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).

Æterna Zentaris and Keryx Biopharmaceuticals announced agreement with the FDA regarding a Special Protocol Assessment on its Phase 3 trial for perifosine (KRX-0401) for the treatment of refractory metastatic colorectal cancer.

Spectrum Pharmaceuticals announced that it has met with the FDA regarding its supplemental New Drug Application (sNDA) for Fusilev (levoleucovorin) injection for the treatment of advanced metastatic colorectal cancer.

Poniard Pharmaceuticals announced that its Phase 2 study of picoplatin in metastatic colorectal cancer (CRC) met its primary endpoint and study objectives.

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.