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NORD And DIA To Host Conference On Rare Diseases And Orphan Products
9/19/2011
The National Organization for Rare Disorders (NORD) and the Drug Information Association (DIA) will host the U.S. Conference on Rare Diseases and Orphan Products in Washington, D.C. October 11-13. Everyone with an interest in rare diseases or orphan products is invited.
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FDA Seeks Comment On Proposed Guidelines For High-Quality Clinical Studies
8/19/2011
The FDA recently issued draft guidance to help researchers and manufacturers design better quality clinical studies in support of premarket approval (PMA) applications for medical devices.
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Aastrom Announces Agreement From FDA On Special Protocol Assessment For Phase 3 Clinical Trial In No-Option Critical Limb Ischemia Patients
8/1/2011
Aastrom Biosciences, Inc. , the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA) for the design of the Phase 3 REVIVE-CLI clinical trial of ixmyelocel-T, the company's expanded multicellular therapy, in patients with critical limb ischemia (CLI) who have no other treatment options.
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PAREXEL Achieves 100th Asian Ethnobridging Study Milestone
7/25/2011
PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, announced today that it has achieved a significant milestone by completing its 100th Asian ethnobridging study, which is designed to help biopharmaceutical companies accelerate development for the Asia/Pacific market.
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Medidata Solutions Announces Definitive Agreement To Acquire Clinical Force
6/29/2011
Medidata Solutions, a leading global provider of SaaS-based clinical development solutions, recently announced that it has entered into a definitive agreement to acquire Clinical Force, a pioneer in providing SaaS-based clinical trial management systems (CTMS), for undisclosed proceeds.
