Shire seeks approval to make Gaucher disease drug at new plant
LEXINGTON, Mass. — British drug maker Shire is looking to make a biotech drug for a rare genetic disorder at a new manufacturing plant in Massachusetts.
The company said Tuesday that it had filed with the Food and Drug Administration and the European Medicines Agency for approval to produce the Gaucher disease drug Vpriv (velaglucerase alfa) at its Lexington, Mass., plant. The company expects to win approval to make the drug there early next year.
After gaining approval, the company said it hopes to ramp up manufacturing of the Fabry disease drug Replagal (agalsidase alfa) at its plant in Alewife, Mass., near Boston, where it currently makes Replagal and Vpriv. Replagal is approved in 46 countries, but not the United States. Currently, 1,200 people receive Vpriv and 2,800 receive Replagal worldwide, according to the company.
"Shire remains committed to meeting the unique needs of patients living with rare diseases," Shire Human Genetic Therapies SVP technical operations Bill Ciambrone said. "Accelerating the completion of our new manufacturing facility in Lexington will enable us to provide substantial additional capacity for Vpriv less than two years after launch. Once approved, this new facility will give us greater flexibility to meet the global demand for Vpriv, as well as some of our other products for rare diseases."
Study: Diabetes dashboard may help physicians better deliver care to patients
COLUMBIA, Mo. — A new tool developed by researchers at the University of Missouri improved both the efficiency and accuracy of acquiring data needed for high-quality diabetes care, according to a new study.
Researchers said the diabetes dashboard, which allows doctors to view electronic information about patients’ health conditions related to diabetes on a single computer screen, provides information about patients’ vital signs, health conditions, current medications and lab tests that may need to be performed. The study, published in Annals of Family Medicine, found that physicians who used the dashboard were able to correctly identify data they were searching for 100% of the time, compared with 94% using traditional electronic medical records. Additionally, the number of mouse clicks needed to find the information was reduced from 60 to three when using the diabetes dashboard, the researchers said.
“The diabetes dashboard is so intuitive that it makes it hard for physicians not to do the right thing,” said Richelle Koopman, associate professor of family and community medicine at the University of Missouri School of Medicine and study author. “Doctors can see, at a glance, everything that might affect their decision. This frees up their minds and helps them make better decisions about patients’ care.”
Report: Merck KGaA alleges that Merck took over its Facebook page
NEW YORK — Facebook wars happen all the time, but it’s not often that drug manufacturers duke it out online.
Bloomberg reported Wednesday that German drug maker Merck KGaA filed suit in New York Monday alleging that its U.S. competitor, Whitehouse Station, N.J.-based Merck & Co., took over its Facebook page, Facebook.com/Merck. The page currently contains content from the U.S. company, but the German Merck said it had agreed with Facebook for exclusive use of the page, Bloomberg reported, adding that the German company had said Facebook was not cooperating with its attempts to seek information about the matter. The news service reported that Merck did not respond to requests for comment.
Merck originally was the U.S. division of the German drug maker, but was forced to split off as one of the terms of the Treaty of Versailles after World War I. Today, to avoid confusion, Merck KGaA operates under the name EMD in North America, while Merck operates as MSD outside North America.