Food and Drug Administration medical advisers recommended approval of the first new drug in 40 years for gout. In clinical trials sponsored by Japanese drugmaker Takeda Pharmaceutical Co, Uloric´s manufacturer, an 80-milligram dose of the drug worked better than allopurinol, currently the only FDA-approved drug that prevents formation of the uric acid crystals that cause gout.

According to an FDA advisory panel, Alpharma Inc.´s experimental morphine pill Embeda is less susceptible to abuse than existing standard treatments. The FDA is scheduled to act on Alpharma's new drug application by December 30th under a six-month priority review status.

According to an FDA advisory panel, Pain Therapeutics Inc. and King Pharmaceuticals Inc.´s experimental pain pill Remoxy is less susceptible to abuse than Purdue Pharma LP´s OxyContin. Remoxy capsules contain a thick gel and were designed to resist crushing, dissolving into a liquid or other forms of misuse. Further Details.

A panel of medical experts on Monday said Pfizer Inc.´s proposed osteoporosis drug, Fablyn, has benefits for postmenopausal women, but suggested the drug be restricted to women at high-risk of fracture or those who fail other treatments. Further details.

By a 10-1 vote, a panel of outside experts urged the FDA to clear Roche’s novel RA drug Actemra. Analysts are touting the blockbuster potential of Actemra, which will help the Swiss pharmaceutical giant diversify its business

Bayer AG´s experimental anticoagulant Xarelto has been recommended for approval by the European Medicines Agency´s Committee for Medicinal Products for Human Use (CHMP). Further details.

In a vote that ended up 7-6 in favor, an advisory panel to the Food and Drug Administration (FDA) has recommended the extended use of Johnson & Johnson (J&J) antibiotic Doribax (doripenem) as a treatment against hospital-acquired pneumonia, although they voted against accepting the studies submitted to support its application. Further details.

Actelion’s Tracleer, a dual endothelin receptor antagonist, has been recommended for approval by the EMEA’s CHMP for patients with functional class II pulmonary arterial hypertension. The European Commission is expected to make a decision within the next 2 or 3 months

An FDA advisory panel has recommended the clearance of Japanese drugmaker Otsuka's investigational drug tolvaptan for hyponatremia (low sodium levels in blood) and fluid retention. Hyponatremia may be fatal among patients with chronic heart failure and cirrhosis

The U.S. Centers for Disease Control and Prevention recommends including GlaxoSmithKline’s oral rotavirus vaccine Rotarix in the childhood immunization schedule, giving pediatricians another option. The CDC already endorsed Merck & Co’s RotaTeq in 2006, which has delayed the onset of rotavirus activity in the 2007-2008 season, according to CDC data

A Food and Drug Administration (FDA) advisory panel voted unanimously to recommend Centacor – a Johnson & Johnson (J&J) unit - experimental drug ustekinumab as a psoriasis treatment. Despite the lack of data on long-term use, the risk-benefit factor weighs in its favor, said panel. In early trials, there was certain data that revealed risk of lymphoma.

A panel of expert advisors to the European Medicines Agency has recommended the approval of Merck & Co’s and Sanofi-Aventis’ cervical cancer vaccine Gardasil for the prevention of high-grade vaginal dysplastic lesions

European Medicines Agency´s (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Schering-Plough Corp´s Bridion, aimed at helping patients emerge more quickly from anesthesia.

Biotech firm GTx said an independent biometrics group recommended that a Phase 3 trial of Acapodene (toremifene citrate) 20 mg in men with high grade prostatic intraepithelial neoplasia, or HGPIN; should continue with the issued protocols, after conducting an interim analysis of the drug’s effectiveness. High grade PIN has been identified as a pre-cancerous prostatic lesion. In the U.S., about 115,000 new cases of HGPIN are diagnosed each year. If proved effective, Acapodene has the potential to become a blockbuster

Advisers to the Food and Drug Administration have recommended Eisai's experimental sedative Aquavan, developed by MGI Pharma, to calm patients during brief surgical or diagnostic procedures only if administered by health-care workers with general anesthesia training