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Avanir Pharmaceuticals announced it has received an approvable letter from the FDA for Zenvia (formerly called Neurodex) for the treatment of involuntary emotional expression disorder (IEED).
Novavax announced that the Centers for Disease Control and Prevention (CDC) has agreed to evaluate the company's H5N1 pandemic influenza vaccine candidate, including preclinical testing of the vaccine against live bird flu virus.
GlobeImmune has announced positive interim results from study GI-5005-01, a randomized, placebo-controlled, multicenter, dose-escalation, Phase 1b study of GI-5005 in patients chronically infected with hepatitis C virus (HCV).
Emisphere Technologies has announced results from its 90-day, Phase II study of its oral insulin product utilizing its eligen oral-delivery technology.
Shire Pharmaceuticals and its collaborative partner New River Pharmaceuticals announced that their investigational attention-deficit/hyperactivity disorder (ADHD) treatment, lisdexamfetamine dimesylate (also known as NRP104 or LDX), yielded a 60 percent improvement in the primary rating scale scores for symptoms of ADHD in children ages 6 to 12 who received six months of treatment in an open-label Phase III study.
Schwarz Pharma has announced that results from the second Phase III trial with oral lacosamide for adjunctive therapy of epilepsy are clinically relevant and statistically significant in both primary variables, reduction of seizure frequency and a 50 percent responder rate.
Vion Pharmaceuticals has presented data on its lead anticancer agent, Cloretazine (VNP40101M), as a single agent in a Phase II trial in patients with relapsed or refractory small-cell lung cancer.