The European Medicines Agency is pushing back against critics who accuse the agency of softening its commitment to clinical trials data transparency, saying there has been “absolutely no change in direction” in the agency’s efforts to make trial data more publicly available. Read More

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by paying particular attention to assessments of exposure and effects of the product on the body, according to new FDA draft guidance on creating versions of the complex therapies.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