Omthera Pharmaceuticals Inc. enrolled its first patient in a new Phase III trial designed to expand the label of its investigational therapy for high triglycerides, Epanova. Epanova is a purified mixture of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) that Omthera previously tested in two large, Phase III trials in Crohn's disease patients.

Excitement is building in advance of an FDA advisory committee meeting on Tuesday to review fidaxomicin, an antibiotic candidate being developed by Optimer Pharmaceuticals Inc. for Clostridium difficile infection (CDI).

Third Rock Ventures LLC launched a new company, Sage Therapeutics, with a $35 million Series A financing to develop new therapies for schizophrenia, depression, pain and traumatic brain injury based on modulation of GABA and glutamate neurotransmitters.

Disappointing top-line results from a third Phase III trial of Depomed Inc.'s Serada cast a shadow on the drug's prospects with the FDA. The trial studied frequency and severity of hot flash episodes in menopausal women after four weeks, 12 weeks and 24 weeks.

Enanta Pharmaceuticals Inc. is banking on bicyclolides with a new $42.7 million grant from the National Institute of Allergy and Infectious Diseases (NIAID) to support five years of development of the drugs as medical countermeasures against biodefense category A and B bacteria.

ApoLife Inc. has joined the growing ranks of platform technology companies branching out into internal drug discovery and development. At a time when other small biotech companies are struggling to secure start-up financing, ApoLife already has a revenue stream from its yeast-based antibody production business.

According to a report by the National Venture Capital Association's MedIC Coalition, FDA regulatory challenges, reimbursement concerns and an adverse financial environment are driving venture capital (VC) investment outside the U.S. and away from major disease areas.

Gout is an old-fashioned-sounding disease that many associate with aging. It is, however, a painful condition affecting 8.3 million people in the U.S., a minority of which achieve satisfactory treatment with the market-leading product, allopurinol, for reducing serum uric acid (sUA) levels. BioCryst Pharmaceuticals Inc.'s new Phase IIb top-line data showed that combining its investigational purine nucleoside phosphorlylate inhibitor, BCX4208, with a 300-mg dose of allopurinol could double the number of patients who achieve normal sUA levels. In the randomized, double-blinded, dose-response study, BCX4208 plus allopurinol was superior to allopurinol alone in patients with gout who had failed allopurinol alone.

Threshold Pharmaceuticals Inc. is wasting no time launching a Phase III randomized trial of its sarcoma drug, TH-302, following a successful end-of-Phase-II meeting with the FDA, resulting in a special protocol assessment.