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FDA Approves Prolia, Amgen's New Osteoporosis Drug
Reuters reports that the U.S. Food and Drug Administration (FDA) has approved Prolia, a new osteoporosis drug from Amgen, Inc. The drug is designed to prvent fractures in post-menopausal women. Reuters says the drug just received European approval days ago.
"Denosumab is the most potent agent ever introduced into clinical practice that blocks bone degradation," Roger Perlmutter, Amgen's research chief, said in a telephone interview.
Analysts estimate the product could see annual global sales of $3.3 billion in 2014 for the world's biggest biotechnology company, according to Thomson Reuters data.
"Most of us certainly expected this drug to be approved," said Cowen and Co analyst Eric Schmidt, adding it was "a surprise that it happened before" July 25.
WedMD reports that Prolia is meant for three types of patients.
- Postmenopausal women with osteoporosis and high risk of fracture (that is, previous fracture due to osteoporosis or multiple fracture risk factors).
- Patients with osteoporosis for whom other osteoporosis treatments have failed.
- Patients who cannot tolerate other osteoporosis treatments.
WebMD also says Prolia's approval followed three years of clinical trials that showed postmenopausal women taking the drug increased bone density and had fewer fractures.
The drug requires one injection every six months. Prolioa costs $825 per injection, which is $1,650 per year. The drug is expected to be available as early as next week.
Posted on June 4, 2010
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Brown Scientists to Create New 3-D X-ray System
 Scientists at Brown University are developing a new technology that will allow doctors and scientists to see inside living animals and watch their bones move in 3-D as they run, fly, jump, swim and slither.
This high-resolution, high-speed imaging system will contribute to better treatments for knee, shoulder, wrist and back injuries and help scientists understand the evolution of complex movements, from the flight of birds to the leap of frogs.
"This will be like having X-ray vision - you'll be able to see through skin and muscle and watch a skeleton move in 3-D," said Elizabeth Brainerd, the Brown University biology professor overseeing development of the new system. "Imagine animated X-ray movies of flying bats or flexing knees. It's very cool technology that is also very important from a biomedical standpoint."
The system will be designed and built with a $1.8-million grant from the W.M. Keck Foundation, one of the nation's largest philanthropic organizations and a major supporter of pioneering discoveries in science, engineering and medical research.
The system will fill a void in medical and scientific imaging. Right now, researchers trying to understand the complex motions of bones and joints are held back by technology. Computed tomography, or CT, delivers detailed 3-D images, but CT scanners are too slow to capture rapid motion. Cinefluoroscopy, a technique that uses X-rays to view objects, can produce moving images in two dimensions, but not 3-D.
Right now it is just going to be used to study flying bats, frogs and other animals but eventually these types of x-rays could potentially be very helpful to people suffering from joint and back problems. Someday the 3-D technology could be used to study your sore elbow instead of the alligator's. Modern medicine is woefully behind on scanning technology. We are far away from the kind of technology you see in a Star Trek sickbay. Any new advancement in medical scanning is welcomed.
Photo credit: David Baier/Brown University
Posted on February 22, 2007
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Nanotubes to Heal Broken Bones?
Wired reports that researchers at the University of California at Riverside believe that they may be able to find a better way to heal bones using carbon nanotubes.
Carbon nanotubes, incredibly strong molecules just billionths of a meter wide, can function as scaffolds for bone regrowth, according to researchers led by Robert Haddon at the University of California at Riverside. They have found a way to create a stronger and safer frame than the artificial bone scaffolds currently in use.
Human bones are both organic and inorganic. The organic part is made of collagen, the most abundant protein in mammals. The inorganic component is hydroxyapatite, a type of calcium crystal. The collagen forms a sort of natural scaffold over which the calcium crystals organize into bone. The idea in Haddon's research is to use the nanotubes as substitutes for the collagen to promote new bone growth when bones have been broken or worn down.
The theory has not yet been tested on humans but the Wired article mentions several scientists that sound keen on the potential. James Mitchell Tour, a chemistry professor at Rice University, told Wired that nanotubes will be an important medical tool.
"Nanotubes are already a big deal in the rubber and elastomer industries," Tour said. "It's going to be a big deal in the medical industry. When we talk about enhancing rigidity in the medical field, one immediately thinks of bones. That's a good place to start."
What would be really terrific would be if they can be used to repair damage in severe spinal injuries or help people with osteoporosis.
Posted on September 8, 2005
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