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The Department of Justice is investigating a Phase III study of AstraZeneca’s (AZ) heart drug Brilinta, which analysts and experts say could revolve around allegations of data falsification. Read More
Sponsors can now begin voluntarily uploading summary results of clinical trials to the European Medicines Agency’s (EMA) newly updated EudraCT database. Read More
As the coming year approaches, EU regulators and pharma are ratcheting up their arguments for and against a plan to make more patient-level clinical trial data publicly available, beginning Jan. 1. Read More
If EU regulators and pharma cannot agree on how to handle publication of clinical trial data, drugmakers may delay filing applications in Europe to preserve exclusivity, a Pfizer official says. Read More
Starting Sept. 30, sponsors in the UK must register their clinical trials on a publicly accessible database in order for them to be approved by the Health Research Authority. Read More