• Amgen Inc., of Thousand Oaks, Calif., said it would appeal the negative opinion on the marketing clearance of the colorectal cancer drug Vectibix (panitumumab) from the European Committee for Medicinal Products for Human Use. The drug was approved by the FDA in September 2006. Amgen's stock (NASDAQ:AMGN) closed Friday at $54.55, down 2 cents.

• Anavex Life Sciences Corp., of Geneva, said in vivo preclinical data showed that ANAVEX 1-41 and ANAVEX 2-73, muscarinic ligands with a high affinity for the sigma-1 receptor, suggest a possibly neuroprotective and anti-amnesiac efficacy in Alzheimer's disease. In mouse models, both compounds reversed the learning deficits induced by the AB25-35 peptide in a dose-dependent manner and was found to be effective in both short-term and long-term memory tests. Data were presented at the Neurosciences meeting in Montpellier, France.

• Cangene Corp., of Toronto, received a notice of compliance for its Vaccinia Immune Globulin (VIG) intravenous hyperimmune product from the Biologics and Genetic Therapies Directorate of Health Canada. The approved indication is for counteracting certain complications associated with smallpox vaccination. Cangene already has delivered a supply of the drug under a $3.2 million agreement with Health Canada. VIG was approved by the FDA in 2005.

• Novagali Pharma SA, of Evry, France, said Vekacia, a cyclosporine A drug, was granted orphan drug designation by the FDA for vernal keratoconjunctivitis, a rare and severe form of chronic allergic conjunctivitis affecting mostly children and young adults. That designation would provide Novagali with regulatory assistance for Vekacia and provide the product seven years of marketing exclusivity upon FDA approval. The product previously received orphan status in the European Union, which would provide 10 years of marketing exclusivity upon marketing approval.

• Tercica Inc., of Brisbane, Calif., said the Committee for Medicinal Products for Human Use adopted a positive opinion recommending European marketing authorization for Increlex (mecasermin) 10 mg/ml solution for injection for the long-term treatment of growth failure in children and adolescents due to severe primary insulin-like growth factor-1 deficiency, and in children with growth hormone gene deletion who have developed neutralizing antibodies to GH. Tercica expects a marketing authorization in 2-3 months from the European Medicines Agency and anticipates that Increlex, upon approval, would receive 10 years of marketing exclusivity as an orphan drug in the European Union. Increlex has been sold by Tercica in the U.S. since early 2006. It is partnered in Europe with Paris-based Ipsen SA.