PHARMACY

Gates Foundation gives $5.6 million research grant to UM

BY Allison Cerra

COLLEGE PARK, Md. The Bill and Melinda Gates Foundation has given money to a Maryland medical school for research into the causes of diarrheal disease and identification of the pathogens that cause the infections.

The University of Maryland School of Medicine’s Center for Vaccine Development said Tuesday it was given a $5.6 million grant from the Gates Foundation, and will use the award to test samples of diarrheal diseases from Bangladesh, Mali and Kenya—countries where diarrheal disease is rapidly developing.

Diarrheal disease is caused by infections through a variety of bacteria, parasites and viruses. It accounts for at least 18 percent of deaths in children under the age of five around the world, school officials said.

Dr. James Nataro, a professor at the UM medical school and associate director of its Center for Vaccine Development, will lead the study along with a team of researchers.

The latest award is in addition to a $27.9 million grant the School of Medicine received in August 2006 from the organization to gather information to develop vaccines for diarrheal diseases and distribute them to some of the world’s poorest countries.

In July, the Institute of Human Virology at the university received a $15 million grant from the Gates Foundation to further its AIDS research and drug development.

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Orphan drug application process to ease in U.S., Europe

BY Drew Buono

WASHINGTON & LONDON The Food and Drug Administration, European Commission and European Medicines Agency have decided to ease the application process for orphan drugs, drugs that are necessary but would be expensive and unprofitable to develop, in a move aimed at increasing the development of treatments for rare diseases, according to Reuters.

The agencies have adopted a common application, which would allow drug companies to apply to both regions at the same time with one application.

Rare diseases are defined as those affecting fewer than five in 10,000 people in the European Union and fewer than 200,000 people in the United States. About 30 million people in the European Union and about 25 million Americans suffer from more than 6,000 rare diseases.

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India’s drug makers move beyond generics

BY Drew Buono

NEW DELHI, India

India’s big pharmaceutical companies are moving from generic drug manufacturing to introducing their own originally researched drug molecules, which are expected to hit the market by 2010-11, according to published reports.

Among the companies involved in research and development of the new molecules are Ranbaxy, Glenmark and Dr. Reddy’s. Altogether about 10 to 12 companies have molecules under various stages of development.

Research and development investments now account for as much as 7 percent to 9 percent of sales. For example, Ranbaxy invested $80 million in research and development in 2006-07; this year that number has gone up to $100 million.

The key for these companies will be to partner with more experienced pharmaceutical manufacturers to help conduct more original research and development on new drugs.

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