Teleflex Medical Corp. has recalled devices used to deliver rescue therapies to people who have overdosed on opioids, following complaints of mechanism failure leading to a "public health crisis".
According to a recent study, traditional efficacy trials have limited applicability in everyday clinical practice – an issue which researchers say needs to be amended.
As regulators push the industry to adopt adaptive studies to reduce risk to both patients and manufacturers, the FDA has finalized a guidance outlining key issues and recommendations.
The FDA has placed on clinical hold on Juno’s Ph II clinical trial of JCAR015 following the death of two patients last week and will “continue to work” to ensure patient safety, says representative.
The US FDA has ordered CTI BioPharma to halt a Phase III trial of a cancer drug candidate after patients died from “intracranial hemorrhage, cardiac failure and cardiac arrest.”
In 2016 clinical trial and real-world data will become increasingly important in the decision to prescribe medicine, Parexel President and COO Mark Goldberg told Outsourcing-Pharma.com.
It has been getting harder and harder for trial sponsors to show that drugs intended to treat neuropathic pain are effective - and the reason is surprising.
