The US regulatory approval of Reclast in treating patients with Paget's
disease comes after Novartis supplied responses to "approvable letters", which are issued when the FDA is prepared to approve an investigational medicine and contain conditions that must be met prior to final US approval.
Up to 1,700 patients with Paget's
disease are expected to take part.
disease: distinguishing primary and secondary lesions using immunohistochemical studies including gross cystic disease fluid protein-15 and cytokeratin 20 expression.
cousin Jock Whitney owned Easter Hero, winner of the 1929 and 1930 Cheltenham Gold Cups, but Golden Miller soon outshone him, rapidly establishing himself as the greatest steeplechaser of his era.
In a pivotal randomized, double-blind, controlled trial, 96% of patients with Paget's
disease had a therapeutic response to zoledronic acid, compared with a response in 74% receiving 60 days of oral risedronate.
More than one million Americans are known to suffer from Paget's
disease of the bone, a chronic, treatable disease in which bone cells malfunction, resulting in bone pain, osteoarthritis, deformities and fractures.
The coexistence of Paget's
disease of bone and hyperparathyroidism, first described in 1948, is still not well understood.
The data, from the landmark HORIZON (Health Outcomes and Reduced Incidence with Zoledronic Acid ONce Yearly) Clinical Development Program, provide the basis for a marketing application recently submitted by Novartis Pharma AG to the European Agency for Evaluation of Medicinal Products (EMEA) in the European Union, for the use of zoledronic acid as a treatment for Paget's
The Freeman Hospital is now among the best in the country when is comes to looking after patients with Paget's
disease, a chronic disorder that can result in enlarged and misshapen bones The condition can cause severe pain and can lead to fractures and, in some cases, disabilities.
book is a truly remarkable story of betrayal, manipulation, and deceit orchestrated by the US government on its own citizens and internationally.
He had lost control and throwing caution to the wind at first brought defeat for Earl of Uxbridge Paget's
forces on June 18, 1815.
RHEUMATOLOGISTS at Middlesbrough's James Cook University Hospital are urging people to be more aware of Paget's
disease - a common bone disorder which affects hundreds of people without many of them knowing about it.