Research and Development

FDA Sheds Light on Next-Gen Heart Drug Development Expectations

While developers of next-generation heart drugs known as PCSK9 inhibitors will need to present data showing their effectiveness at lowering cholesterol, blood pressure and inflammation, they will not be required to show reduced heart attack or stroke, according to the FDA. Read More

EMA, EUnetHTA Look to Improve Use of Clinical Data

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) have agreed to work together to help regulators and drug sponsors make the most of clinical and postmarket health data. Read More

FDA Issues Guidances on Gene/Cellular Therapies

The FDA seems to have side-stepped many of the issues raised by industry in a draft guidance on preclinical considerations for gene/cellular therapies (CGT) while extending a guidance deadline for early-stage CGT development. Read More