. (See BioWorld Today, March 20, 2013

drug application, to the Osaka, Japan-based big pharma