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The House Energy and Commerce Committee is scheduled to mark up a bill Wednesday that would encourage the development of abuse-deterrent opioids. Read More
The FDA is providing updated guidance on assessing the effects of protein-based treatments on the immune system, providing advice on how to validate results but little new information on testing protocols. Read More
A nonprofit coalition is calling for congressional action that would allow the FDA to offer formal scientific opinions on the use of medical products outside the U.S. to streamline and strengthen regulatory pathways for drugs and vaccines in less developed countries. Read More
The European Medicines Agency is recommending that sponsors use clinical trial information from adults to support the development of therapies for children. Read More
After a Phase 1 trial designed by Portuguese drugmaker Bial Laboratories left one patient dead and the hospitalization of others, a committee appointed by France’s Agency for Medicines and Health Products Safety determined that an “off-target effect” of the compound is a probable explanation for the tragedy. Read More
The European Medicines Agency and the FDA are launching investigations into Gilead Sciences’ cancer drug Zydelig following an increased rate of serious adverse events, including deaths. Read More