U.S. Disease foundations will invest about $75 million this year in biopharmaceutical companies to fund discovery and development of new drugs and therapies for their corresponding diseases. This year's figure represents a 10-fold increase since 2000, and the figure should continue to rise. This new avenue of industry funding has been dubbed venture philanthropy.The amount of money that disease foundations contribute to industry research would not pay the development costs of even one drug today. But, the strategic timing of the funding as well as the additional resources and expertise that the foundations provide serve to enable drug discovery and development that wouldn't be undertaken otherwise and perhaps to speed that development as well.
FDA's Guidance on Supervisory Responsibilities of Investigators
The FDA's new guidance document on investigators supervisory responsibilities is useful for both experienced investigators and novices who want to understand FDA's latest thoughts about how they conduct clinical research. This article explains the draft guidance and provides step-by-step insight for investigators who need to be in compliance with the FDA.
EMEA's Bold Appointment Reflects Agency's New Broader Role
There wasn't universal rejoicing when the EMEA was born in 1995. Many politicians within the then-15 member countries of the European Union were skeptical about the need for a pan-European agency, believing it could undermine the status of their own national authorities. Meanwhile, some working in the pharmaceutical industry were concerned that the new organization might add a layer of costly bureaucracy without necessarily diminishing the difficulties in getting products approved through the various national procedures.
Eye On: Melanoma
Cutaneous melanoma is a malignancy of skin cells known as melanocytes that contain pigment and color the skin. Less frequently, melanoma may also develop within the eye (intraocular or ocular melanoma). According to the American Cancer Society, there were 62,000 cases of melanoma in the United States in 2006, which caused 8,000 deaths. CenterWatch has identified a pipeline of 17 drugs in various stages of development for melanoma treatment, many of which are biological agents or vaccines.
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