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Tuesday, 22 June 2010
A medicine is defined as 'a substance or preparation used in treating disease'. Society expects that the benefits of medicines should substantially exceed their risks, and this expectation has been translated into governmental policy around the world. Part of the mission of the US Food and Drug Administration (FDA) is to protect the public health by assuring the safety and efficacy of medicines1. The FDA has carried out its mission by relying upon the best current scientific knowledge and practice2. By definition, gaps in current scientific knowledge and practice limit the ability of regulatory agencies, such as the FDA and the European Medicines Agency (EMEA; London), to carry out their mission. Current gaps include a limited ability to extrapolate animal data to humans3, 4, 5, the difficulty of evaluating genetic and carcinogenic risks6, 7, and our poor understanding of gender-specific responses8. It is hoped that new knowledge, technologies and tools can address these and other gaps and improve the evaluation of new drugs and medicines9, 10, 11, 12.
Pharma Increasing Developing Countries' Access to Drugs
Tuesday, 22 June 2010
U.S.-based pharmaceutical companies are working harder than they did two years ago to make medicines available to people in developing countries. European drug companies have maintained their overall lead in the area, however, according to the second Access to Medicine Index.
Drug Companies Sharing Data on Alzheimer's
Tuesday, 22 June 2010
WASHINGTON (AP) - In an unusual step, a dozen competing drug companies have agreed to share data on thousands of Alzheimer's patients in hopes that the extra information will spark new ideas for treatments.
The database being announced Friday covers 4,000 patients and counting. It was created in consultation with government regulators and the National Institutes of Health.
Contract Manufacturing Bucks Economic Downturn
Wednesday, 24 March 2010
The biopharmaceutical industry’s capacity pendulum has taken wide swings over the past decade—from shortfall to overcapacity—as companies built up production for projected pipeline products that failed to materialize. In the ramping-up process, the industry has made major investments in facilities, equipment, technology, and staff.
Lilly, Merck, And Pfizer Announce the Formation of the Asian Cancer Research Group, Inc.
Wednesday, 24 March 2010
Pfizer Inc.Eli Lilly and Company, Merck (also known as Merck Sharp & Dohme (MSD) outside the USA and Canada), and Pfizer Inc. announced the formation of the Asian Cancer Research Group, Inc., (ACRG), an independent, not-for-profit company established to accelerate research and ultimately improve treatment for patients affected with the most commonly-diagnosed cancers in Asia.
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