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Nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of aspirin, increase the risk of heart attack and stroke, the American Heart Association (AHA) said, recommending that these drugs not be used as the first line of treatment for patients at risk for heart disease.
Witnesses at a Senate hearing debated the costs and risks of allowing imported pharmaceuticals, with some saying a proposed bill would cause "a flood" of dangerous counterfeit drugs into the country and others claiming it would improve safety.
Astellas Pharma is moving to extend patent protection for its enlarged-prostate treatment Flomax, a blockbuster drug that generated more than $1 billion in sales last year, the company said.
A bill introduced in the Vermont Senate would allow the state to sue drugmakers for what it calls "unconscionable pricing" of prescription drugs used to treat serious public health problems.
Roche has temporarily suspended recruitment in a study of anemic advanced lung cancer patients receiving chemotherapy after an "imbalance" of deaths across the four arms of the study, the company announced.
Industry involvement in breast cancer trials may affect study design, focus and results, according to an article published in the online version of the journal Cancer.
A biogeneric approval mechanism may lead regulators to create separate rules for these types of treatments, according to former Centers for Medicare & Medicaid (CMS) Administrator Mark McClellan, who said he is optimistic that Congress will pass legislation this year easing the entry of follow-on biologics.
Bell-More Laboratories failed to properly maintain the building where it manufactures its drugs, allowing the products to become contaminated, an FDA warning letter said.
Roche sent a letter notifying cardiac transplant healthcare practitioners that it brought an early halt to a clinical trial of its drug CellCept after four heart transplant patients suffered acute rejection.