Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.

Bristol makes its own deal with Celgene ally Dragonfly, while Gilead ends virology partnerships with Durect and Precision BioSciences.

Amplistar is pursuing an entirely new approach to cancer diagnostics, one it hopes will allow both earlier and more effective detection of the diseases. Rather than measuring tumor marker proteins (like PSA for prostate cancer, or CA-125 for ovarian cancer), Amplistar aims to identify those tumor targets that produce an immune response in the body. The company believes that antibodies generated in response to tumor antigens may be detectable in the blood earlier than tumor marker proteins.

New hunters of diagnostic biomarkers hope to improve cancer diagnosis. They envision biomarkers that will allow more accurate disease-stage monitoring, more effective choice of therapy and, ultimately, the development of therapies themselves. Despite the plethora of new technologies, tools, and genomic data, however, cancer-specific markers have provent obe difficult beasts to catch.