Branded

NEW YORK Patients with rheumatoid arthritis derive about as much benefit from a weekly injection of a biotech drug made by Bristol-Myers Squibb for the disease as they do from receiving it via IV on a monthly basis, according to late-stage clinical trial data released Monday.

EAST BRUNSWICK, N.J. Drug maker Savient Pharmaceuticals will begin shipping its treatment for chronic gout to specialty distributors at the end of this month, Savient said.

The company announced that it would begin shipping Krystexxa (pegloticase) on Nov. 30, and it would become available for prescription on Dec. 1.

INDIANAPOLIS The Food and Drug Administration has approved a new usage for a drug used to treat depression and pain.

Eli Lilly said Thursday that the FDA had approved Cymbalta (duloxetine hydrochloride) for treating chronic musculoskeletal pain. This is the fifth indication for which the agency has approved Cymbalta, after major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain and fibromyalgia, Lilly said.

MONTREAL A study presented last month before the European Respiratory Society Annual Congress determined that the branded probiotic ProbioKid reduced infectious events in children by 25% during the winter period, as compared with a placebo. The study was conducted during the winter of 2006-2007 and involved 135 healthy, school-aged children who had suffered from at least three episodes of ear-nose-throat, bronchopulmonary or gastric disorder during the course of the previous winter.

DANBURY, Conn. The Food and Drug Administration has turned down an application for an insulin product made by Biodel, Biodel said.

The drug maker announced that it received a complete response letter from the FDA for Linjeta (human insulin [rDNA origin]) for the treatment of Type 1 and Type 2 diabetes.

SILVER SPRING , Md. (Oct. 29) The Food and Drug Administration has approved a new drug for treating schizophrenia, the agency said Thursday.

The FDA announced the approval of Latuda (lurasidone hydrochloride), made by Fort Lee, N.J.-based Sunovion Pharmaceuticals. The drug is approved to treat adults with the disease, a mental illness that causes hallucinations, delusions, paranoia and disordered thinking and behavior.

CRANBURY, N.J. British drug maker GlaxoSmithKline will work with U.S.-based Amicus Therapeutics to develop a drug for a rare genetic disease.

The two companies announced a deal to develop and commercialize Amigal (migalastat hydrochloride), a treatment for Fabry disease. Under the deal, GSK will pay Amicus $30 million upfront, as well as milestone payments of up to $170 million and royalties on future sales.

MOUNTAIN VIEW, Calif. Vivus found itself foiled in its efforts to market a drug for obesity as the Food and Drug Administration turned down its regulatory approval application.