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The FDA is developing mathematical algorithms that will compare generic drugs to their branded counterparts, according to an agency grant announcement. Read More
Stronger public-private partnerships, a streamlined clinical trials process, more funding for the FDA and beefed up safeguards on intellectual property are some of the ways to improve drug innovation, experts from government and industry said yesterday. Read More
Manufacturers of biosimilars need to demonstrate exactly how their products compare with the reference drugs as they design clinical trials, including by paying particular attention to assessments of exposure and effects of the product on the body, according to new FDA draft guidance on creating versions of the complex therapies. Read More
Proposed copyright requirements in a recent draft of the European Medicines Agency’s clinical trial data transparency policy run counter to EMA’s moves toward greater openness, researchers argue. Read More
Investigators looking to develop new therapies for children with Gaucher disease may use either multi-company, multi-arm clinical trials or data extrapolation techniques, according the FDA and European Medicines Agency. Read More
UK drug giant GlaxoSmithKline said Tuesday that its investigational coronary drug darapladib failed to reduce cardiovascular events in patients experiencing symptoms of obstructed blood flow to the heart, marking another setback for the once promising therapy. Read More