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Recent concerns over the safety of Cox-2 inhibitors is having a negative impact on medical research, including large studies on the prevention and treatment of cancer, rheumatoid arthritis and osteoarthritis, dementia, and other diseases, industry experts warn.
The safety of antistroke drug Plavix — one of the world’s top-selling brands — was called into question yesterday following the release of new clinical research that shows the drug might cause a high rate of recurrent ulcers.
Pfizer’s top executives denied reports yesterday that the company’s fourth quarter earnings report contained references to additional clinical data that could be used to argue that its Cox-2 inhibitor Celebrex poses heart risks.
Two new clinical studies provide further evidence that the use of anti-inflammatory Cox-2 inhibitor drugs could increase the risk of serious cardiovascular events in humans.
Mounting concerns over the safety of Cox-2 inhibitors is having a negative impact on medical research, including large studies on the prevention and treatment of cancer, rheumatoid arthritis and osteoarthritis, dementia, and other diseases, industry experts warn.
Developers of statin drugs received positive news in two clinical studies that indicated the products help reduce the body’s level of c-reactive protein (CRP), which has been associated with increased risks of coronary disease.
The FDA’s funding program for clinical trials investigating orphan drugs will undergo some changes in fiscal 2006, including alterations to the way funding limitations are established, according to a Jan. 13 notice released by the agency.
To help speed the availability of innovative medical products, HHS should create a forum that will enable investigators and developers to discuss their products with key research, regulatory and reimbursement agencies, according to an HHS task force report released Jan. 13.
The FDA next month will hold a public meeting to review the status of the Study Data Tabul-ation Model (SDTM) for clinical trial data submissions and to discuss the agency’s experience with and plans for the proposed standard format, which was developed by the Clinical Data Interchange Standards Consortium (CDISC).