Talecris Biotherapeutics was granted orphan drug designation by the FDA for the development of an aerosol formulation of alpha1-proteinease inhibitor to treat congenital alpha1-antitrypsin (AAT) deficiency.

Genta Incorporated announced initiation of treatment in a Phase 2 trial of tesetaxel in advanced melanoma.

Optimer Pharmaceuticals announced positive top-line results from the second of two Phase 3 trials evaluating the safety and efficacy of fidaxomicin (OPT-80) in patients with Clostridium difficile Infection (CDI).

Lux Biosciences announced that a New Drug Application (NDA) has been submitted to the FDA seeking approval of Luveniq (LX211, voclosporin capsules) for the treatment of noninfectious uveitis involving the intermediate or posterior segments of the eye.

Daiichi Sankyo announced it has initiated a Phase 3 trial for edoxaban for the reduction of recurrent venous thromboembolic (VTE) complications in patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

BioNumerik Pharmaceuticals announced the treatment of the first patients in their Phase 3 trial of Tavocept (BNP7787) for primary adenocarcinoma of the lung.

Lexicon Pharmaceuticals announced positive results from its recently completed Phase 2 study of LX4211 in patients with type 2 diabetes mellitus.

Amarin Corporation announced the enrollment of patients in their two Phase 3 trials of AMR101 for the treatment of patients with high triglycerides.

Trubion Pharmaceuticals announced the initiation of a Phase 2 trial of SBI-087 for the treatment of rheumatoid arthritis (RA).

EnVivo Pharmaceuticals announced the initiation and dosing of patients in its Phase 2b study of EVP-6124 for the treatment of schizophrenia.