Category: New Drug

Slow-Healing Bones May Get Boost From Drug

A drug that boosts the body’s production of stem cells appears to “jump-start” the bone-healing process to a point that older adults’ bones heal as fast as young people’s, suggest preliminary results released Tuesday by U.S. researchers.

Researchers at the University of Rochester Medical Center in New York gave teriparatide (Forteo) to 145 people who had bone fractures that had not healed, many for six months or more. They found that 93 percent of them showed significant healing and pain control after eight to 12 weeks.

Pfizer Cancer Drug Shows Benefits, Shares Rise

pfizer A late-stage clinical study of Pfizer Inc’s (PFE) Sutent was halted early after the drug showed significant benefit in patients with a rare form of cancer, the drugmaker said on Thursday, sending its shares up 3.5%.

An independent committee monitoring the study recommended halting it after concluding that patients on Sutent stayed free of disease progression for longer than those on placebo plus best supportive care.

The patients in the study had advanced pancreatic islet cell tumors, a rare cancer with limited treatment options, according to Pfizer.

Company says new gout treatment approved by FDA

WASHINGTON: The U.S. Food and Drug Administration has approved the first new treatment for gout in more than 40 years, a company said Saturday.

Takeda Inc. said Uloric, a once-daily drug, was approved by the FDA on Friday to fight gout, a painful joint disease that mainly strikes middle-aged men. About 5 million people in the U.S. suffer from gout, a form of arthritis caused by a build-up of uric acid in the blood.

FDA Approves Milnacipran for Fibromyalgia

Forest Laboratories and Cypress Bioscience announced January 14 that the Food and Drug Administration (FDA) has approved milnacipran (Savella), a dual serotonin- and norepinephrine-reuptake inhibitor (SNRI), for the management of fibromyalgia.

Efficacy of the drug was established in 2 pivotal US phase 3 trials, the companies note in a press statement. Treatment with 100-mg/day and 200-mg/day doses demonstrated “statistically significant and clinically meaningful” concurrent improvements in pain, patient global assessment, and physical function, the statement adds.

Zolpimist Approved for Insomnia

NovaDel Pharma’s Zolpimist (zolpidem tartrate) oral spray has been approved by the U.S. Food and Drug Administration for short-term treatment of insomnia, the drug’s maker said Monday.

Approved in 5-milligram and 10-milligram strengths, the spray contains the same active ingredient as the widely used prescription sleep aid Ambien.