We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The European Medicines Agency may postpone a trial transparency initiative that was scheduled to take effect Jan. 1, 2014, due to an overwhelming number of comments from stakeholders. Read More
Indian authorities want clinical trial sites accredited and more heavily regulated. In a new report, a panel of advisors to the Ministry of Health and Family Welfare spells out specific reforms aimed at addressing past weaknesses in the country’s clinical investigation and drug approval processes. Read More
GlaxoSmithKline’s experimental coronary heart disease drug darapladib failed to reduce heart attacks, strokes and major cardiovascular events in a closely watched Phase III clinical trial, deflating some expectations for GSK’s Phase III pipeline. Read More
The FDA has delayed Sarepta Therapeutics’ NDA submission for its Duchenne muscular dystrophy (DMD) drug because of a failure in trials of a similar drug. Read More
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
The FDA strongly recommends blinding in device pivotal trials, when possible, and notes that, even if the subject and/or the investigator cannot be blinded, devicemakers may be able to secure a blinded third-party evaluator to assess the study endpoints. Read More
An FDA plan detailing how the agency will develop and implement clinical trial data terminology standards for therapeutic areas (TA), which was released last month, could affect the way drug and biologic applications are reviewed. Read More
Clinical investigators need to improve adherence to study protocols and maintain better records of their trials, according to findings from an FDAnews-sponsored study. Read More
A proposal moving through the European Parliament to centralize data protection across member states would grant clinical trial participants the ability to demand that their trial data — including data shared between regulators and other entities — be effectively “erased.” Read More
Sponsors of direct-acting antiviral (DAA) drugs for the treatment of chronic hepatitis C got some relief in the form of a relaxed endpoint for use in late-stage studies. 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