The European Medicines Agency gave a positive opinion on Adasuve (staccato loxapine) by Alexza Pharmaceuticals Inc., of Mountain View, Calif., and Grupo Ferrer Internacional SA, of Barcelona, for agitation in adults with schizophrenia or bipolar disorder. The opinion was based on two randomized, multicenter Phase III studies showing statistically significant reductions in agitation from baseline compared to placebo.

Amgen Inc., of Thousand Oaks, Calif., said its board declared a 47-cents-per-share dividend for the first quarter of 2013. The dividend will be paid on March 7, 2013, to all stockholders of record as of the close of business on Feb. 13, 2013. That represents about 31 percent more than the dividend paid in each of the previous four quarters. Amgen's board also approved an increase in share repurchase authorization in the amount of $2 billion. The amount is in addition to approximately $500 million remaining under the previously announced $10 billion share repurchase program. Amgen expects that the increase in repurchase authorization will cover the company's share repurchase activity into 2014.

• BGI-Shenzhen, of Shenzhen, China, extended an all-cash tender offer to purchase all outstanding shares of common stock in Complete Genomics Inc., of Mountain View, Calif., until midnight on Dec. 31 . The offer previously expired on Dec. 14.

• Bionomics Ltd., of Adelaide, Australia, chose a lead candidate for Alzheimer's disease. The compound, BNC375, a modulator of nicotinic acetylcholine receptor (a7 nAChR), will begin GMP manufacturing scale-up and toxicology studies in preparation for an investigational new drug application.

• China Nuokang Bio-Pharmaceutical Inc., of Beijing, called a meeting of shareholders to vote on a merger plan that would take the company private, removing its shares from The Nasdaq Global Market.

• Genzyme Corp., of Cambridge Mass., a unit of Sanofi SA, and Isis Pharmaceuticals Inc., of Carlsbad, Calif., said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion for its marketing authorization application for Kynamro (mipomersen) for the treatment of patients with homozygous familial hypercholesterolemia. Genzyme plans to request a re-examination of the CHMP Opinion. An FDA advisory panel recommend approval of the drug by a 9-6 vote in October. (See BioWorld Today, Oct. 19, 2012.)

The FDA on Friday approved raxibacumab injection to treat inhalational anthrax. The monoclonal antibody (MAb), developed by Rockville, Md.-based Human Genome Sciences Inc. (HGS), a unit of GlaxoSmithKline plc, of London, is the first MAb approved under the agency's animal rule, enacted to test drugs when human testing would be considered unethical. Inhalational anthrax is a form of the infectious disease caused by breathing in the spores of Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. The drug works by neutralizing toxins produced by B. anthracis that can cause irreversible tissue injury and death. The FDA's Anti-Infective Drugs Advisory Committee voted 16 to 1, with one abstention, in support of the clinical benefit of raxibacumab to treat inhalational anthrax in early November.

• Jazz Pharmaceuticals plc, of Dublin, Ireland, said the FDA denied its citizen petition filed in July asserting that any abbreviated new drug appliation (aNDA) for a Xyrem (sodium oxybate oral solution) generic should include a proposal for a full risk evaluation and mitigation strategy, and sought that the FDA rescind any accepted aNDA for the narcolepsy drug that does not include such a proposal. An aNDA has been submitted by Roxane Laboratories Inc., of Columbus, Ohio.

• Ligand Pharmaceuticals Inc., of San Diego, and Pfizer Inc., of New York, said the FDA accepted for review a new drug application for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms and vulvar and vaginal atrophy associated with menopause, as well as the prevention of postmenopausal osteoporosis. The PDUFA date is Oct. 3, 2013.